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 |
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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