---
title: Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
nct_id: NCT02808312
overall_status: COMPLETED
phase: PHASE1
sponsor: Gilead Sciences
study_type: INTERVENTIONAL
primary_condition: Nonalcoholic Steatohepatitis (NASH)
countries: United States, New Zealand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02808312.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02808312"
ct_last_update_post_date: 2021-01-07
last_seen_at: "2026-05-12T07:16:02.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function

**Official Title:** A Phase 1 Open-Label, Parallel-Group, Adaptive, Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9674 in Subjects With Normal and Impaired Hepatic Function

**NCT ID:** [NCT02808312](https://clinicaltrials.gov/study/NCT02808312)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 57
- **Lead Sponsor:** Gilead Sciences
- **Conditions:** Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
- **Start Date:** 2016-07-13
- **Completion Date:** 2018-10-16
- **CT.gov Last Update:** 2021-01-07

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **Cohort 1: Mild Hepatic Impairment** (EXPERIMENTAL) — Participants with mild hepatic impairment will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).
- **Cohort 1: Normal Hepatic Function** (EXPERIMENTAL) — 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).
- **Cohort 2: Moderate Hepatic Impairment** (EXPERIMENTAL) — Participants with moderate hepatic impairment will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).
- **Cohort 2: Normal Hepatic Function** (EXPERIMENTAL) — 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).
- **Cohort 3: Severe Hepatic Impairment** (EXPERIMENTAL) — Participants with severe hepatic impairment will receive a single oral dose of cilofexor 10 mg (1 x 10 mg tablet).
- **Cohort 3: Normal Hepatic Function** (EXPERIMENTAL) — 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).

## Interventions

- **Cilofexor** (DRUG) — Tablet(s) administered orally in a fed state on Day 1

## Primary Outcomes

- **Pharmacokinetic (PK) Parameter: AUClast of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — AUClast is defined as the concentration of drug from time zero to the last observable concentration.
- **PK Parameter: AUCinf of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — AUCinf is defined as the concentration of drug extrapolated to infinite time.
- **PK Parameter: Cmax of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — Cmax is defined as the maximum concentration of drug.
- **PK Parameter: %AUCexp of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.
- **PK Parameter: Clast of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — Clast is defined as the last observable concentration of drug.
- **PK Parameter: Tmax of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — Tmax is defined as the time (observed time point) of Cmax.
- **PK Parameter: Tlast of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — Tlast is defined as the time (observed time point) of Clast.
- **PK Parameter: λz of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
- **PK Parameter: CL/F of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — CL/F is defined as the apparent oral clearance following administration of the drug.
- **PK Parameter: Vz/F of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — Vz/F is defined as the apparent volume of distribution of the drug.
- **PK Parameter: t1/2 of Cilofexor** _(time frame: ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours postdose on Day 1)_ — t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

## Secondary Outcomes

- **Percentage of Participants Experiencing Treatment-Emergent Adverse Events** _(time frame: Day 1 up to Day 31)_
- **Percentage of Participants Who Experienced Graded Laboratory Abnormalities** _(time frame: Day 1 up to Day 31)_
- **Pharmacodynamic (PD) Parameter: Mean Day 1/ Day -1 Ratio of AUC2-12 for α-hydroxy-4-cholesten-3-one (C4)** _(time frame: 0.5 hour predose, ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, and 16 hours postdose on Day -1 and Day 1; 4.5 hours postdose on Day -1; 24, 48, 72, and 96 hours postdose on Day 1)_
- **PD Parameter: Mean Day 1/ Day -1 Ratio of Cmin for α-hydroxy-4-cholesten-3-one (C4)** _(time frame: 0.5 hour predose, ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, and 16 hours postdose on Day -1 and Day 1; 4.5 hours postdose on Day -1; 24, 48, 72, and 96 hours postdose on Day 1)_
- **PD Parameter: Mean Day 1/ Day -1 Ratio of AUC2-12 for Fibroblast Growth Factor 19 (FGF19)** _(time frame: 0.5 hour predose, ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, and 16 hours postdose on Day -1 and Day 1; 4.5 hours postdose on Day -1; 24, 48, 72, and 96 hours postdose on Day 1)_
- **PD Parameter: Mean Day 1/ Day -1 Ratio of Cmax for Fibroblast Growth Factor 19 (FGF19)** _(time frame: 0.5 hour predose, ≤ 5 minutes predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, and 16 hours postdose on Day -1 and Day 1; 4.5 hours postdose on Day -1; 24, 48, 72, and 96 hours postdose on Day 1)_

## Locations (5)

- Miami, Florida, United States
- Orlando, Florida, United States
- Knoxville, Tennessee, United States
- San Antonio, Texas, United States
- Auckland, New Zealand

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|miami|florida|united states` — added _(2026-05-12)_
- `locations.|orlando|florida|united states` — added _(2026-05-12)_
- `locations.|knoxville|tennessee|united states` — added _(2026-05-12)_
- `locations.|san antonio|texas|united states` — added _(2026-05-12)_
- `locations.|auckland||new zealand` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02808312*  
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