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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences

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

• 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