Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers
This study has been completed.
Sponsor:
Taisho Pharmaceutical Co., Ltd.
Information provided by:
Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00756743
First received: September 19, 2008
Last updated: March 17, 2010
Last verified: January 2009
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Purpose
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-04802540 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | A Phase I Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04802540 After Multiple Oral Dose Administration To Healthy Adult Volunteers |
Further study details as provided by Taisho Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- Adverse events [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]
- Safety assessments: vital signs, ECG, physical examination, laboratory tests [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- No secondary outcomes measures. [ Time Frame: Timeframe N/A ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04802540 |
Drug: PF-04802540
Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo capsules q12 hours for 10 days
|
Detailed Description:
Evaluation of safety and pharmacokinetics
Eligibility| Ages Eligible for Study: | 21 Years to 54 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
- Body mass index in the range of 18 to 30 kg/m2 and body weight>45 kg.
- Healthy as determined by the investigator on the basis of screening evaluation.
Exclusion Criteria:
- Use of prescription or nonprescription drugs
- Any condition possibly affecting drug absorption
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756743
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756743
Locations
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 188770 | |
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Taisho Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00756743 History of Changes |
| Other Study ID Numbers: | B0911002 |
| Study First Received: | September 19, 2008 |
| Last Updated: | March 17, 2010 |
| Health Authority: | Singapore: Health Sciences Authority |
Keywords provided by Taisho Pharmaceutical Co., Ltd.:
|
PF-04802540 multiple dose safety study |
ClinicalTrials.gov processed this record on September 29, 2016