Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Normal Healthy

Treatments: Drug: PF-05221304; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02871037

C1171001

Details and patient eligibility

About

The current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304.

Enrollment: 96 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and female of non-childbearing potential;
• Body Mass Index 17.5-30.5 kg/m2;
• Body weight >50 kg;

Exclusion criteria

• Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing

Trial design

96 participants in 7 patient groups, including a placebo group

Part 1_Cohort 1_Active

Experimental group

Description:

Single, escalating dose of PF-05221304

Treatment:

Drug: PF-05221304

Part 1_Cohort 1_Placebo

Placebo Comparator group

Description:

Single dose of Placebo

Treatment:

Other: Placebo

Part 1_Cohort 2_Active

Experimental group

Description:

Single, escalating dose of PF-05221304

Treatment:

Drug: PF-05221304

Part 1_Cohort 2_Placebo

Experimental group

Description:

Single dose of Placebo

Treatment:

Other: Placebo

Part 2_Active

Experimental group

Description:

Repeated, escalating doses of PF-05221304

Treatment:

Drug: PF-05221304

Part 2_Placebo

Placebo Comparator group

Description:

Repeated doses of placebo

Treatment:

Other: Placebo

Part 3

Experimental group

Description:

Single dose of PF-05221304 with and without food

Treatment:

Drug: PF-05221304