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Study to Evaluate the Pharmacodynamic Effects of a Single Oral Dose of GS-0976 (NDI-010976) in Healthy Adult Subjects

NCT02876796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-08-24

No results posted yet for this study

Summary

The primary objective of this study is to assess the pharmacodynamic (PD) effects of GS-0976 (NDI-010976) on fractional de novo lipogenesis (DNL) following a single oral dose administration in overweight and/or obese, but otherwise healthy, male adults.

Conditions

  • PD Effects of GS-0976 (NDI-010976) on Fractional DNL

Interventions

DRUG

GS-0976

Capsule(s) administered orally

DRUG

Placebo

Capsule(s) administered orally

OTHER

1-13C acetate

10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours

OTHER

Fructose solution

Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses

Sponsors & Collaborators

Principal Investigators

  • Rob Myers, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02876796 on ClinicalTrials.gov