A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GS-6615
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Ischemic Heart Disease, Heart Disease
Eligibility 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
Sites / Locations
- Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo
Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo
Outcomes
Primary Outcome Measures
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).
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-∞, T1/2, CL/F, VSS/F, and R.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01847391
Brief Title
A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
Ischemic Heart Disease, Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo
Intervention Type
Drug
Intervention Name(s)
GS-6615
Intervention Description
GS-6615 tablet(s) administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet(s) to match GS-6615 administered orally once daily
Primary Outcome Measure Information:
Title
Safety and tolerability of GS-6615
Description
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).
Time Frame
Up to 65 days
Title
Pharmacokinetic (PK) profile of GS-6615
Description
The primary outcome measure is the PK profile of GS-6615 which will be measured with Cmax, Tmax, AUCtau, AUC0-∞, T1/2, CL/F, VSS/F, and R.
Time Frame
Up to 65 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Layug, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
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