Safety and Tolerability Study of Multiple Doses of PF-06305591

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01776619
First received: January 23, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PF-06305591
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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.

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 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) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time interval. It is used to characterize drug absorption.


Enrollment: 43
Study Start Date: April 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multiple Dose: Cohort 1 Drug: PF-06305591
14 day repeated 20mg BID doses
Drug: Placebo
14 day repeated BID doses
Experimental: Multiple Dose: Cohort 2 Drug: PF-06305591
14 day repeated 80mg BID doses
Drug: Placebo
14 day repeated BID doses
Experimental: Multiple Dose: Cohort 3 Drug: PF-06305591
14 day repeated 40mg BID doses
Drug: Placebo
14 day repeated BID doses
Experimental: Multiple Dose: Cohort 4 Drug: PF-06305591
14 day repeated BID doses
Experimental: Relative Bioavilability: Cohort 1 Drug: PF-06305591
relative bioavailability tablet vs. solution and food effect at 50mg dose

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776619

Locations
Belgium
Pfizer Investigational Site
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01776619     History of Changes
Other Study ID Numbers: B5281002
Study First Received: January 23, 2013
Last Updated: December 2, 2013
Health Authority: Belgium : Commission d'Ethique Biomédicale Hospitalo-Facultaire

Keywords provided by Pfizer:
Safety
tolerability
PK

ClinicalTrials.gov processed this record on August 28, 2014