A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- GS-6615
- Conditions
- Ischemic Heart Disease
- Sponsor
- Gilead Sciences
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of GS-6615
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2
- •Female subjects must be of non-childbearing potential as defined per the protocol
- •Male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception
- •Willing and able to comply with the requirements of the protocol and directions
- •Willing to avoid consumption of grapefruit, grapefruit juice and Seville oranges
- •Willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages
Exclusion Criteria
- •Ongoing or history of any medical or surgical condition that, in the judgment of the Investigator, might jeopardize the subject's safety or interfere with the study objectives
- •History of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures
- •Any abnormal ECG findings, abnormal laboratory value, or physical examination findings at Screening judged to be clinically significant
- •Any abnormal neurological examination findings at Screening that is judged as clinically significant
- •Hemoglobin \< 12 g/dL
- •Serology test positive for HIV, or hepatitis B or C
- •Positive urine drug test (including cotinine or ethanol)
- •Use of systemic prescription medications or over the counter (OTC) medication, including multivitamins, and dietary and herbal supplement
- •Use of any experimental or investigational drug or device within 30 days
- •Female subjects who are of childbearing potential, pregnant or lactating
Arms & Interventions
Cohort 1
Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
Intervention: GS-6615
Cohort 1
Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
Intervention: Placebo
Cohort 2
Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo
Intervention: GS-6615
Cohort 2
Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo
Intervention: Placebo
Cohort 3
Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo
Intervention: GS-6615
Cohort 3
Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and tolerability of GS-6615
Time Frame: Up to 65 days
The primary outcome measure is the safety and tolerability of GS-6615 including neurological findings, adverse events, clinical laboratory tests, vital signs and ECG data (PR, RR, QRS, QT, and QTc \[Fridericia\] interval).
Pharmacokinetic (PK) profile of GS-6615
Time Frame: Up to 65 days
The primary outcome measure is the PK profile of GS-6615 which will be measured with Cmax, Tmax, AUCtau, AUC0-∞, T1/2, CL/F, VSS/F, and R.