Safety and Tolerability Study of Multiple Doses of PF-06305591

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776619
• Other study ID #: B5281002
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2013
• Last updated: December 2, 2013
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium : Commission d'Ethique Biomédicale Hospitalo-Facultaire
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06305591
14 day repeated 20mg BID doses
• Placebo
14 day repeated BID doses
• PF-06305591
14 day repeated 80mg BID doses
• Placebo
14 day repeated BID doses
• PF-06305591
14 day repeated 40mg BID doses
• Placebo
14 day repeated BID doses
• PF-06305591
14 day repeated BID doses
• PF-06305591
relative bioavailability tablet vs. solution and food effect at 50mg dose

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Maximum Observed Plasma Concentration (Cmax)		14 days	No
Primary	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
Primary	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	No

External Links

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