Duvelisib in Hepatically Impaired Subjects Compared to He... | NCT02095587

Studies
Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

NCT02095587

Sponsor

SecuraBio

Status

Completed

Last Update Posted

Mar 17, 2021Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Hepatic Impairment

Interventions

IPI-145

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Mar 21, 2014

First Submission Date that Met QC Criteria

Mar 24, 2014

First Posted Date

Mar 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

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

Mar 15, 2021

Last Update Posted Date

Mar 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.

Detailed Description

This is a nonrandomized, open-label, parallel-group, single oral dose study in subjects with chronic hepatic impairment and matched (age, sex, weight, BMI) healthy subjects. Subjects will be enrolled into 1 of 3 groups based on hepatic impairment grade: mild, moderate and normal hepatic function. An optional severe hepatic impairment group will enroll based on data from the mild and moderate hepatic impairment groups in comparison to matched healthy group. All subjects will receive a single oral dose of IPI-145 25 mg.

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mild Hepatic Impairment	Experimental		Drug: IPI-145
Moderate Hepatic Impairment	Experimental		Drug: IPI-145
Healthy Subjects	Experimental		Drug: IPI-145
Severe Hepatic Impairment	Experimental	Optional arm based on results from Arms 1, 2, and 3	Drug: IPI-145

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IPI-145	Drug	25 mg single oral capsule	Healthy Subjects Mild Hepatic Impairment Moderate Hepatic Impairment Severe Hepatic Impairment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656	PK parameters (AUC, Cmax and t1/2) of IPI-145 and its metabolite, IPI-656 Plasma concentrations of IPI-145 and its metabolite, IPI-656	Open 72 hours

Secondary Outcomes

Measure	Description	Time Frame
Incidence of adverse events following administration of IPI-145	Safety Findings	10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men or women of nonchildbearing potential between 18-70 years of age
Body Mass Index (BMI): 18.0 - 38.0 kg/m2.
Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
Hepatic impairment subjects: confirmed hepatic impairment >1 year with etiology of chronic alcoholism, chronic viral hepatitis (B or C), nonalcoholic steatohepatitis, autoimmune hepatitis, Wilson disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia
Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

Women of childbearing potential
Hepatic impairment subjects: fluctuating or rapidly deteriorating hepatic function, acute hepatitis, variceal bleeding within 8 weeks of screening, a history of pancreatitis within 8 weeks of screening, evidence of hepatic encephalopathy > Grade 1, current unstable hematologic condition, and/or creatinine clearance < 60 mL/min
Healthy subjects: positive screening test for hepatitis B surface antigen, or hepatitis C antibody
ECG at screening or Day -1 showing QTcF ≥ 450 msec for healthy subjects or > 500 msec for hepatically impaired subjects
Evidence of clinically significant medical conditions
History of gastrointestinal disease or surgery that may affect drug absorption
Positive or indeterminate QuantiFERON-TB Gold test at screening
Any active infection at the time of screening or admission

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided