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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Arrhythmia

Treatments: Drug: GAP-134

Study type: Interventional

Funder types: Industry

Identifiers

NCT00510029

3205K2-1000

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

72 participants in 1 patient group

GAP-134, IV and Oral

Other group

Description:

Experimental; Active Comparator; Placebo

Treatment:

Drug: GAP-134