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

Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847391
• Other study ID #: GS-US-279-0102
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2013
• Last updated: November 11, 2013
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Investigational Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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, AUC0-8, T1/2, CL/F, VSS/F, and R.	Up to 65 days	No