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

Completed · Phase 1 · Has a placebo group

Conditions studied: PD Effects of GS-0976 (NDI-010976) on Fractional DNL

In brief

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.

Key facts

Study ID

NCT02876796

Run by

Gilead Sciences

People needed

30

Starts

2015-08-01

Expected to finish

2015-10-01

Last updated by the study team

2016-08-24

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Overweight and/or obese, but otherwise healthy males
• Weight ≥ 50.0 kg
• Body Mass Index (BMI): 25.0 - 32.0 kg/m\^2, inclusive

You may not qualify if…

• Intolerance to or malabsorption of fructose
• A history of clinically significant gastrointestinal disease and/or surgery, which would result in the subject's inability to absorb or metabolize the study drug (e.g., gastrectomy, gastric bypass, cholecystectomy).
• In the opinion of the Investigator, a history of clinically significant hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, metabolic , endocrine disorder (e.g., diabetes, thyroid disease), or cardiovascular disease.

Where it is running

• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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