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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014