Single Ascending Dose Study of SRA-444 in Healthy Subjects

Wyeth

Status and phase

Completed

Phase 1

Conditions

Alzheimer Disease

Treatments

Drug: SRA-444

Study type

Interventional

Funder types

Industry

Identifiers

NCT00452504

3197A1-100

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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).