A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Drug: GS-6615
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Donation or loss of blood within 8 weeks and/or donation of plasma within 7 days History of drug or alcohol abuse Psychosocial or addictive disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo | Drug: GS-6615<br>* GS-6615 tablet(s) administered orally once daily<br>Drug: Placebo<br>* Placebo tablet(s) to match GS-6615 administered orally once daily<br>|
| Experimental: Cohort 2<br>Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo | Drug: GS-6615<br>* GS-6615 tablet(s) administered orally once daily<br>Drug: Placebo<br>* Placebo tablet(s) to match GS-6615 administered orally once daily<br>|
| Experimental: Cohort 3<br>Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo | Drug: GS-6615<br>* GS-6615 tablet(s) administered orally once daily<br>Drug: Placebo<br>* Placebo tablet(s) to match GS-6615 administered orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of GS-6615 | 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). | Up to 65 days | 
| Pharmacokinetic (PK) profile of GS-6615 | 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. | Up to 65 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Heart Disease, Heart Disease