Eligibility criteria
Condition
Chronic Pain
Sex
Females and Males
Age
18-45 years
Inclusion criteria
Show details
- young
- healthy
- male and female volunteers
Exclusion criteria
Show details
- Elderly
- Patients
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To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications
NCT01103739
Last updated on October 13, 2019
About this Study
The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.
NCT01103739
Pfizer
Completed
To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications | |||
| Official Title ICMJE | A Phase 1, Open Label, Fixed Sequence Study To Investigate The Effect Of Multiple Doses Of PF-04531083 On Simvastatin And Simvastatin Acid Pharmacokinetics Following Single Dose Of Simvastatin in Healthy Volunteers | |||
| Brief Summary | The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin. | |||
| Detailed Description | observational- quantify any effects of PF_04531083 on the PK of Simvastatin | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) | |||
| Condition ICMJE | Chronic Pain | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 24 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | May 2010 | |||
| Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Belgium | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01103739 | |||
| Other Study ID Numbers ICMJE | B1351007 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | June 2010 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
BY PHONE
Pfizer Clinical Trials Contact Center
1-800-718-1021