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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2015
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 19, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedAugust 24, 2016
August 1, 2016
1 month
August 19, 2016
August 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Change in fractional DNL (% new palmitate)
Predose and up to 10 hours postdose
Change in DNL over time following administration of GS-0976 and placebo
Predose and up to 10 hours postdose
Change from baseline over time in adiponectin
Baseline and up to 10 hours postdose
Percent change from baseline over time in adiponectin
Baseline and up to 10 hours postdose
Change from baseline over time in leptin
Baseline and up to 10 hours postdose
Percent change from baseline over time in leptin
Baseline and up to 10 hours postdose
Change from baseline over time in blood ketones
Baseline and up to 10 hours postdose
Percent change from baseline over time in blood ketones
Baseline and up to 10 hours postdose
Change from baseline over time in lipid profile
Baseline and up to 10 hours postdose
Percent change from baseline over time in lipid profile
Baseline and up to 10 hours postdose
Secondary Outcomes (5)
Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of GS-0976 and placebo
Up to 42 days
Percentage of participants experiencing abnormal clinical laboratory tests
Up to 42 days
Pharmacokinetics (PK) of GS-0976 and its metabolite: tmax
Baseline and up to 10 hours postdose
PK of GS-0976 and its metabolite: Cmax
Baseline and up to 10 hours postdose
PK of GS-0976 and its metabolite: AUC_0-t
Baseline and up to 10 hours postdose
Study Arms (3)
50 mg GS-0976 (Cohort 1)
EXPERIMENTALSequence 1: Period 1 (2 days): 50 mg (1 x 50 mg capsule) + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): placebo + IV infusion 1-13C acetate and fructose solution Sequence 2: Period 1 (2 days): placebo + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): 50 mg (1 x 50 mg capsule) + IV infusion 1-13C acetate and fructose solution
200 mg GS-0976 (Cohort 2)
EXPERIMENTALSequence 3: Period 1 (2 days): 200 mg (1 x 200 mg capsule) + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): placebo + IV infusion 1-13C acetate and fructose solution Sequence 4: Period 1 (2 days): placebo + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): 200 mg (1 x 200 mg capsule) + IV infusion 1-13C acetate and fructose solution
20 mg GS-0976 (Cohort 3)
EXPERIMENTALSequence 5: Period 1 (2 days): 20 mg (2 X 10 mg capsule) + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): placebo + IV infusion 1-13C acetate and fructose solution Sequence 6: Period 1 (2 days): placebo + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): 20 mg (2 X 10 mg capsule) + IV infusion 1-13C acetate and fructose solution
Interventions
Capsule(s) administered orally
Capsule(s) administered orally
10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours
Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Nimbus Apollocollaborator
Study Sites (1)
Unknown Facility
Phoenix, Arizona, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Rob Myers, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2016
First Posted
August 24, 2016
Study Start
August 1, 2015
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
August 24, 2016
Record last verified: 2016-08