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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Drug: GS-6615; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Up to 65 days

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 6, 2013

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 11, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Ischemic Heart Disease; Heart Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: GS-US-279-0102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No