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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.