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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01847391
First received: May 2, 2013
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Disease
Drug: GS-6615
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Safety and tolerability of GS-6615 [ Time Frame: Up to 65 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 65 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: May 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
Drug: GS-6615
GS-6615 tablet(s) administered orally once daily
Drug: Placebo
Placebo tablet(s) to match GS-6615 administered orally once daily
Experimental: Cohort 2
Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo
Drug: GS-6615
GS-6615 tablet(s) administered orally once daily
Drug: Placebo
Placebo tablet(s) to match GS-6615 administered orally once daily
Experimental: Cohort 3
Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo
Drug: GS-6615
GS-6615 tablet(s) administered orally once daily
Drug: Placebo
Placebo tablet(s) to match GS-6615 administered orally once daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01847391

Locations
United States, Wisconsin
Investigational Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Elizabeth Layug, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01847391     History of Changes
Other Study ID Numbers: GS-US-279-0102
Study First Received: May 2, 2013
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Ischemic Heart Disease
Heart Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014