Safety and Tolerability Study of Multiple Doses of PF-06305591

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06305591; Drug: Placebo

• Registration Number: NCT01776619
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-28
• Study Start: 2013-04
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Dose: Cohort 1	PF-06305591	-
Multiple Dose: Cohort 1	Placebo	-
Multiple Dose: Cohort 2	PF-06305591	-
Multiple Dose: Cohort 2	Placebo	-
Multiple Dose: Cohort 4	PF-06305591	-
Multiple Dose: Cohort 3	Placebo	-
Relative Bioavilability: Cohort 1	PF-06305591	-
Multiple Dose: Cohort 3	PF-06305591	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	14 days	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.
Area under the Concentration-Time Curve (AUC)	14 days	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)	14 days	AUC is a measure of the serum concentration of the drug over time interval. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)	14 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Brussels, Belgium