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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: placebo; Drug: GAP-134

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783341

3205K2-1001

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

GAP-134

Experimental group

Treatment:

Drug: GAP-134

placebo

Placebo Comparator group

Treatment:

Drug: placebo