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

NCT01847391 | Completed Phase 1

• 1 other identifier: GS-US-279-0102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Keywords

Ischemic Heart Disease; Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Cohort 1

EXPERIMENTAL

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; Drug: Placebo

Cohort 2

EXPERIMENTAL

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; Drug: Placebo

Cohort 3

EXPERIMENTAL

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; Drug: Placebo

Interventions

GS-6615 DRUG

GS-6615 tablet(s) administered orally once daily

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

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

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Investigational Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia; Heart Diseases

Interventions

eleclazine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases

Study Officials

• Elizabeth Layug, MD

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 6, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

US (1)