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

Phase 1

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Drug: GS-6615; Drug: Placebo

• Registration Number: NCT01847391
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-06
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	GS-6615	Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
Cohort 1	Placebo	Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
Cohort 2	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
Cohort 3	GS-6615	Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo
Cohort 3	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
Cohort 2	GS-6615	Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of GS-6615	Up to 65 days	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	Up to 65 days	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.

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Madison, Wisconsin, United States