A Single Dose Study Of PF-06291874 In Healthy Adult Subjects
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01499017
First received: November 14, 2011
Last updated: January 27, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-06291874 or placebo Drug: PF-06291874 or Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| 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 |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 [ Time Frame: 2 days/dose group ] [ Designated as safety issue: Yes ]
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] - Fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
- Maximum Observed Plasma Concentration (Cmax) fasted - 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
- Plasma Decay Half-Life (t1/2) fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
- Apparent Oral Clearance (CL/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
- Apparent Volume of Distribution (V/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | November 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort A
Each subjects in Cohort A will receive 3 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-4.
|
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.
Other Name: Not specified
|
|
Experimental: Cohort B
Each subjects in Cohort B will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state.
|
Drug: 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.
Other Name: Not Specified
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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).
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01499017 History of Changes |
| Other Study ID Numbers: | B4801001 |
| Study First Received: | November 14, 2011 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Single Ascending Dose Study in healthy subjects |
ClinicalTrials.gov processed this record on May 23, 2013