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Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

seladelpar

About this trial

This is an interventional treatment trial for Hepatic Impairment focused on measuring Hepatic Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Must have given written informed consent (signed and dated) and any authorizations required by local law.
Willing to be confined to CRU for the entire duration required by the protocol.
Male or female, between 18 and 80 years of age.
Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.
Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.

Exclusion Criteria:

Pregnant or lactating women.
Treatment with another investigational drug or device within 30 days prior to study drug administration.
Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
Inability to swallow medication.
Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.
Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.

Sites / Locations

DaVita Clinical Research
Orlando Clinical Research Center
DaVita Clinical Research
Vrg & Noccr

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Normal

Mild Impairment

Moderate Impairment

Severe Impairment

Arm Description

Child-Pugh Score: N/A Subjects will receive a single 10 mg oral dose of seladelpar

Child-Pugh Score: A (5 to 6 points) Subjects will receive a single 10 mg oral dose of seladelpar

Child-Pugh Score: B (7 to 9 points) Subjects will receive a single 10 mg oral dose of seladelpar

Child-Pugh Score: C (10 to 15 points) Subjects will receive a single 10 mg oral dose of seladelpar

Outcomes

Primary Outcome Measures

Maximum plasma concentration (Cmax)

Time to reach maximum concentration (Tmax)

Area under of the curve (AUC0-t and AUC0-∞)

Elimination of half-life (t1/2)

Apparent terminal elimination rate constant (λz)

Total body clearance (CL/F)

Volume of distribution (Vz/F)

Secondary Outcome Measures

Full Information

NCT ID

NCT03369002

First Posted

November 16, 2017

Last Updated

May 17, 2018

Sponsor

CymaBay Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03369002

Brief Title

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects

Official Title

A Phase 1, Open Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Seladelpar in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects With Normal Hepatic Function

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

November 27, 2017 (Actual)

Primary Completion Date

May 15, 2018 (Actual)

Study Completion Date

May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CymaBay Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

Keywords

Hepatic Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal

Arm Type

Experimental

Arm Description

Child-Pugh Score: N/A Subjects will receive a single 10 mg oral dose of seladelpar

Arm Title

Mild Impairment

Arm Type

Experimental

Arm Description

Child-Pugh Score: A (5 to 6 points) Subjects will receive a single 10 mg oral dose of seladelpar

Arm Title

Moderate Impairment

Arm Type

Experimental

Arm Description

Child-Pugh Score: B (7 to 9 points) Subjects will receive a single 10 mg oral dose of seladelpar

Arm Title

Severe Impairment

Arm Type

Experimental

Arm Description

Child-Pugh Score: C (10 to 15 points) Subjects will receive a single 10 mg oral dose of seladelpar

Intervention Type

Drug

Intervention Name(s)

seladelpar

Other Intervention Name(s)

MBX-8025

Intervention Description

Oral single dose 10 mg

Primary Outcome Measure Information:

Title

Maximum plasma concentration (Cmax)

Time Frame

5 days

Title

Time to reach maximum concentration (Tmax)

Time Frame

5 days

Title

Area under of the curve (AUC0-t and AUC0-∞)

Time Frame

5 days

Title

Elimination of half-life (t1/2)

Time Frame

5 days

Title

Apparent terminal elimination rate constant (λz)

Time Frame

5 days

Title

Total body clearance (CL/F)

Time Frame

5 days

Title

Volume of distribution (Vz/F)

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must have given written informed consent (signed and dated) and any authorizations required by local law. Willing to be confined to CRU for the entire duration required by the protocol. Male or female, between 18 and 80 years of age. Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study. Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol. Exclusion Criteria: Pregnant or lactating women. Treatment with another investigational drug or device within 30 days prior to study drug administration. Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day. Inability to swallow medication. Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1. Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.

Facility Information:

Facility Name

DaVita Clinical Research

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

DaVita Clinical Research

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

Vrg & Noccr

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects

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