Crossover Study to Assess the Relative Bioavailability an... | NCT03329001 | Trialant
NCT03329001
Sponsor
Tesaro, Inc.
Status
Completed
Last Update Posted
Jul 25, 2024Actual
Enrollment
236Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
Niraparib Tablet
Niraparib Capsule
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03329001
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
213362
Secondary IDs
ID
Type
Description
Link
3000-01-004
Other Identifier
Tesaro
Brief Title
Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
Official Title
An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients With Advanced Solid Tumors
Acronym
Not provided
Organization
Tesaro, Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Dec 4, 2017Actual
Primary Completion Date
Dec 30, 2021Actual
Completion Date
Jun 15, 2023Actual
First Submitted Date
Oct 23, 2017
First Submission Date that Met QC Criteria
Oct 30, 2017
First Posted Date
Nov 1, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2022
Results First Submitted that Met QC Criteria
Nov 13, 2023
Results First Posted Date
Apr 26, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 17, 2024
Last Update Posted Date
Jul 25, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Tesaro, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a three stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) and Bioequivalence (BE) of niraparib administered as a tablet formulation compared to the reference capsule formulation currently marketed in the United States. Stage 3 evaluates the effect of a high-fat meal on niraparib pharmacokinetics (PK) following a single dose of the tablet. The Extension Phase of this study is to enable participants enrolled in the study to continue to receive treatment with niraparib tablets if they are tolerating it and, in the Investigator's opinion, may receive benefit.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
PARP inhibitor
niraparib
Solid Tumor
Zejula
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
236Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1: Tablet-Capsule Sequence
Experimental
Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase
Drug: Niraparib Tablet
Drug: Niraparib Capsule
Stage 1: Capsule-Tablet Sequence
Experimental
Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
Drug: Niraparib Tablet
Drug: Niraparib Capsule
Stage 2: Tablet-Capsule Sequence
Experimental
Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase.
Drug: Niraparib Tablet
Drug: Niraparib Capsule
Stage 2: Capsule-Tablet Sequence
Experimental
Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
Drug: Niraparib Tablet
Drug: Niraparib Capsule
Stage 3: High fat meal-fasted sequence
Experimental
Single dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Niraparib Tablet
Drug
Niraparib tablet formulation
Stage 1: Capsule-Tablet Sequence
Stage 1: Tablet-Capsule Sequence
Stage 2: Capsule-Tablet Sequence
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0 to Inf]) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Maximum Observed Plasma Concentration (Cmax) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Terminal Half-life (T1/2) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs-Stage 1 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key inclusion criteria:
PK Phase: To be considered eligible to participate in this study, all of the following requirements must be met:
Participants with histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumors that have failed to respond to standard therapy, has progressed despite standard therapy, or for which no standard therapy exists, and who may benefit from treatment with a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor as assessed by the Investigator.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Adequate organ function as defined: Absolute neutrophil count ≥ 1,500 per microliter (/μL) (For Stage 3: >=1000/μL); Platelets ≥ 100,000/μL; Hemoglobin ≥ 9 grams per deciliter (g/dL) (5.6 millimolar [mM]); Serum creatinine ≤ 1.5 × the upper limit of normal (ULN) or a calculated creatinine clearance ≥ 60 milliliters per minute (mL/min) using the Cockcroft-Gault equation or 24-hour urine creatinine clearance.; Total bilirubin ≤ 1.5 × ULN except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin ≤ 1.5 × ULN of the direct bilirubin; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN unless liver metastases are present, in which case, they must be ≤ 5 × ULN.
Participant has recovered to Grade 1 toxicity from prior cancer therapy (a participant with Grade 2 neuropathy or Grade 2 alopecia is an exception to this criterion and may qualify for this study).
Female participant of childbearing potential is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug.
Male participant agrees to use an adequate method of contraception and not donate sperm starting with the first dose of study drug through 90 days after the last dose of study drug.
(For Stage 3): CNS inclusion - Based on screening brain magnetic resonance imaging indicating no evidence of brain metastasis or needing immediate local therapy.
Participant is able to eat a high fat meal.
Participant is able to fast for a minimum of 10 hours before start of visit and for an additional 4 hours after study visit.
Extension Phase:
ECOG performance status of 0 to 2.
Adequate organ function as defined: Absolute neutrophil count ≥ 1,500/μL (For Stage 3: >=1000/μL); Platelets ≥ 100,000/μL; Hemoglobin ≥ 9 g/dL (5.6 mM); serum creatinine ≤ 1.5 × the ULN or a calculated creatinine clearance ≥ 60 mL/min (For Stage 3: ≥ 30 mL/min) using the Cockcroft-Gault equation or 24-hour urine creatinine clearance; Total bilirubin ≤ 1.5 × ULN except in participant with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin ≤ 1.5 × ULN of the direct bilirubin; AST and ALT ≤ 2.5 × ULN unless liver metastases are present, in which case, they must be ≤5 × ULN
Female participant of childbearing potential is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug.
Male participant agrees to use an adequate method of contraception and not donate sperm starting with the first dose of study drug through 90 days after the last dose of study drug.
Key Exclusion Criteria: PK Phase:
Known diagnosis of immunodeficiency
Symptomatic uncontrolled brain or leptomeningeal metastases.
Major surgery within 3 weeks of starting the study or participant has not recovered from any effects of any major surgery.
Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder; nonmalignant systemic disease; or active, uncontrolled infection.
Known history of myelodysplastic syndrome or acute myeloid leukemia.
Participant is currently taking any of the following P-glycoprotein (P-gp) inhibitors: amiodarone, azithromycin, captopril, carvedilol, clarithromycin, conivaptan, cyclosporine, diltiazem, dronedarone, erythromycin, felodipine, itraconazole, ketoconazole, lopinavir and ritonavir, quercetin, quinidine, ranolazine, ticagrelor, and verapamil (Does not apply for Extension Phase).
Participant taking proton pump inhibitors, antacids, or histamine 2 blockers within 48 hours prior to study drug administration (Does not apply for Extension Phase).
Participant has gastric, gastro-esophageal or esophageal cancer; participant is unable to swallow orally administered medication; or participant has gastrointestinal disorders or significant gastrointestinal resection likely to interfere with the absorption of niraparib.
Participant has known active hepatic disease
Participant has a past or current history of chronic alcohol use.
Participant has significant pleural effusion or ascites that is expected to require drainage during the PK Phase (Does not apply for Extension Phase).
For Stage 3 only: Participant is currently taking a lipase inhibitor or cholesterol absorption inhibitor, such as orlistat or ezetimibe, respectively. (Does not apply for participation in Extension Phase of this study).
Falchook G, Patnaik A, Richardson DL, Harvey RD, Sharma MR, Hafez N, Hamilton E, Piha-Paul SA, Barve M, Wise-Draper T, Patel MR, Dowlati A, Pascuzzo J, Tang SC, Faltermeier C, Malinowska IA, Shtessel L, Striha A, Potocka E. A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors. Clin Ther. 2024 Mar;46(3):228-238. doi: 10.1016/j.clinthera.2024.01.004. Epub 2024 Feb 28.
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 236 participants were enrolled. The Safety Population comprised all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study.
Recruitment Details
This was a 3-stage, single cross-over study. The study had a pharmacokinetic (PK) phase consisting of stages 1, 2, and 3 and an Extension Phase. The Extension Phase based on Investigator and Sponsor's decision provided qualifying participants continued access to niraparib therapy.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage 1: Niraparib Tablet/Capsule
Participants received a single oral dose of 300 milligrams (mg) niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety follow-up [f/u]) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
Periods
Title
Milestones
Reasons Not Completed
Stage 1: PK Phase- Period 1 (Day 1)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 22, 2020
Dec 6, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Niraparib Tablet
Stage 3: Fasted-high fat meal sequence
Experimental
Single dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal.
Drug: Niraparib Tablet
Stage 2: Tablet-Capsule Sequence
Stage 3: Fasted-high fat meal sequence
Stage 3: High fat meal-fasted sequence
Niraparib Capsule
Drug
Niraparib capsule formulation
Stage 1: Capsule-Tablet Sequence
Stage 1: Tablet-Capsule Sequence
Stage 2: Capsule-Tablet Sequence
Stage 2: Tablet-Capsule Sequence
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Apparent Total Body Clearance (CL/F) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Apparent Terminal Volume of Distribution (Vz/F) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0-t) for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0 to Inf) for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Cmax for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Tmax for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
T1/2 for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
CL/F for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Vz/F for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0-t) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0 to Inf) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Cmax for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Tmax for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
T1/2 for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
CL/F for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Vz/F for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Time From Administration of the Dose to the First Quantifiable Concentration (Tlag) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of tlag. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Up to 16 days
Number of Participants With TEAEs Leading to Discontinuation -Stage 1 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Up to 16 days
Number of Participants With TEAEs and Serious TEAEs-Stage 2 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Up to 24 days
Number of Participants With TEAEs-leading to Discontinuation Stage 2 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Up to 24 days
Number of Participants With TEAEs and Serious TEAEs-Stage 3 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Up to 45 days
Number of Participants With TEAEs-leading to Discontinuation Stage 3 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Up to 45 days
Number of Participants With TEAEs and Serious TEAEs - Extension Phase
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. A summary of number of participants with any TEAEs and serious TEAEs is presented. Serious TEAEs are subset of TEAEs. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Up to approximately 5 years 5 months
Number of Participants With TEAEs-leading to Discontinuation - Extension Phase
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. A summary of number of participants who discontinued due to any TEAEs is presented. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Up to approximately 5 years 5 months
Fresno
California
93720
United States
GSK Investigational Site
Denver
Colorado
80218
United States
GSK Investigational Site
New Haven
Connecticut
06520
United States
GSK Investigational Site
Sarasota
Florida
34232
United States
GSK Investigational Site
Atlanta
Georgia
30322
United States
GSK Investigational Site
Grand Rapids
Michigan
49546
United States
GSK Investigational Site
Jackson
Mississippi
39216
United States
GSK Investigational Site
Cincinnati
Ohio
45267
United States
GSK Investigational Site
Cleveland
Ohio
44106
United States
GSK Investigational Site
Oklahoma City
Oklahoma
73104
United States
GSK Investigational Site
Nashville
Tennessee
37203
United States
GSK Investigational Site
Dallas
Texas
75230
United States
GSK Investigational Site
Houston
Texas
77030
United States
GSK Investigational Site
San Antonio
Texas
78229
United States
GSK Investigational Site
San Marcos
Texas
92069
United States
FG001
Stage 1: Niraparib Capsule/Tablet
Participants received a single oral dose of 3x100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
FG002
Stage 2: Niraparib Tablet/Capsule
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
FG003
Stage 2: Niraparib Capsule/Tablet
Participants received a single oral dose of three 100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
FG004
Stage 3: Niraparib Tablet Fasted/Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
FG005
Stage 3: Niraparib Tablet Fed/Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
FG006
Extension Phase: Niraparib Tablet
Participants received starting dose of 300 mg or 200 mg of niraparib tablet for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib tablets dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
FG007
Extension Phase: Niraparib Capsule
Participants received starting dose of 300 mg or 200 mg of niraparib capsules for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib capsules dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
FG00015 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG00015 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Stage1:PK Phase Washout1(W)(Up to Day 7)
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG00015 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage 1: PK Phase- Period 2 (Day 1)
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG00015 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage1:PK Phase W2 (Up to Day 7)
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG00015 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage 2: PK Phase-Period 1 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00290 subjects
FG00389 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Treatment Received
FG0000 subjects
FG0010 subjects
FG00285 subjects
FG00383 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG00285 subjects
FG00383 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0036 subjects
FG004
Type
Comment
Reasons
Randomized, but did not receive treatment
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG003
Stage 2: PK Phase-W1 (Up to Day 14)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00285 subjects
FG00383 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00269 subjects
FG00371 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00216 subjects
FG00312 subjects
FG004
Type
Comment
Reasons
Deemed unevaluable
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stage 2: PK Phase- Period 2 (Day 15)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00269 subjects
FG00371 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00269 subjects
FG00371 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage2:PK Phase W2 (Up to Day 7)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00269 subjects
FG00371 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00264 subjects
FG00366 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0035 subjects
FG004
Type
Comment
Reasons
Participant had paracentesis
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stage 3: PK Phase- Period 1 (Day 1)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00414 subjects
FG00514 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stage 3: PK Phase-W1 (Up to Day 14)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00411 subjects
FG00512 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage 3: PK Phase- Period 2 (Day 15)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00411 subjects
FG00512 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Vomiting within protocol-specified hours of dose administration
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stage3:PK Phase W2 (Up to Day 7)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00410 subjects
FG00511 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Extension Phase(Approx 5 Years 5 Months)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG006124 subjects
FG00766 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline characteristics were presented for Safety Population, all participants who received any amount of niraparib during the PK phase of study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1: Niraparib Tablet/Capsule
Participants received a single oral dose of 300 milligrams (mg) niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety follow-up [f/u]) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
BG001
Stage 1: Niraparib Capsule/Tablet
Participants received a single oral dose of 3x100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 7 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
BG002
Stage 2: Niraparib Tablet/Capsule
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 3 capsules of 100 mg niraparib in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
BG003
Stage 2: Niraparib Capsule/Tablet
Participants received a single oral dose of three 100 mg niraparib capsules in a fasted state in Period 1, followed by a wash-out period of 14 days. In Period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
BG004
Stage 3: Niraparib Tablet Fasted/Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
BG005
Stage 3: Niraparib Tablet Fed/Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in Period 1, followed by a wash-out period of 14 days. In period 2, participants received a single oral dose of 300 mg niraparib tablet in a fasted state followed by a 7-day wash-out period. After the last dose of niraparib, participants who did not enter the Extension Phase were followed for up to 30 days (safety f/u) while participants eligible for Extension Phase proceeded for Extension Phase screening. Eligible participants then entered the Extension Phase, where they received 300 mg or 200 mg niraparib tablets or capsules for once daily dosing depending on their body weight and platelet count.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015
BG00114
BG00285
BG00383
BG00414
BG00514
BG006225
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<18 to <65 years
BG0005
BG0017
BG00243
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0019
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00014
BG00114
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Bioavailability (BA) Evaluable Population included all participants who completed both PK Periods and had sufficient PK sample collection to accurately estimate PK parameters, without significant niraparib carryover (Baseline concentration >5 percent (%) of maximum observed plasma concentration [Cmax]), in both Periods.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
OG001
Stage 1: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
Units
Counts
Participants
OG00023
OG00123
Title
Denominators
Categories
Title
Measurements
OG00014900± 43.0
OG00116100± 41.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of geometric least square mean
0.9110
2-Sided
90
0.8550
0.9706
Relative bioavailability (AUC[tablet]/AUC[capsule]) was assessed using analysis of variance (ANOVA) model accounting for sequence, participants nested with sequences, period and treatment.
Other
Primary
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0 to Inf]) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BA Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
OG001
Stage 1: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
Units
Counts
Participants
Primary
Maximum Observed Plasma Concentration (Cmax) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BA Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
OG001
Stage 1: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
Units
Counts
Participants
OG000
Primary
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BA Evaluable Population
Posted
Median
Full Range
Hours
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
OG001
Stage 1: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
Units
Counts
Participants
OG000
Primary
Terminal Half-life (T1/2) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BA Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
OG001
Stage 1: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
Units
Counts
Participants
OG000
Primary
Apparent Total Body Clearance (CL/F) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BA Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
OG001
Stage 1: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
Units
Counts
Participants
OG000
Primary
Apparent Terminal Volume of Distribution (Vz/F) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BA Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
OG001
Stage 1: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
Units
Counts
Participants
OG000
Primary
AUC(0-t) for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Bioequivalence (BE) Evaluable Population included all participants who completed both the Study Drug and Washout/PK and had sufficient PK sample collection to accurately estimate PK parameters, without significant niraparib carryover and without events or protocol deviations deemed affect PK, in both Periods. Only those participants with estimable PK parameter data in both periods were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
OG001
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
Primary
AUC(0 to Inf) for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
OG001
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
Units
Counts
Participants
Primary
Cmax for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BE Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
OG001
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
Units
Counts
Participants
OG000
Primary
Tmax for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BE Evaluable Population
Posted
Median
Full Range
Hours
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
OG001
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
Units
Counts
Participants
OG000
Primary
T1/2 for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BE Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
OG001
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
Units
Counts
Participants
OG000
Primary
CL/F for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
OG001
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
Units
Counts
Participants
Primary
Vz/F for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
BE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
OG001
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
Units
Counts
Participants
Primary
AUC(0-t) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Food Effect (FE) Evaluable Population included all participants who completed both PK periods and had sufficient PK sample collection to accurately estimate PK parameters in both periods. Participants meeting non-evaluability criteria or having significant niraparib carryover (Baseline concentration >5% of Cmax) were completely excluded from the FE Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Primary
AUC(0 to Inf) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
FE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Units
Counts
Participants
Primary
Cmax for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
FE Evaluable Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Units
Counts
Participants
OG000
Primary
Tmax for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
FE Evaluable Population.
Posted
Median
Full Range
Hours
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Units
Counts
Participants
OG000
Primary
T1/2 for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
FE Evaluable Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Units
Counts
Participants
OG000
Primary
CL/F for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
FE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Units
Counts
Participants
Primary
Vz/F for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
FE Evaluable Population. Only those participants with estimable PK parameter data available in both Periods were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Units
Counts
Participants
Primary
Time From Administration of the Dose to the First Quantifiable Concentration (Tlag) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of tlag. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
FE Evaluable Population.
Posted
Median
Full Range
Hours
Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs-Stage 1 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Safety Population comprised of all participants who received any amount of niraparib during the Stage 1 PK Phase of the study.
Posted
Count of Participants
Participants
Up to 16 days
ID
Title
Description
OG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
OG001
Stage 1: Niraparib Capsule
Secondary
Number of Participants With TEAEs Leading to Discontinuation -Stage 1 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Safety Population comprised of all participants who received any amount of niraparib during the Stage 1 PK Phase of the study.
Posted
Count of Participants
Participants
Up to 16 days
ID
Title
Description
OG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
OG001
Stage 1: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
Secondary
Number of Participants With TEAEs and Serious TEAEs-Stage 2 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Safety Population comprised of all participants who received any amount of niraparib during the Stage 2 PK Phase of the study.
Posted
Count of Participants
Participants
Up to 24 days
ID
Title
Description
OG000
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
OG001
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
Secondary
Number of Participants With TEAEs-leading to Discontinuation Stage 2 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Safety Population comprised of all participants who received any amount of niraparib during the Stage 2 PK Phase of the study.
Posted
Count of Participants
Participants
Up to 24 days
ID
Title
Description
OG000
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
OG001
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
Units
Counts
Secondary
Number of Participants With TEAEs and Serious TEAEs-Stage 3 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Safety Population comprised of all participants who received any amount of niraparib during the Stage 3 PK Phase of the study.
Posted
Count of Participants
Participants
Up to 45 days
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Secondary
Number of Participants With TEAEs-leading to Discontinuation Stage 3 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Safety Population comprised of all participants who received any amount of niraparib during the Stage 3 PK Phase of the study.
Posted
Count of Participants
Participants
Up to 45 days
ID
Title
Description
OG000
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
OG001
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Units
Secondary
Number of Participants With TEAEs and Serious TEAEs - Extension Phase
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that, at any dose; results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. A summary of number of participants with any TEAEs and serious TEAEs is presented. Serious TEAEs are subset of TEAEs. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Safety Population comprised of all participants who received any amount of niraparib in the Open-Label Extension Phase of the study.
Posted
Count of Participants
Participants
Up to approximately 5 years 5 months
ID
Title
Description
OG000
Extension Phase: Niraparib Tablet
Participants received starting dose of 300 mg or 200 mg of niraparib tablet for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib tablets dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
OG001
Extension Phase: Niraparib Capsule
Secondary
Number of Participants With TEAEs-leading to Discontinuation - Extension Phase
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. A summary of number of participants who discontinued due to any TEAEs is presented. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Safety Population comprised of all participants who received any amount of niraparib in the Open-Label Extension Phase of the study.
Posted
Count of Participants
Participants
Up to approximately 5 years 5 months
ID
Title
Description
OG000
Extension Phase: Niraparib Tablet
Participants received starting dose of 300 mg or 200 mg of niraparib tablet for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib tablets dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
OG001
Extension Phase: Niraparib Capsule
Participants received starting dose of 300 mg or 200 mg of niraparib capsules for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib capsules dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
Time Frame
All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.
Description
Safety Population comprised of all participants who received any amount of niraparib during the PK Phase and Extension Phase of the study. MedDRA version (v) used for PK Phase was 24.1 and Extension Phase was 26.0.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Stage 1: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
0
29
0
29
2
29
EG001
Stage 1: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
0
29
0
29
7
29
EG002
Stage 2: Niraparib Tablet
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
2
156
10
156
49
156
EG003
Stage 2: Niraparib Capsule
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 2 PK Phase.
5
152
10
152
37
152
EG004
Stage 3: Niraparib Tablet Fasted
Participants received a single oral dose of 300 mg niraparib tablet in a fasted state in either Period 1 or Period 2 of Stage 3 PK Phase.
2
26
4
26
6
26
EG005
Stage 3: Niraparib Tablet Fed
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
0
25
2
25
5
25
EG006
Extension Phase: Niraparib Tablet
Participants received starting dose of 300 mg or 200 mg of niraparib tablet for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib tablets dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
15
124
40
124
113
124
EG007
Extension Phase: Niraparib Capsule
Participants received starting dose of 300 mg or 200 mg of niraparib capsules for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib capsules dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.
3
66
20
66
64
66
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0022 affected156 at risk
EG0031 affected152 at risk
EG0041 affected26 at risk
EG0050 affected25 at risk
EG0063 affected124 at risk
EG0072 affected66 at risk
Constipation
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0022 affected156 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0021 affected156 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0021 affected156 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0021 affected156 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0021 affected156 at risk
EG003
Sepsis
Infections and infestations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0021 affected156 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0021 affected156 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Brain oedema
Nervous system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0021 affected156 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0029 affected156 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0021 affected156 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Infection
Infections and infestations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Pneumonia
Infections and infestations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Cellulitis
Infections and infestations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Hepatic infection
Infections and infestations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Urosepsis
Infections and infestations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Dizziness
Nervous system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Unresponsive to stimuli
Nervous system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Tachycardia
Cardiac disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Asthenia
General disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Chest pain
General disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Death
General disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Pyrexia
General disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Blood bilirubin increased
Investigations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Myocardial necrosis marker increased
Investigations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Hypotension
Vascular disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0001 affected29 at risk
EG0015 affected29 at risk
EG00217 affected156 at risk
EG00313 affected152 at risk
EG0042 affected26 at risk
EG0052 affected25 at risk
EG00647 affected124 at risk
EG00728 affected66 at risk
Vomiting
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0001 affected29 at risk
EG0012 affected29 at risk
EG00210 affected156 at risk
EG003
Fatigue
General disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0001 affected29 at risk
EG0012 affected29 at risk
EG00212 affected156 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG00216 affected156 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0029 affected156 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Platelet count decreased
Investigations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Headache
Nervous system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Weight decreased
Investigations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Blood creatinine increased
Investigations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
White blood cell count decreased
Investigations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Asthenia
General disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Dizziness
Nervous system disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Insomnia
Psychiatric disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Hypertension
Vascular disorders
MedDRAv(24.1)v(26.0)
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected29 at risk
EG0020 affected156 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Participant had incorrectly overdosed and removed from PK phase
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Participant admitted to emergency room for elevated serum creatinine
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Participant unable to complete due to Tornado in site area
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Participant non-compliance
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Vomiting within protocol-specified hours of dose administration
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Disease progression per Investigator Decision
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Participant forgot appointment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Participant missed PK sampling in Period 1 Day 8
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Deemed unevaluable
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Participant was not in fasted state and therefore was outside of protocol compliance
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Disease progression per Investigator Decision
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
11 subjects
FG00512 subjects
FG0060 subjects
FG0070 subjects
3 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Clinical progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
11 subjects
FG00512 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
10 subjects
FG00511 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
10 subjects
FG00511 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG00653 subjects
FG00736 subjects
0 subjects
FG0050 subjects
FG00671 subjects
FG00730 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG00622 subjects
FG00714 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0064 subjects
FG0070 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00615 subjects
FG0073 subjects
Other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00630 subjects
FG00713 subjects
38
BG0046
BG0059
BG006108
>=65 to <75 years
BG0009
BG0014
BG00227
BG00332
BG0047
BG0051
BG00680
>=75 years
BG0001
BG0013
BG00215
BG00313
BG0041
BG0054
BG00637
48
BG00348
BG0045
BG0056
BG006125
Male
BG0006
BG0015
BG00237
BG00335
BG0049
BG0058
BG006100
63
BG00362
BG0048
BG00510
BG006171
African American
BG0001
BG0010
BG00211
BG00311
BG0045
BG0050
BG00628
Asian
BG0000
BG0010
BG0025
BG0033
BG0040
BG0050
BG0068
American Indian or Alaska Native
BG0000
BG0010
BG0022
BG0030
BG0040
BG0050
BG0062
Unknown
BG0000
BG0010
BG0024
BG0037
BG0041
BG0054
BG00616
OG000
23
OG00123
Title
Denominators
Categories
Title
Measurements
OG00016200± 44.5
OG00117200± 41.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of geometric least square mean
0.9216
2-Sided
90
0.8631
0.9841
Relative bioavailability (AUC[tablet]/AUC[capsule]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.
Other
23
OG00123
Title
Denominators
Categories
Title
Measurements
OG000451± 47.8
OG001467± 50.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of geometric least square mean
0.9483
2-Sided
90
0.8489
1.0593
Relative bioavailability (Cmax[tablet]/Cmax[capsule]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.
Other
23
OG00123
Title
Denominators
Categories
Title
Measurements
OG0004.05(1.98 to 8.00)
OG0014.00(1.52 to 25.02)
23
OG00123
Title
Denominators
Categories
Title
Measurements
OG00047.3± 22.2
OG00143.8± 23.1
23
OG00123
Title
Denominators
Categories
Title
Measurements
OG00018.5± 44.5
OG00117.4± 41.8
23
OG00123
Title
Denominators
Categories
Title
Measurements
OG0001260± 45.4
OG0011100± 43.1
Units
Counts
Participants
OG000107
OG001107
Title
Denominators
Categories
Title
Measurements
OG00017070± 57.1
OG00117730± 54.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of geometric least square mean
0.9594
2-Sided
90
0.9199
1.0006
Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.
Equivalence
Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-t
OG00098
OG00198
Title
Denominators
Categories
Title
Measurements
OG00017760± 55.3
OG00118470± 53.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of geometric least square mean
0.9566
2-Sided
90
0.9164
0.9986
Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.
Equivalence
Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-inf
108
OG001108
Title
Denominators
Categories
Title
Measurements
OG000519.5± 49.5
OG001538.4± 49.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of geometric least square mean
0.9619
2-Sided
90
0.9124
1.0140
Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.
Equivalence
Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for Cmax
108
OG001108
Title
Denominators
Categories
Title
Measurements
OG0005.00(1.55 to 8.00)
OG0014.97(0.970 to 23.8)
108
OG001108
Title
Denominators
Categories
Title
Measurements
OG00047.94± 26.4
OG00150.17± 26.1
OG000
98
OG00198
Title
Denominators
Categories
Title
Measurements
OG00016.89± 55.3
OG00116.25± 53.5
OG000
98
OG00198
Title
Denominators
Categories
Title
Measurements
OG0001128± 51.1
OG0011128± 50.9
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
Title
Measurements
OG00020100± 63.9
OG00125990± 52.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of geometric least square mean
1.3154
2-Sided
90
1.1742
1.4735
Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.
Other
OG00018
OG00118
Title
Denominators
Categories
Title
Measurements
OG00023600± 78.5
OG00129770± 65.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of geometric least square mean
1.2771
2-Sided
90
1.1537
1.4137
Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.
Other
19
OG00119
Title
Denominators
Categories
Title
Measurements
OG000704.1± 57.0
OG001774.6± 47.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of geometric least square mean
1.1129
2-Sided
90
0.9408
1.3164
Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.
Other
19
OG00119
Title
Denominators
Categories
Title
Measurements
OG0004.88(2.97 to 7.10)
OG0015.97(0.980 to 11.1)
19
OG00119
Title
Denominators
Categories
Title
Measurements
OG00046.39± 20.5
OG00146.08± 22.4
OG000
18
OG00118
Title
Denominators
Categories
Title
Measurements
OG00012.71± 78.5
OG00110.08± 65.2
OG000
18
OG00118
Title
Denominators
Categories
Title
Measurements
OG000833.8± 83.5
OG001651.4± 54.3
19
OG00119
Title
Denominators
Categories
Title
Measurements
OG0000.00(0.00 to 0.970)
OG0010.00(0.00 to 2.93)
Participants received a single oral dose of 300 mg (3x100 mg capsules) niraparib in a fasted state in either Period 1 or Period 2 of Stage 1 PK Phase.
Units
Counts
Participants
OG00029
OG00129
Title
Denominators
Categories
TEAE
Title
Measurements
OG0009
OG00112
Serious TEAE
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG00029
OG00129
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG000156
OG001152
Title
Denominators
Categories
TEAE
Title
Measurements
OG00086
OG00173
Serious TEAE
Title
Measurements
OG00010
OG00110
Participants
OG000156
OG001152
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
Participants received a single oral dose of 300 mg niraparib tablet in a fed state with a high fat meal in either Period 1 or Period 2 of Stage 3 PK Phase.
Units
Counts
Participants
OG00026
OG00125
Title
Denominators
Categories
TEAE
Title
Measurements
OG0008
OG00112
Serious TEAE
Title
Measurements
OG0004
OG0012
Counts
Participants
OG00026
OG00125
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
Participants received starting dose of 300 mg or 200 mg of niraparib capsules for QD dosing orally or 3 x 100 mg or 2 x 100 mg for QD niraparib capsules dosing orally in the Extension Phase based on participant's baseline actual body weight or platelet count.