Comparison of Daprodustat Formulations Produced by Two Me... | NCT04640311 | Trialant
NCT04640311
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Apr 10, 2025Actual
Enrollment
259Actual
Phase
Phase 1
Conditions
Anaemia
Interventions
Daprodustat
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04640311
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
213022
Secondary IDs
Not provided
Brief Title
Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants
Official Title
A Two-part, Randomized, Double-blind, Single-dose, Crossover Study to Compare Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Adult Volunteers
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Apr 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 18, 2020Actual
Primary Completion Date
May 18, 2021Actual
Completion Date
May 18, 2021Actual
First Submitted Date
Nov 18, 2020
First Submission Date that Met QC Criteria
Nov 18, 2020
First Posted Date
Nov 23, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Apr 19, 2022
Results First Submitted that Met QC Criteria
Apr 19, 2022
Results First Posted Date
Jan 26, 2023Actual
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
Apr 2, 2025
Last Update Posted Date
Apr 10, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
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 study is comprised of two discrete Parts. Part A is a 3-period cross over evaluating relative bioavailability. Part B is a 2-period cross over evaluating bioequivalence. There will be a minimum of a 7-day washout period between treatment periods. Participants will participate in Part A or Part B, but not both. Approximately 200 participants will be included in the study.
Detailed Description
Not provided
Conditions Module
Conditions
Anaemia
Keywords
Daprodustat
Pharmacokinetic
Bioequivalence
Bioavailability
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
259Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Daprodustat Dissolution 1/Dissolution 2/Reference
Experimental
Drug: Daprodustat
Part A: Daprodustat Dissolution 2/Reference/Dissolution 1
Experimental
Drug: Daprodustat
Part A: Daprodustat Reference/Dissolution 1/Dissolution 2
Experimental
Drug: Daprodustat
Part B: Daprodustat Process 1/ Process 2
Experimental
Drug: Daprodustat
Part B: Daprodustat Process 2/ Process 1
Experimental
Drug: Daprodustat
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Daprodustat
Drug
Daprodustat will be available as oral tablets.
Part A: Daprodustat Dissolution 1/Dissolution 2/Reference
Part A: Daprodustat Dissolution 2/Reference/Dissolution 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Area Under the Concentration-time Curve (AUC) From Zero (Pre-dose) to Time of Last Quantifiable Concentration (AUC[0-t]) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part B: AUC(0-t) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part A: Maximum Observed Plasma Concentration (Cmax) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part B: Cmax Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Secondary Outcomes
Measure
Description
Time Frame
Part A: AUC From Zero Time (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator and/or the Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Participants with body weight more than or equal to (>=) 45 kilogram (kg) and body mass index (BMI) within the range 19-31 kg per meter square (Kg/m^2).
Male or female
A female participant is eligible to participate if she is not breastfeeding, and at least; not pregnant as confirmed by pregnancy testing or not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period to the follow-up visit.
Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
Participants with history of malignancy within the prior 2 years or currently receiving treatment for cancer. The only exception is localized squamous- or basal-cell carcinoma of the skin definitively treated 12 weeks or more prior to enrolment.
Participants unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise participant safety.
Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 30 days prior to Day 1 in this study. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
Current enrolment or past participation (administration of last dose of investigational study treatment) within the last 30 days (or 5 half-lives, whichever is longer) before Day 1 in this study in any other clinical study involving an investigational study intervention or any other type of medical research.
Part A participants may not participate in Part B, and Part B participants may not participate in Part A if enrolment is concurrent or overlaps.
Participants with positive pre-study drug/alcohol screen.
Participants with regular use of known drugs of abuse.
Participants with a positive laboratory confirmation of Coronavirus disease 2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19.
Participants with regular alcohol consumption within 6 months prior to the study.
Participants with urinary cotinine levels indicative of smoking or history or regular use of tobacco or nicotine containing products (nicotine patches or vaporizing devices) within 6 months prior to screening.
Participants with sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Shaddinger B, Mahar KM, Sprys M, Andrews SM, Chattoraj S, Israni R, Cobitz A. Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study. Clin Pharmacol Drug Dev. 2023 Jul;12(7):739-748. doi: 10.1002/cpdd.1257. Epub 2023 May 1.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
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 259 participants (52 in Part A and 207 in Part B) were enrolled in the study (Safety Population: It comprised of all randomized participants who have taken at least 1 dose of study intervention).
Recruitment Details
Participants were enrolled across 4 centers in the United States. This study consisted of two parts; Part A (3-period crossover study) and Part B (2-period crossover study).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Daprodustat DP 1 Process 2/Daprodustat DP 2 Process 2/Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 milligrams (mg) tablets with dissolution profile (DP) 1 made by Process 2 (high shear wet granulation) in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets made by reference Process 1 (twin screw granulation) in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.
Periods
Title
Milestones
Reasons Not Completed
Part A:Treatment Period 1 (Up to 2 Days)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
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
Aug 21, 2020
Mar 28, 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
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Part A: Daprodustat Reference/Dissolution 1/Dissolution 2
Part B: Daprodustat Process 1/ Process 2
Part B: Daprodustat Process 2/ Process 1
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part A: Time of Occurrence of Cmax (Tmax) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Terminal Phase Half-life (T1/2) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Apparent Clearance Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part A: Apparent Volume of Distribution Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
Part B: AUC(0-inf) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: Tmax Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: T1/2 Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: Apparent Clearance Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Part B: Apparent Volume of Distribution Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
Overland Park
Kansas
66212
United States
GSK Investigational Site
Las Vegas
Nevada
89113
United States
GSK Investigational Site
Austin
Texas
78744
United States
FG001
Part A: Daprodustat DP 2 Process 2/ Daprodustat Process 1 / Daprodustat DP 1 Process 2
Participants received a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.
FG002
Part A: Daprodustat Process 1 / Daprodustat DP 1 Process 2/ Daprodustat DP 2 Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.
FG003
Part B: Daprodustat 1 mg Process 2/ Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 1 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG004
Part B: Daprodustat 1 mg Process 1/Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 1 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG005
Part B: Daprodustat 2 mg Process 2/Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG006
Part B: Daprodustat 2 mg Process 1/ Daprodustat 2 mg Process 2
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG007
Part B: Daprodustat 4 mg Process 2/ Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG008
Part B: Daprodustat 4 mg Process 1/Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG009
Part B: Daprodustat 6 mg Process 2/Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 6 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG010
Part B: Daprodustat 6 mg Process 1/Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 6 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG011
Part B: Daprodustat 8 mg Process 2/Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 8 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG012
Part B: Daprodustat 8 mg Process 1/Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 8 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
FG00016 subjects
FG00118 subjects
FG00218 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG00015 subjects
FG00116 subjects
FG00218 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Type
Comment
Reasons
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawn by sponsor due to impact of inclement weather events
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Part A: Washout 1 (Up to 7 Days)
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00116 subjects
FG00218 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG00015 subjects
FG00116 subjects
FG00218 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part A:Treatment Period 2 (Up to 2 Days)
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00116 subjects
FG00218 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG00012 subjects
FG00111 subjects
FG00210 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0015 subjects
FG0028 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawn by sponsor due to impact of inclement weather events
FG0003 subjects
FG0015 subjects
FG0026 subjects
FG003
Part A: Washout 2 (Up to 7 Days)
Type
Comment
Milestone Data
STARTED
FG00012 subjects
FG00111 subjects
FG00210 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG00012 subjects
FG00111 subjects
FG00210 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part A:Treatment Period 3 (Up to 2 Days)
Type
Comment
Milestone Data
STARTED
FG00012 subjects
FG00111 subjects
FG00210 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG00012 subjects
FG00111 subjects
FG00210 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part B:Treatment Period 1 (Up to 2 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00321 subjects
FG00419 subjects
FG00521 subjects
FG00622 subjects
FG00721 subjects
FG00821 subjects
FG00921 subjects
FG01021 subjects
FG01120 subjects
FG01220 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00320 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part B: Washout 1 (Up to 7 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00320 subjects
FG00419 subjects
FG00520 subjects
FG00620 subjects
FG00721 subjects
FG00819 subjects
FG00921 subjects
FG01020 subjects
FG01120 subjects
FG01220 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00320 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part B: Treatment Period 2(Up to 2 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00320 subjects
FG00419 subjects
FG00520 subjects
FG00620 subjects
FG00721 subjects
FG00819 subjects
FG00921 subjects
FG01020 subjects
FG01120 subjects
FG01220 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00320 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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Daprodustat DP 1 Process 2/Daprodustat DP 2 Process 2/Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 milligrams (mg) tablets with dissolution profile (DP) 1 made by Process 2 (high shear wet granulation) in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets made by reference Process 1 (twin screw granulation) in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.
BG001
Part A: Daprodustat DP 2 Process 2/ Daprodustat Process 1 / Daprodustat DP 1 Process 2
Participants received a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.
BG002
Part A: Daprodustat Process 1 / Daprodustat DP 1 Process 2/ Daprodustat DP 2 Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets with DP 1 made by Process 2 in Treatment Period 2. Participants were administered a single oral dose of daprodustat 4 mg tablets with DP 2 made by Process 2 in Treatment Period 3. There was a washout of at least 7 days after daprodustat dosing in Treatment Periods 1 and 2. Participants were followed up for 7 days after last dose in Treatment Period 3.
BG003
Part B: Daprodustat 1 mg Process 2/ Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 1 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG004
Part B: Daprodustat 1 mg Process 1/Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 1 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG005
Part B: Daprodustat 2 mg Process 2/Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG006
Part B: Daprodustat 2 mg Process 1/ Daprodustat 2 mg Process 2
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 2 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG007
Part B: Daprodustat 4 mg Process 2/ Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG008
Part B: Daprodustat 4 mg Process 1/Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 4 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG009
Part B: Daprodustat 6 mg Process 2/Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 6 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG010
Part B: Daprodustat 6 mg Process 1/Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 6 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG011
Part B: Daprodustat 8 mg Process 2/Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in Treatment Period 1 followed by a single oral dose of daprodustat 8 mg tablets made by Process 1 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG012
Part B: Daprodustat 8 mg Process 1/Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in Treatment Period 1 followed by a single oral dose of daprodustat 8 mg tablets made by Process 2 in Treatment Period 2. There was a washout of at least 7 days after daprodustat dosing in Treatment Period 1. Participants were followed up for 7 days after last dose in Treatment Period 2.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG00118
BG00218
BG00321
BG00419
BG00521
BG00622
BG00721
BG00821
BG00921
BG01021
BG01120
BG01220
BG013259
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian - South East Asian Heritage
BG0000
BG0010
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
Part A: Area Under the Concentration-time Curve (AUC) From Zero (Pre-dose) to Time of Last Quantifiable Concentration (AUC[0-t]) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Pharmacokinetic Population comprised of all participants in the Safety Population (All randomized participants who have taken at least 1 dose of study intervention) who had at least 1 non-missing Pharmacokinetic assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
ID
Title
Description
OG000
Part A: Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.
OG001
Part A: Daprodustat Process 2 Dissolution Profile 1
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
OG002
Part A: Daprodustat Process 2 Dissolution Profile 2
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
Units
Counts
Participants
OG00035
OG00135
OG00234
Title
Denominators
Categories
Title
Measurements
OG000155.5± 14.7
OG001159.9± 14.7
OG002158.5± 14.7
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
Geometric mean ratio
1.028
2-Sided
90
0.9699
1.090
Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.
Other
OG000
OG002
Primary
Part B: AUC(0-t) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
ID
Title
Description
OG000
Part B: Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG001
Part B: Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG002
Part B: Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2
Primary
Part A: Maximum Observed Plasma Concentration (Cmax) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
ID
Title
Description
OG000
Part A: Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.
OG001
Part A: Daprodustat Process 2 Dissolution Profile 1
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
OG002
Part A: Daprodustat Process 2 Dissolution Profile 2
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
Primary
Part B: Cmax Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods. The geometric coefficient of variation is model adjusted and is a within-participant coefficient of variation. Analysis was performed using a mixed effect model.
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
ID
Title
Description
OG000
Part B: Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG001
Part B: Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG002
Part B: Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2
Secondary
Part A: AUC From Zero Time (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours* nanograms per milliliter
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
ID
Title
Description
OG000
Part A: Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.
OG001
Part A: Daprodustat Process 2 Dissolution Profile 1
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
OG002
Part A: Daprodustat Process 2 Dissolution Profile 2
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
Secondary
Part A: Time of Occurrence of Cmax (Tmax) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
ID
Title
Description
OG000
Part A: Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.
OG001
Part A: Daprodustat Process 2 Dissolution Profile 1
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
OG002
Part A: Daprodustat Process 2 Dissolution Profile 2
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
Secondary
Part A: Terminal Phase Half-life (T1/2) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
ID
Title
Description
OG000
Part A: Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.
OG001
Part A: Daprodustat Process 2 Dissolution Profile 1
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
OG002
Part A: Daprodustat Process 2 Dissolution Profile 2
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
Secondary
Part A: Apparent Clearance Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
ID
Title
Description
OG000
Part A: Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.
OG001
Part A: Daprodustat Process 2 Dissolution Profile 1
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
OG002
Part A: Daprodustat Process 2 Dissolution Profile 2
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
Secondary
Part A: Apparent Volume of Distribution Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1, 2 and 3
ID
Title
Description
OG000
Part A: Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.
OG001
Part A: Daprodustat Process 2 Dissolution Profile 1
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
OG002
Part A: Daprodustat Process 2 Dissolution Profile 2
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
Secondary
Part B: AUC(0-inf) Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours* nanograms per milliliter
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
ID
Title
Description
OG000
Part B: Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG001
Part B: Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG002
Part B: Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2
Secondary
Part B: Tmax Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population
Posted
Median
Full Range
Hours
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
ID
Title
Description
OG000
Part B: Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG001
Part B: Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG002
Part B: Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2
OG003
Part B: Daprodustat 2 mg Process 2
Secondary
Part B: T1/2 Following Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
ID
Title
Description
OG000
Part B: Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG001
Part B: Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG002
Part B: Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
Secondary
Part B: Apparent Clearance Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
ID
Title
Description
OG000
Part B: Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG001
Part B: Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG002
Part B: Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2
Secondary
Part B: Apparent Volume of Distribution Following Oral Administration of Daprodustat
Blood samples were collected at indicated time points to investigate the pharmacokinetics of daprodustat. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Pre-dose and 30 minutes, 1 Hour, 2 Hours, 2 Hours 30 Minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in Treatment Periods 1 and 2
ID
Title
Description
OG000
Part B: Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG001
Part B: Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG002
Part B: Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2
Time Frame
All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to 27 days in Part A and up to 18 days in Part B of the study.
Description
Safety Population was used to assess all-cause mortality, SAEs and non-SAEs which comprised of all randomized participants who have taken at least 1 dose of study intervention. AEs were presented part-wise and treatment-wise.
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
Part A: Daprodustat Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by reference Process 1 in each of the Treatment Periods 1, 2 and 3.
0
46
0
46
2
46
EG001
Part A: Daprodustat Process 2 Dissolution Profile 1
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 1 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
0
45
0
45
3
45
EG002
Part A: Daprodustat Process 2 Dissolution Profile 2
Participants received a single oral dose of daprodustat 4 mg tablets with dissolution profile 2 made by Process 2 in each of the Treatment Periods 1, 2 and 3.
0
43
0
43
0
43
EG003
Part B: Daprodustat 1 mg Process 1
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
0
39
0
39
1
39
EG004
Part B: Daprodustat 1 mg Process 2
Participants received a single oral dose of daprodustat 1 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
0
40
0
40
1
40
EG005
Part B: Daprodustat 2 mg Process 1
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
0
42
0
42
3
42
EG006
Part B: Daprodustat 2 mg Process 2
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
0
41
0
41
1
41
EG007
Part B: Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
0
42
1
42
3
42
EG008
Part B: Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
0
40
0
40
5
40
EG009
Part B: Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
0
42
0
42
6
42
EG010
Part B: Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
0
41
0
41
1
41
EG011
Part B: Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
0
40
0
40
5
40
EG012
Part B: Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
0
40
0
40
0
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG0030 events0 affected39 at risk
EG004
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
SARS-CoV-2 test positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0011 events1 affected45 at risk
EG0020 events0 affected43 at risk
EG0030 events0 affected39 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected42 at risk
EG0060 events0 affected41 at risk
EG0070 events0 affected42 at risk
EG0080 events0 affected40 at risk
EG0090 events0 affected42 at risk
EG0100 events0 affected41 at risk
EG0110 events0 affected40 at risk
EG0120 events0 affected40 at risk
Flatulence
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Feeling of body temperature change
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Feeling jittery
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Blood pressure increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Soft tissue swelling
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Tremor
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Vessel puncture site haemorrhage
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Vessel puncture site pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
COVID-19
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0011 events1 affected45 at risk
EG0020 events0 affected43 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected46 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected43 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.
Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.
Other
OG003
Part B: Daprodustat 2 mg Process 2
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG004
Part B: Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG005
Part B: Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG006
Part B: Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG007
Part B: Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG008
Part B: Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG009
Part B: Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Units
Counts
Participants
OG00039
OG00140
OG00242
OG00341
OG00442
OG00540
OG00642
OG00741
OG00840
OG00940
Title
Denominators
Categories
Title
Measurements
OG00036.97± 13.5
OG00138.02± 13.5
OG00283.27± 17.0
OG00379.08± 17.0
OG004132.9± 15.4
OG005134.2± 15.4
OG006249.5± 16.3
OG007241.5± 16.3
OG008292.8± 16.3
OG009278.5± 16.3
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
Geometric mean ratio
1.029
2-Sided
90
0.9770
1.083
Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90 percent (%) confidence interval (CI) of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
OG002
OG003
Geometric mean ratio
0.9496
2-Sided
90
0.8914
1.012
Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
OG004
OG005
Geometric mean ratio
1.010
2-Sided
90
0.9533
1.070
Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
OG006
OG007
Geometric mean ratio
0.9679
2-Sided
90
0.9115
1.028
Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
OG008
OG009
Geometric mean ratio
0.9511
2-Sided
90
0.8948
1.011
Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
Units
Counts
Participants
OG00035
OG00135
OG00234
Title
Denominators
Categories
Title
Measurements
OG00068.22± 28.7
OG00171.06± 28.7
OG00271.51± 28.7
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
Geometric mean ratio
1.042
2-Sided
90
0.9308
1.166
Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.
Other
OG000
OG002
Geometric mean ratio
1.048
2-Sided
90
0.9349
1.175
Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.
Other
OG003
Part B: Daprodustat 2 mg Process 2
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG004
Part B: Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG005
Part B: Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG006
Part B: Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG007
Part B: Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG008
Part B: Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG009
Part B: Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Units
Counts
Participants
OG00039
OG00140
OG00242
OG00341
OG00442
OG00540
OG00642
OG00741
OG00840
OG00940
Title
Denominators
Categories
Title
Measurements
OG00017.90± 22.2
OG00117.39± 22.2
OG00239.20± 28.8
OG00335.30± 28.8
OG00462.05± 30.9
OG00560.21± 30.9
OG006113.4± 26.7
OG007109.7± 26.7
OG008139.5± 27.6
OG009120.0± 27.6
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
Geometric mean ratio
0.9716
2-Sided
90
0.8936
1.056
Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
OG002
OG003
Geometric mean ratio
0.9006
2-Sided
90
0.8107
1.000
Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
OG004
OG005
Geometric mean ratio
0.9703
2-Sided
90
0.8665
1.087
Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
OG006
OG007
Geometric mean ratio
0.9675
2-Sided
90
0.8778
1.066
Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
OG008
OG009
Geometric mean ratio
0.8606
2-Sided
90
0.7770
0.9532
Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.
Equivalence
Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.
Units
Counts
Participants
OG00034
OG00135
OG00233
Title
Denominators
Categories
Title
Measurements
OG000159.9± 34.7
OG001162.5± 31.5
OG002161.5± 34.7
Units
Counts
Participants
OG00035
OG00135
OG00234
Title
Denominators
Categories
Title
Measurements
OG0002.500(0.500 to 8.00)
OG0012.000(1.00 to 6.00)
OG0022.000(1.00 to 4.00)
Units
Counts
Participants
OG00034
OG00135
OG00233
Title
Denominators
Categories
Title
Measurements
OG0001.797± 28.9
OG0011.910± 25.0
OG0021.932± 34.0
Units
Counts
Participants
OG00034
OG00135
OG00233
Title
Denominators
Categories
Title
Measurements
OG00025.02± 34.7
OG00124.61± 31.5
OG00224.77± 34.7
Units
Counts
Participants
OG00034
OG00135
OG00233
Title
Denominators
Categories
Title
Measurements
OG00064.87± 42.4
OG00167.81± 47.3
OG00269.05± 50.9
OG003
Part B: Daprodustat 2 mg Process 2
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG004
Part B: Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG005
Part B: Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG006
Part B: Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG007
Part B: Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG008
Part B: Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG009
Part B: Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Units
Counts
Participants
OG00036
OG00137
OG00242
OG00341
OG00440
OG00539
OG00642
OG00740
OG00839
OG00939
Title
Denominators
Categories
Title
Measurements
OG00037.71± 33.1
OG00138.81± 37.8
OG00284.36± 36.0
OG00378.59± 34.1
OG004135.5± 32.7
OG005135.2± 33.0
OG006250.4± 38.7
OG007246.0± 40.5
OG008295.8± 38.5
OG009282.7± 39.3
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG004
Part B: Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG005
Part B: Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG006
Part B: Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG007
Part B: Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG008
Part B: Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG009
Part B: Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Units
Counts
Participants
OG00039
OG00140
OG00242
OG00341
OG00442
OG00540
OG00642
OG00741
OG00840
OG00940
Title
Denominators
Categories
Title
Measurements
OG0002.000(0.500 to 4.00)
OG0012.000(0.517 to 4.00)
OG0022.250(1.00 to 4.00)
OG0032.000(0.500 to 4.00)
OG0042.000(1.00 to 4.00)
OG0052.000(0.500 to 4.00)
OG0062.000(0.500 to 4.00)
OG0071.000(0.500 to 4.00)
OG0082.000(1.00 to 4.00)
OG0092.000(0.500 to 6.00)
OG003
Part B: Daprodustat 2 mg Process 2
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG004
Part B: Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG005
Part B: Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG006
Part B: Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG007
Part B: Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG008
Part B: Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG009
Part B: Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Units
Counts
Participants
OG00036
OG00137
OG00242
OG00341
OG00440
OG00539
OG00642
OG00740
OG00839
OG00939
Title
Denominators
Categories
Title
Measurements
OG0001.162± 28.2
OG0011.163± 30.2
OG0021.545± 32.3
OG0031.489± 32.6
OG0041.814± 31.2
OG0051.775± 26.5
OG0061.852± 24.5
OG0071.920± 24.4
OG0081.997± 35.3
OG0092.136± 35.0
OG003
Part B: Daprodustat 2 mg Process 2
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG004
Part B: Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG005
Part B: Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG006
Part B: Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG007
Part B: Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG008
Part B: Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG009
Part B: Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
Units
Counts
Participants
OG00036
OG00137
OG00242
OG00341
OG00440
OG00539
OG00642
OG00740
OG00839
OG00939
Title
Denominators
Categories
Title
Measurements
OG00026.52± 33.1
OG00125.76± 37.8
OG00223.71± 36.0
OG00325.45± 34.1
OG00429.53± 32.7
OG00529.58± 33.0
OG00623.96± 38.7
OG00724.39± 40.5
OG00827.04± 38.5
OG00928.30± 39.3
OG003
Part B: Daprodustat 2 mg Process 2
Participants received a single oral dose of daprodustat 2 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG004
Part B: Daprodustat 4 mg Process 1
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG005
Part B: Daprodustat 4 mg Process 2
Participants received a single oral dose of daprodustat 4 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG006
Part B: Daprodustat 6 mg Process 1
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG007
Part B: Daprodustat 6 mg Process 2
Participants received a single oral dose of daprodustat 6 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.
OG008
Part B: Daprodustat 8 mg Process 1
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 1 in each of the Treatment Periods 1 and 2.
OG009
Part B: Daprodustat 8 mg Process 2
Participants received a single oral dose of daprodustat 8 mg tablets made by Process 2 in each of the Treatment Periods 1 and 2.