Study to Evaluate the Pharmacodynamic Effects of a Single Oral Dose of GS-0976 (NDI-010976) in Healthy Adult Subjects
NCT ID: NCT02876796
Last Updated: 2016-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2015-08-31
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
NCT00909766
Phase 1 Study of NGM313 in Healthy Adult Participants
NCT02708576
A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity
NCT04010786
Evaluate the Efficacy and Safety of NT-0796 in Participants With Obesity With or Without Type 2 Diabetes Mellitus
NCT07055516
Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity
NCT03661879
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
50 mg GS-0976 (Cohort 1)
Sequence 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
GS-0976
Capsule(s) administered orally
Placebo
Capsule(s) administered orally
1-13C acetate
10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours
Fructose solution
Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses
200 mg GS-0976 (Cohort 2)
Sequence 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
GS-0976
Capsule(s) administered orally
Placebo
Capsule(s) administered orally
1-13C acetate
10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours
Fructose solution
Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses
20 mg GS-0976 (Cohort 3)
Sequence 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
GS-0976
Capsule(s) administered orally
Placebo
Capsule(s) administered orally
1-13C acetate
10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours
Fructose solution
Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GS-0976
Capsule(s) administered orally
Placebo
Capsule(s) administered orally
1-13C acetate
10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours
Fructose solution
Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Weight ≥ 50.0 kg
* Body Mass Index (BMI): 25.0 - 32.0 kg/m\^2, inclusive
Exclusion Criteria
* 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.
18 Years
50 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nimbus Apollo
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rob Myers, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0976-103
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.