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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Ischemic Heart Disease

Treatments: Drug: GS-6615; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01847391

GS-US-279-0102

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo

Treatment:

Drug: Placebo

Drug: GS-6615

Cohort 2

Experimental group

Description:

Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo

Treatment:

Drug: Placebo

Drug: GS-6615

Cohort 3

Experimental group

Description:

Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo

Treatment:

Drug: Placebo

Drug: GS-6615