|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01103739 |
|
Date of registration:
|
26/02/2010 |
|
Primary sponsor: |
|
|
Public title:
|
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
|
|
Scientific 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 |
|
Date of first enrolment:
|
March 2010 |
|
Target sample size:
|
24 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01103739 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pfizer |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- young
- healthy
- male and female volunteers
Exclusion Criteria:
- Elderly
- Patients
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Pain
|
|
Intervention(s)
|
|
Drug: PF-04531083
|
|
Drug: simvastatin
|
|
Primary Outcome(s)
|
|
Pharmacokinetics of simvastatin acid. AUC, Cmax and half life.
[Time Frame: days 1 and 14 of study]
|
|
Pharmacokinetics of simvastatin. AUC, Cmax and half life.
[Time Frame: days 1 and 14 of study]
|
|
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]
|
|
Secondary Outcome(s)
|
|
safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events
[Time Frame: days 1 and 15 of the study]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|