A Study To Evaluate Whether Food Affects The Plasma Drug Levels Of A 35 mg Single Dose Of PF-04447943 Taken Orally In Healthy Adult Participants
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00886093
First received: April 21, 2009
Last updated: June 29, 2009
Last verified: June 2009
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Purpose
The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a 35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult volunteers will receive a single dose of the drug once when fasted and again when fed. The safety and tolerability of the drug will be monitored.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-04447943 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Phase 1, Open Label, Randomized, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On PF-04447943 Pharmacokinetics In Healthy Adult Subjects |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax). [ Time Frame: Up to 96 hours after drug administration ] [ Designated as safety issue: No ]
- Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, and adverse events. [ Time Frame: Up to 96 hours after drug administration ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- No secondary outcomes [ Time Frame: No secondary outcomes ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sequence 1 |
Drug: PF-04447943
35 mg tablet of PF-04447943 taken in the fed state in Period 1 followed a week later by administration of the same tablet and dose taken in the fasted state in Period 2
|
| Experimental: Sequence 2 |
Drug: PF-04447943
35 mg tablet of PF-04447943 taken in the fasted state in Period 1 followed a week later by administration of the same tablet and dose in the fed state in Period 2.
|
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, not of child bearing potential.
- Age 18-55 inclusive
- Total body weight >50 kg.
Exclusion Criteria:
- Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
- History of orthostatic blood pressure changes or orthostatic symptoms
- Greater than 7 drinks of alcohol per week for women and greater than 14 drinks per week for men
- Smoking more than 5 cigarettes per day
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00886093 History of Changes |
| Other Study ID Numbers: | B0401006 |
| Study First Received: | April 21, 2009 |
| Last Updated: | June 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
pharmacokinetics, single dose, crossover, fed vs fasted state |
ClinicalTrials.gov processed this record on May 21, 2013