Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Normal Child-Pugh Score: N/A Subjects will receive a single 10 mg oral dose of seladelpar |
Drug: seladelpar
Oral single dose 10 mg
Other Names:
|
Experimental: Mild Impairment Child-Pugh Score: A (5 to 6 points) Subjects will receive a single 10 mg oral dose of seladelpar |
Drug: seladelpar
Oral single dose 10 mg
Other Names:
|
Experimental: Moderate Impairment Child-Pugh Score: B (7 to 9 points) Subjects will receive a single 10 mg oral dose of seladelpar |
Drug: seladelpar
Oral single dose 10 mg
Other Names:
|
Experimental: Severe Impairment Child-Pugh Score: C (10 to 15 points) Subjects will receive a single 10 mg oral dose of seladelpar |
Drug: seladelpar
Oral single dose 10 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum plasma concentration (Cmax) [5 days]
- Time to reach maximum concentration (Tmax) [5 days]
- Area under of the curve (AUC0-t and AUC0-∞) [5 days]
- Elimination of half-life (t1/2) [5 days]
- Apparent terminal elimination rate constant (λz) [5 days]
- Total body clearance (CL/F) [5 days]
- Volume of distribution (Vz/F) [5 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must have given written informed consent (signed and dated) and any authorizations required by local law.
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Willing to be confined to CRU for the entire duration required by the protocol.
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Male or female, between 18 and 80 years of age.
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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.
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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:
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Pregnant or lactating women.
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Treatment with another investigational drug or device within 30 days prior to study drug administration.
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Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
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Inability to swallow medication.
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Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.
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Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | DaVita Clinical Research | Lakewood | Colorado | United States | 80228 |
2 | Orlando Clinical Research Center | Orlando | Florida | United States | 32809 |
3 | DaVita Clinical Research | Minneapolis | Minnesota | United States | 55404 |
4 | Vrg & Noccr | Knoxville | Tennessee | United States | 37920 |
Sponsors and Collaborators
- CymaBay Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CB8025-11732