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
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01103739
First received: February 26, 2010
Last updated: June 3, 2010
Last verified: June 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain |
Drug: PF-04531083 Drug: simvastatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Chronic Pain
Drug Information available for:
Simvastatin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Pharmacokinetics of simvastatin. AUC, Cmax and half life. [ Time Frame: days 1 and 14 of study ] [ Designated as safety issue: No ]
- Pharmacokinetics of simvastatin acid. AUC, Cmax and half life. [ Time Frame: days 1 and 14 of study ] [ Designated as safety issue: No ]
- Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing [ Time Frame: days 2, 4, 7, 11 and 14 of the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events [ Time Frame: days 1 and 15 of the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | March 2010 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: cohort 1 |
Drug: PF-04531083
PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
Drug: simvastatin
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
|
| Experimental: cohort 2 |
Drug: PF-04531083
PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
Drug: simvastatin
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
|
Detailed Description:
observational- quantify any effects of PF_04531083 on the PK of Simvastatin
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- young
- healthy
- male and female volunteers
Exclusion Criteria:
- Elderly
- Patients
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01103739 History of Changes |
| Other Study ID Numbers: | B1351007 |
| Study First Received: | February 26, 2010 |
| Last Updated: | June 3, 2010 |
| Health Authority: | Belgium: Belgian Health Authority |
Keywords provided by Pfizer:
|
pharmacokinetics drug-drug interaction |
Additional relevant MeSH terms:
|
Simvastatin Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013