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



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 65
Updated:10/3/2013
Start Date:May 2013
End Date:November 2013
Contact:Jonna Weston
Email:Jonna.Weston@gilead.com

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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


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.


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
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