Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Nonalcoholic Steatohepatitis (NASH); Primary Sclerosing Cholangitis (PSC)

Treatments: Drug: Cilofexor

Study type: Interventional

Funder types: Industry

Identifiers

NCT02808312

GS-US-402-3885

Details and patient eligibility

About

The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Cohort 1:

• Individuals with mildly impaired and normal hepatic function.
• Individuals with mild hepatic impairment must have a score of 5-6 on the Child-Pugh-Turcotte (CPT) classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 2:

• Individuals with moderately impaired and normal hepatic function.
• Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 3:

• Individuals with severely impaired and normal hepatic function.
• Individuals with severe hepatic impairment must have a score of 10-15 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 6 patient groups

Cohort 1: Mild Hepatic Impairment

Experimental group

Description:

Participants with mild hepatic impairment will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).

Treatment:

Drug: Cilofexor

Cohort 1: Normal Hepatic Function

Experimental group

Description:

Matched normal hepatic function participants to mild hepatic impairment participants will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).

Treatment:

Drug: Cilofexor

Cohort 2: Moderate Hepatic Impairment

Experimental group

Description:

Participants with moderate hepatic impairment will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).

Treatment:

Drug: Cilofexor

Cohort 2: Normal Hepatic Function

Experimental group

Description:

Matched normal hepatic function participants to moderate hepatic impairment participants will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).

Treatment:

Drug: Cilofexor

Cohort 3: Severe Hepatic Impairment

Experimental group

Description:

Participants with severe hepatic impairment will receive a single oral dose of cilofexor 10 mg (1 x 10 mg tablet).

Treatment:

Drug: Cilofexor

Cohort 3: Normal Hepatic Function

Experimental group

Description:

Matched normal hepatic function participants to severe hepatic impairment participants will receive a single oral dose of cilofexor 10 mg (1 x 10 mg tablet).

Treatment:

Drug: Cilofexor