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

NCT ID: NCT01847391

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Heart Disease

Keywords

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Ischemic Heart Disease Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

GS-6615

Intervention Type DRUG

GS-6615 tablet(s) administered orally once daily

Placebo

Intervention Type DRUG

Placebo tablet(s) to match GS-6615 administered orally once daily

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

Group Type EXPERIMENTAL

GS-6615

Intervention Type DRUG

GS-6615 tablet(s) administered orally once daily

Placebo

Intervention Type DRUG

Placebo tablet(s) to match GS-6615 administered orally once daily

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

Group Type EXPERIMENTAL

GS-6615

Intervention Type DRUG

GS-6615 tablet(s) administered orally once daily

Placebo

Intervention Type DRUG

Placebo tablet(s) to match GS-6615 administered orally once daily

Interventions

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GS-6615

GS-6615 tablet(s) administered orally once daily

Intervention Type DRUG

Placebo

Placebo tablet(s) to match GS-6615 administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Layug, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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GS-US-279-0102

Identifier Type: -

Identifier Source: org_study_id