Skip to main content
OpenTrials
Completed

NCT Number: NCT02876796

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GS-0976

Drug

Capsule(s) administered orally

Other names: NDI-010976

Placebo

Drug

Capsule(s) administered orally

1-13C acetate

Other

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

Fructose solution

Other

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

Primary outcomes

  1. Change in fractional DNL (% new palmitate)

    Time frame: Predose and up to 10 hours postdose

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

    Time frame: Predose and up to 10 hours postdose

  3. Change from baseline over time in adiponectin

    Time frame: Baseline and up to 10 hours postdose

  4. Percent change from baseline over time in adiponectin

    Time frame: Baseline and up to 10 hours postdose

  5. Change from baseline over time in leptin

    Time frame: Baseline and up to 10 hours postdose

  6. Percent change from baseline over time in leptin

    Time frame: Baseline and up to 10 hours postdose

  7. Change from baseline over time in blood ketones

    Time frame: Baseline and up to 10 hours postdose

  8. Percent change from baseline over time in blood ketones

    Time frame: Baseline and up to 10 hours postdose

  9. Change from baseline over time in lipid profile

    Time frame: Baseline and up to 10 hours postdose

  10. Percent change from baseline over time in lipid profile

    Time frame: Baseline and up to 10 hours postdose

Secondary outcomes

  1. Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of GS-0976 and placebo

    Time frame: Up to 42 days

  2. Percentage of participants experiencing abnormal clinical laboratory tests

    Time frame: Up to 42 days

  3. Pharmacokinetics (PK) of GS-0976 and its metabolite: tmax

    Time frame: Baseline and up to 10 hours postdose

    Tmax is defined as the time (observed time point) of Cmax.

  4. PK of GS-0976 and its metabolite: Cmax

    Time frame: Baseline and up to 10 hours postdose

    Cmax is defined as the maximum concentration of drug.

  5. PK of GS-0976 and its metabolite: AUC_0-t

    Time frame: Baseline and up to 10 hours postdose

    AUC_0-t is defined as the concentration of drug over time from time zero to time "t".

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Nimbus Apollo

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 24, 2016
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.