Safety and Tolerability Study of Multiple Doses of PF-06305591

NCT01776619 | Completed Phase 1

• 1 other identifier: B5281002
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Safety; tolerability; PK

Outcome Measures

Primary Outcomes (4)

• 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

• Maximum Observed Plasma Concentration (Cmax)

  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

Study Arms (5)

Multiple Dose: Cohort 1

EXPERIMENTAL

Drug: PF-06305591; Drug: Placebo

Multiple Dose: Cohort 2

EXPERIMENTAL

Drug: PF-06305591; Drug: Placebo

Multiple Dose: Cohort 3

EXPERIMENTAL

Drug: PF-06305591; Drug: Placebo

Multiple Dose: Cohort 4

EXPERIMENTAL

Drug: PF-06305591

Relative Bioavilability: Cohort 1

EXPERIMENTAL

Drug: PF-06305591

Interventions

PF-06305591 DRUG

14 day repeated 20mg BID doses

Multiple Dose: Cohort 1

Placebo DRUG

14 day repeated BID doses

Multiple Dose: Cohort 1

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 28, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

BE (1)