Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674, and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 7/28/2016 |
| Start Date: | January 2016 |
| End Date: | July 2016 |
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674, and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
This study will evaluate the safety and tolerability of escalating single- and multiple-oral
doses of GS-9674, and characterize the single- and multiple-dose pharmacokinetics (PK) of
GS-9674. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants
will receive either GS-9674 or GS-9674 placebo.
Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative,
blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to
multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or
pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily
doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will
consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be
initiated in parallel with cohorts in Part A if the total dose under evaluation is at or
below a dose already evaluated.
This study is partially blinded (no one is blinded on Day -1).
doses of GS-9674, and characterize the single- and multiple-dose pharmacokinetics (PK) of
GS-9674. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants
will receive either GS-9674 or GS-9674 placebo.
Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative,
blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to
multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or
pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily
doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will
consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be
initiated in parallel with cohorts in Part A if the total dose under evaluation is at or
below a dose already evaluated.
This study is partially blinded (no one is blinded on Day -1).
Inclusion Criteria:
- Healthy male and non-pregnant, non-lactating female volunteers
- Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m^2
- Normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered
clinically insignificant by the investigator
- Normal renal function (estimated glomerular filtration rate calculated using the
Cockcroft-Gault equation ≥ 80 mL/min)
- No significant medical history, and in good general health as determined by the
investigator at screening evaluation performed no more than 28 days prior to the
scheduled first dose
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