Safety and Tolerability Study of Multiple Doses of PF-06305591

Pfizer43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-06305591DRUG

14 day repeated 20mg BID doses

PlaceboDRUG

14 day repeated BID doses

PF-06305591DRUG

14 day repeated 80mg BID doses

Placebo

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Time frame: 14 days

Maximum Observed Plasma Concentration (Cmax)

Time frame: 14 days

Area under the Concentration-Time Curve (AUC)

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Time frame: 14 days

Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

AUC is a measure of the serum concentration of the drug over time interval. It is used to characterize drug absorption.

Time frame: 14 days

Data from ClinicalTrials.gov

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