Clinical trial NCT02876796: Study to Evaluate the Pharmacodynamic Effects of a Single Oral Dose of GS-0976 (NDI-010976) in Healthy Adult Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: PD Effects of GS-0976 (NDI-010976) on Fractional DNL
Keywords: fractional de novo lipogenesis
DNL
pharmacodynamic
pharmacokinetic
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Nimbus Apollo
First posted: 2016-08-24
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in fractional DNL (% new palmitate)
timeFrame: Predose and up to 10 hours postdose
measure: Change in DNL over time following administration of GS-0976 and placebo
timeFrame: Predose and up to 10 hours postdose
measure: Change from baseline over time in adiponectin
timeFrame: Baseline and up to 10 hours postdose
measure: Percent change from baseline over time in adiponectin
timeFrame: Baseline and up to 10 hours postdose
measure: Change from baseline over time in leptin
timeFrame: Baseline and up to 10 hours postdose
measure: Percent change from baseline over time in leptin
timeFrame: Baseline and up to 10 hours postdose
measure: Change from baseline over time in blood ketones
timeFrame: Baseline and up to 10 hours postdose
measure: Percent change from baseline over time in blood ketones
timeFrame: Baseline and up to 10 hours postdose
measure: Change from baseline over time in lipid profile
timeFrame: Baseline and up to 10 hours postdose
measure: Percent change from baseline over time in lipid profile
timeFrame: Baseline and up to 10 hours postdose
Secondary outcomes:
measure: Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of GS-0976 and placebo
timeFrame: Up to 42 days
measure: Percentage of participants experiencing abnormal clinical laboratory tests
timeFrame: Up to 42 days
measure: Pharmacokinetics (PK) of GS-0976 and its metabolite: tmax
timeFrame: Baseline and up to 10 hours postdose
measure: PK of GS-0976 and its metabolite: Cmax
timeFrame: Baseline and up to 10 hours postdose
measure: PK of GS-0976 and its metabolite: AUC_0-t
timeFrame: Baseline and up to 10 hours postdose
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
affiliation: Gilead Sciences
name: Rob Myers, MD
role: STUDY_DIRECTOR
References: