A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PF-04634817

Study type

Interventional

Funder types

Industry

Identifiers

NCT01140672

B1261003

Details and patient eligibility

About

The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects. In additional, the plasma and urinary pharmacokinetics of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple doses of PF-04634817 on circulating monocytes will be explored.

Enrollment

48 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female (of non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
Nursing females;
Females of childbearing potential.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 6 patient groups

Cohort 1 (N=10)

Experimental group

Description:

Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active)

Treatment:

Drug: PF-04634817

Cohort 2 (N=10)

Experimental group

Description:

Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active)

Treatment:

Drug: PF-04634817

Cohort 3 (N=10)

Experimental group

Description:

Placebo-controlled, multiple doses of PF-04634817 at 30 mg per day for 14 days. (2 placebo: 8 active)

Treatment:

Drug: PF-04634817

Cohort 4 (N=10)

Experimental group

Description:

Placebo-controlled, multiple doses of PF-04634817 at 100 mg per day for 14 days. (2 placebo: 8 active)

Treatment:

Drug: PF-04634817

Cohort 5 (N=10)

Experimental group

Description:

Placebo-controlled, multiple doses of PF-04634817 at 300 mg per day for 14 days. (2 placebo: 8 active)

Treatment:

Drug: PF-04634817

Cohort 6 (N=10) Optional cohort

Experimental group

Description:

Placebo-controlled, multiple doses of PF-04634817 up to 300 mg per day for 14 days. (2 placebo: 8 active)

Treatment:

Drug: PF-04634817

Trial contacts and locations

1

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