Safety and Tolerability Study of Multiple Doses of PF-06305591

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-06305591

Study type: Interventional

Funder types: Industry

Identifiers

NCT01776619

B5281002

Details and patient eligibility

About

Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.

Enrollment: 43 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects of non childbearing potential, between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

43 participants in 5 patient groups

Multiple Dose: Cohort 1

Experimental group

Treatment:

Drug: PF-06305591

Drug: Placebo

Multiple Dose: Cohort 2

Experimental group

Treatment:

Drug: PF-06305591

Drug: Placebo

Multiple Dose: Cohort 3

Experimental group

Treatment:

Drug: PF-06305591

Drug: Placebo

Multiple Dose: Cohort 4

Experimental group

Treatment:

Drug: PF-06305591

Relative Bioavilability: Cohort 1

Experimental group

Treatment:

Drug: PF-06305591