Single Ascending Dose Study of SRA-444 in Healthy Subjects

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a first-in-humans study of SRA-444. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR formulation) after administration of ascending single oral doses to healthy adult subjects.

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

Details

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

Criteria

Inclusion criteria:

• Healthy men or women of nonchildbearing potential aged 18 to 50 years,

• Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.

Exclusion criteria:

• Family history of sudden death and/or QT prolongation.

• An automatic ECG corrected QT (QTc) interval reading at screening >450 ms and >470 ms for male and female subjects, respectively.

• Sinus bradycardia at screening, defined as a resting heart rate ≤45 bpm. Resting supine blood pressure at screening <110 mm Hg (systolic) and/or <60 mm Hg (diastolic).