Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-01-31

Brief Summary

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The study will assess the safety, tolerability and pharmacokinetics of single intravenous (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour infusion.

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Detailed Description

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Conditions

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Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GAP-134, IV and Oral

Experimental; Active Comparator; Placebo

Group Type OTHER

GAP-134

Intervention Type DRUG

atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO

Interventions

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GAP-134

atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Generally healthy men and women of nonchildbearing potential (WONCBP), aged 18 to 50 years.
* Body Mass Index (BMI) range of 18 to 30 kg/m2.
* Blood serum creatinine levels less than or equal to the upper limit of normal.

Exclusion Criteria

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any history of clinically important cardiac arrhythmias and familial history of long QT syndrome or unexpected cardiac death.
* History of drug and alcohol abuse, positive HIV, HCV, and/or HBs Ag test, and any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes