A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-04629991

Study type: Interventional

Funder types: Industry

Identifiers

NCT00797342

B0881001

Details and patient eligibility

About

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy non-smoking men and women
• body mass index 18-30 kg/m2

Exclusion criteria

• Women must not be able to have children
• no current infections

Trial design

27 participants in 3 patient groups

first of three dosing cohorts

Other group

Treatment:

Drug: PF-04629991

Drug: PF-04629991

Drug: PF-04629991

second of three dosing cohorts

Other group

Treatment:

Drug: PF-04629991

Drug: PF-04629991

Drug: PF-04629991

third of three dosing cohorts

Other group

Treatment:

Drug: PF-04629991

Drug: PF-04629991

Drug: PF-04629991