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

Gilead Sciences30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

GS-0976DRUG

Capsule(s) administered orally

PlaceboDRUG

Capsule(s) administered orally

1-13C acetateOTHER

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

Fructose solution

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change in fractional DNL (% new palmitate)

Time frame: Predose and up to 10 hours postdose

Change in DNL over time following administration of GS-0976 and placebo

Time frame: Predose and up to 10 hours postdose

Change from baseline over time in adiponectin