Safety and Tolerability Study of Multiple Doses of PF-06305591

A Double Blind (3rd Party Open) Randomized, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of Repeat Doses PF-06305591 Combined With a Cross-over Relative Bioavailability and Food Effect Evaluation After Single Dose of PF-06305591 in Healthy Young Subjects

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06305591; Drug: Placebo; Drug: PF-06305591; Drug: PF-06305591; Drug: PF-06305591; Drug: PF-06305591

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple Dose: Cohort 1	Drug: PF-06305591; 14 day repeated 20mg BID doses; Drug: Placebo; 14 day repeated BID doses; Drug: PF-06305591; 14 day repeated 80mg BID doses; Drug: PF-06305591; 14 day repeated 40mg BID doses; Drug: PF-06305591; 14 day repeated BID doses; Drug: PF-06305591; relative bioavailability tablet vs. solution and food effect at 50mg dose
Experimental: Multiple Dose: Cohort 2	Drug: PF-06305591; 14 day repeated 20mg BID doses; Drug: Placebo; 14 day repeated BID doses; Drug: PF-06305591; 14 day repeated 80mg BID doses; Drug: PF-06305591; 14 day repeated 40mg BID doses; Drug: PF-06305591; 14 day repeated BID doses; Drug: PF-06305591; relative bioavailability tablet vs. solution and food effect at 50mg dose
Experimental: Multiple Dose: Cohort 3	Drug: PF-06305591; 14 day repeated 20mg BID doses; Drug: Placebo; 14 day repeated BID doses; Drug: PF-06305591; 14 day repeated 80mg BID doses; Drug: PF-06305591; 14 day repeated 40mg BID doses; Drug: PF-06305591; 14 day repeated BID doses; Drug: PF-06305591; relative bioavailability tablet vs. solution and food effect at 50mg dose
Experimental: Multiple Dose: Cohort 4	Drug: PF-06305591; 14 day repeated 20mg BID doses; Drug: PF-06305591; 14 day repeated 80mg BID doses; Drug: PF-06305591; 14 day repeated 40mg BID doses; Drug: PF-06305591; 14 day repeated BID doses; Drug: PF-06305591; relative bioavailability tablet vs. solution and food effect at 50mg dose
Experimental: Relative Bioavilability: Cohort 1	Drug: PF-06305591; 14 day repeated 20mg BID doses; Drug: PF-06305591; 14 day repeated 80mg BID doses; Drug: PF-06305591; 14 day repeated 40mg BID doses; Drug: PF-06305591; 14 day repeated BID doses; Drug: PF-06305591; relative bioavailability tablet vs. solution and food effect at 50mg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)		14 days
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.	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.	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.	14 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 25, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Safety; tolerability; PK
• Other Study ID Numbers: B5281002