Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02654002

Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674, and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics

Clinical Trial Summary

This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants will receive either cilofexor or cilofexor placebo.

Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative, blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose already evaluated.

This study is partially blinded (no one is blinded on Day -1).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • Non-alcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis (NASH)
Clinical Trial Details
NCT number NCT02654002
Study type Interventional
Source Gilead Sciences
Contact
Status Completed
Phase Phase 1
Start date January 20, 2016
Completion date July 14, 2016
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04880031 - A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) Phase 2
Suspended NCT04104321 - A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) Phase 3
Completed NCT02891408 - Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function Phase 1
Completed NCT04546984 - Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects Phase 1
Recruiting NCT05842512 - Study of ADI-PEG 20 Versus Placebo in Subjects With NASH Phase 2
Completed NCT02854605 - Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT06108219 - A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH) Phase 2
Recruiting NCT03572465 - Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
Active, not recruiting NCT05402371 - A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis Phase 2
Terminated NCT03823703 - Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT05117489 - A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH) Phase 1
Completed NCT04165343 - Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER
Recruiting NCT04913090 - A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects Phase 1
Recruiting NCT06024408 - A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk Factor Phase 1
Terminated NCT04004325 - A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis Phase 1/Phase 2
Completed NCT06037577 - Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects Phase 1
Active, not recruiting NCT05320146 - A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
Completed NCT01265498 - The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT) Phase 2
Terminated NCT00845845 - Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH) Phase 2
Terminated NCT04267393 - Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH) Phase 2