A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01002963
First received: October 27, 2009
Last updated: October 22, 2010
Last verified: October 2010
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Purpose
The purpose of this study is to investigate safety and toleration of single oral doses as well as the time course of PF-04418948 concentration in the blood following dosing by oral solution.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-04418948 |
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), Randomized, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Doses Of PF-04418948 In Healthy Male Subjects |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2 [ Time Frame: 240 hours ] [ Designated as safety issue: No ]
- Safety: Adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood safety tests, fecal occult blood (FOB), cardiac troponin measurements, urine safety tests (KIM-1 measurements and creatinine). [ Time Frame: 240 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacodynamics: Emax (maximum observed increase in TNFα concentration from pre-dose level) TEmax (time to Emax), AUEClast, AUECt (where t will be a defined timepoint) and maximum n-fold increase in concentration from pre-dose level. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | September 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04418948 30 mg |
Drug: PF-04418948
solution, 30 mg, single
|
| Experimental: PF-04418948 100 mg |
Drug: PF-04418948
solution, 100 mg, single
|
| Experimental: PF-04418948 300 mg |
Drug: PF-04418948
solution, 300 mg, single
|
| Experimental: PF-04418948 1000 mg |
Drug: PF-04418948
solution, 1000 mg, single
|
| Experimental: PF-04418948 3000 mg |
Drug: PF-04418948
solution, 3000 mg, single
|
| Experimental: PF-04418948 4500 mg |
Drug: PF-04418948
solution, 4500 mg, single
|
| Experimental: PF-04418948 6000 mg |
Drug: PF-04418948
solution, 6000 mg, single
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male subjects 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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01002963 History of Changes |
| Other Study ID Numbers: | B0631001 |
| Study First Received: | October 27, 2009 |
| Last Updated: | October 22, 2010 |
| Health Authority: | Belgium: Federal Agenecy for Medicines and Health Products. |
ClinicalTrials.gov processed this record on May 21, 2013