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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-02-28

Brief Summary

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This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of GAP 134 administered as 6-day continuous IV infusions to healthy subjects.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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GAP-134

Group Type EXPERIMENTAL

GAP-134

Intervention Type DRUG

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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GAP-134

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Men or women of non childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram (ECG).
4. Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24 mg/dL.)
5. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
3. Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the test article.
4. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
5. Any history of clinically important cardiac arrhythmias.
6. Familial history of long QT syndrome or unexpected cardiac death.
7. History of drug abuse within 1 year before study day 1.
8. History of alcoholism within 1 year before study day 1.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes