NCT02876796

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

A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Pharmacodynamic Effects of A Single Oral Dose of NDI-010976 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2016-08-24
• Last updated: 2016-08-24

Locations

1 site across 1 country: United States