PD Effects of GS-0976 (NDI-010976) on Fractional DNLPhase 1NCT02876796
Study to Evaluate the Pharmacodynamic Effects of a Single Oral Dose of GS-0976 (NDI-010976) in Healthy Adult Subjects
A Phase 1 study testing GS-0976, 1-13C acetate and Fructose solution in people with PD Effects of GS-0976 (NDI-010976) on Fractional DNL, run by Gilead Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- PD Effects of GS-0976 (NDI-010976) on Fractional DNL
- What is being tested?
- GS-0976, 1-13C acetate and Fructose solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight and/or obese, but otherwise healthy males
- Weight ≥ 50.0 kg
- Body Mass Index (BMI): 25.0 - 32.0 kg/m^2, inclusive
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- GS-0976, Placebo, 1-13C acetate, Fructose solution
- Keywords
- fractional de novo lipogenesis, DNL, pharmacodynamic, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-0976Drug
Also called NDI-010976
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 solutionOther
Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses
| Study group | Role | What they receive |
|---|---|---|
| 50 mg GS-0976 (Cohort 1) | Experimental | 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 Receives: Drug: GS-0976; Drug: Placebo; Other: 1-13C acetate; Other: Fructose solution |
| 200 mg GS-0976 (Cohort 2) | Experimental | 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 Receives: Drug: GS-0976; Drug: Placebo; Other: 1-13C acetate; Other: Fructose solution |
| 20 mg GS-0976 (Cohort 3) | Experimental | 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 Receives: Drug: GS-0976; Drug: Placebo; Other: 1-13C acetate; Other: Fructose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fractional DNL (% new palmitate)
Measured: Predose and up to 10 hours postdose
Change in DNL over time following administration of GS-0976 and placebo
Measured: Predose and up to 10 hours postdose
Change from baseline over time in adiponectin
Measured: Baseline and up to 10 hours postdose
Percent change from baseline over time in adiponectin
Measured: Baseline and up to 10 hours postdose
Change from baseline over time in leptin
Measured: Baseline and up to 10 hours postdose
Percent change from baseline over time in leptin
Measured: Baseline and up to 10 hours postdose
Change from baseline over time in blood ketones
Measured: Baseline and up to 10 hours postdose
Percent change from baseline over time in blood ketones
Measured: Baseline and up to 10 hours postdose
Change from baseline over time in lipid profile
Measured: Baseline and up to 10 hours postdose
Percent change from baseline over time in lipid profile
Measured: 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
Measured: Up to 42 days
Percentage of participants experiencing abnormal clinical laboratory tests
Measured: Up to 42 days
Pharmacokinetics (PK) of GS-0976 and its metabolite: tmax
Tmax is defined as the time (observed time point) of Cmax.
Measured: Baseline and up to 10 hours postdose
PK of GS-0976 and its metabolite: Cmax
Cmax is defined as the maximum concentration of drug.
Measured: Baseline and up to 10 hours postdose
PK of GS-0976 and its metabolite: AUC_0-t
AUC_0-t is defined as the concentration of drug over time from time zero to time "t".
Measured: Baseline and up to 10 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startAug 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD Effects of GS-0976 (NDI-010976) on Fractional DNLStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nimbus Apollo
- Responsible party
- Sponsor
- Investigators
- Rob Myers, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876796
- Sponsor's protocol ID
- 0976-103
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02876796
- Acronym / sponsor ID
- 0976-103
- Keywords
- fractional de novo lipogenesis, DNL, pharmacodynamic, pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Nimbus Apollo
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50 mg GS-0976 (Cohort 1) | Experimental | Drug: GS-0976, Drug: Placebo, Other: 1-13C acetate, Other: Fructose solutionSequence 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) | Experimental | Drug: GS-0976, Drug: Placebo, Other: 1-13C acetate, Other: Fructose solutionSequence 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) | Experimental | Drug: GS-0976, Drug: Placebo, Other: 1-13C acetate, Other: Fructose solutionSequence 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overweight and/or obese, but otherwise healthy males
- Weight ≥ 50.0 kg
- Body Mass Index (BMI): 25.0 - 32.0 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-0976Also: NDI-010976Capsule(s) administered orally | Drug | 20 mg GS-0976 (Cohort 3), 200 mg GS-0976 (Cohort 2), 50 mg GS-0976 (Cohort 1) |
| PlaceboCapsule(s) administered orally | Drug | 20 mg GS-0976 (Cohort 3), 200 mg GS-0976 (Cohort 2), 50 mg GS-0976 (Cohort 1) |
| 1-13C acetate10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours | Other | 20 mg GS-0976 (Cohort 3), 200 mg GS-0976 (Cohort 2), 50 mg GS-0976 (Cohort 1) |
| Fructose solutionFructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses | Other | 20 mg GS-0976 (Cohort 3), 200 mg GS-0976 (Cohort 2), 50 mg GS-0976 (Cohort 1) |
Primary outcome
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
Time frame: Baseline and up to 10 hours postdose
Percent change from baseline over time in adiponectin
Time frame: Baseline and up to 10 hours postdose
Change from baseline over time in leptin
Time frame: Baseline and up to 10 hours postdose
Percent change from baseline over time in leptin
Time frame: Baseline and up to 10 hours postdose
Change from baseline over time in blood ketones
Time frame: Baseline and up to 10 hours postdose
Percent change from baseline over time in blood ketones
Time frame: Baseline and up to 10 hours postdose
Change from baseline over time in lipid profile
Time frame: Baseline and up to 10 hours postdose
Percent change from baseline over time in lipid profile
Time frame: Baseline and up to 10 hours postdose
5 secondary outcomes
Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of GS-0976 and placebo
Time frame: Up to 42 days
Percentage of participants experiencing abnormal clinical laboratory tests
Time frame: Up to 42 days
Pharmacokinetics (PK) of GS-0976 and its metabolite: tmax
Time frame: Baseline and up to 10 hours postdose
PK of GS-0976 and its metabolite: Cmax
Time frame: Baseline and up to 10 hours postdose
PK of GS-0976 and its metabolite: AUC_0-t
Time frame: Baseline and up to 10 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Myers, MD study director
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-0976, 1-13C acetate and Fructose solution in people with PD Effects of GS-0976 (NDI-010976) on Fractional DNL, run by Gilead Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fractional DNL (% new palmitate) (time frame: Predose and up to 10 hours postdose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.