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

Completed · Phase 1

Conditions studied: Arrhythmia

In brief

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.

Key facts

Study ID

NCT00510029

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

72

Starts

2007-09-01

Expected to finish

2008-01-01

Last updated by the study team

2008-03-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.