A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00992342
First received: October 8, 2009
Last updated: March 17, 2010
Last verified: March 2010
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Purpose
The purpose of this study is to investigate safety and toleration of multiple oral doses as well as the time course of PF-03893787 concentration in the blood following dosing by oral solution.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-03893787 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03893787 In Healthy Subjects |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood (including creatine kinase) and urine safety tests and physical examination. [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic parameters: Cmax, Tmax, AUCτ, t½, accumulation ratio, [ Time Frame: 22 days ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-03893787 5 mg |
Drug: PF-03893787
oral solution, 5 mg, QD for 14 days
|
| Experimental: PF-03893787 15 mg |
Drug: PF-03893787
oral solution, 15 mg, QD for 14 days
|
| Experimental: PF-03893787 50 mg |
Drug: PF-03893787
oral solution, 50 mg, QD for 14 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male subjects and females of non-childbearing potential between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).
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 time of dosing).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00992342 History of Changes |
| Other Study ID Numbers: | B0281003 |
| Study First Received: | October 8, 2009 |
| Last Updated: | March 17, 2010 |
| Health Authority: | Belgium: FAMHP- Federal Agenecy for Medicines and Health Products. |
ClinicalTrials.gov processed this record on May 19, 2013