Ischemic Heart Disease Clinical Trial
Official title:
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
Verified date | November 2013 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Investigational Site | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of GS-6615 | The primary outcome measure is the safety and tolerability of GS-6615 including neurological findings, adverse events, clinical laboratory tests, vital signs and ECG data (PR, RR, QRS, QT, and QTc [Fridericia] interval). | Up to 65 days | Yes |
Primary | Pharmacokinetic (PK) profile of GS-6615 | The primary outcome measure is the PK profile of GS-6615 which will be measured with Cmax, Tmax, AUCtau, AUC0-8, T1/2, CL/F, VSS/F, and R. | Up to 65 days | No |
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