A Single Dose Study Of PF-06291874 In Healthy Adult Subjects

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01499017
• Other study ID #: B4801001
• Status: Terminated
• Phase: Phase 1
• First received: November 14, 2011
• Last updated: January 27, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.

Description:

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers. The trial was terminated on Jan 9, 2012, due to undesired pharmacokinetic properties. The decision to terminate the trial was not based on any safety or efficacy concerns.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects of non childbearing potential.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06291874 or placebo
PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 3 mg to 100 mg. Correspondingly, placebo doses will be administered as suspension.
• PF-06291874 or Placebo
PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 300 mg to 650 mg. Correspondingly, placebo doses will be administered as suspension.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability data: number of subjects with adverse events and Laboratory Test Values of Potential Clinical Importance, Changes from baseline in pulse rate, blood pressure and Electrocardiogram (ECG) measurements over 48 hrs		2 days/dose group	Yes
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] - Fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs		2 days/dose group	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs		2 days/dose group	No
Primary	Maximum Observed Plasma Concentration (Cmax) fasted - 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs		2 days/dose group	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax) -fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs		2 days/dose group	No
Primary	Plasma Decay Half-Life (t1/2) fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs		2 days/dose group	No
Primary	Apparent Oral Clearance (CL/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs		2 days/dose group	No
Primary	Apparent Volume of Distribution (V/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs		2 days/dose group	No

External Links

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