Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Completed NCT02808312 Sponsor: Gilead Sciences Condition: Non-Alcoholic Fatty Liver Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial looked at how the body processes a drug called cilofexor in people with different levels of liver impairment. A total of 57 people were enrolled across five groups: 10 with mild liver impairment, 10 with moderate liver impairment, 10 with severe liver impairment, and comparison groups of people with normal liver function (17 in one group and 10 in another). All but one participant completed the trial — that one person was in the normal liver function comparison group for cohorts 1 and 2. The reported data shows that the trial measured how much of the drug entered the bloodstream and how quickly, using several standard drug-tracking measures. One key measure was how much drug was present in the blood over time (referred to as "AUC," or area under the curve — essentially a running total of drug exposure). The reported numbers show that people with mild liver impairment had a total drug exposure (AUClast) of around 5,382 units, compared to roughly 2,973 units in their matched healthy comparison group. For moderate liver impairment, the figure was around 8,224 units versus 2,757 units in the healthy comparison group. For severe liver impairment, it was around 6,534 units versus 960 units in that group's healthy comparators. The reported peak drug level in the blood (the highest concentration reached) was 994 ng/mL for the mild impairment group, 909 ng/mL for moderate, and 427 ng/mL for severe, compared to 604, 496, and 182 ng/mL respectively in each matched healthy group. The time it took to reach that peak level ranged from about 3 to 5 hours across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Completed

NCT02808312
Completed Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You may be eligible if you have mildly reduced liver function or normal liver function (Cohort 1).
  • If you have mild liver problems, your liver condition must have been measured as "mild" using a standard scoring system, and your condition must not have gotten worse in the 2 months before or during the initial check-up period (Cohort 1).
  • You may be eligible if you have moderately reduced liver function or normal liver function (Cohort 2).
  • If you have moderate liver problems, your liver condition must have been measured as "moderate" using a standard scoring system, and your condition must not have gotten worse in the 2 months before or during the initial check-up period (Cohort 2).
  • You may be eligible if you have severely reduced liver function or normal liver function (Cohort 3).
  • If you have severe liver problems, your liver condition must have been measured as "severe" using a standard scoring system, and your condition must not have gotten worse in the 2 months before or during the initial check-up period (Cohort 3).

Who may not be able to join:

  • People whose liver condition has been getting worse in the 2 months before or during the screening period may not be eligible.
  • There may be additional requirements or restrictions not listed here that could affect your eligibility (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
13 July 2016
Est. completion
16 October 2018

Where this trial is recruiting

🇳🇿 New Zealand 🇺🇸 United States

Primary endpoints

Pharmacokinetic (PK) Parameter: AUClast of Cilofexor; PK Parameter: AUCinf of Cilofexor; PK Parameter: Cmax of Cilofexor; PK Parameter: %AUCexp of Cilofexor; PK Parameter: Clast of Cilofexor; PK Parameter: Tmax of Cilofexor; PK Parameter: Tlast of Cilofexor; PK Parameter: λz of Cilofexor; PK Parameter: CL/F of Cilofexor; PK Parameter: Vz/F of Cilofexor; PK Parameter: t1/2 of Cilofexor

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov