Status:
COMPLETED
A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
Lead Sponsor:
Gilead Sciences
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01847391
Start Date
May 1 2013
End Date
November 1 2013
Last Update
November 13 2013
Active Locations (1)
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1
Investigational Site
Madison, Wisconsin, United States, 53704