Status:
COMPLETED
Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of single doses of midazolam on the plasma concentration of a single dose of moxidectin in healthy young adult subjects, and to assess the safety of...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
- WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle-stimulating hormone \[FSH\] ≥38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
- Healthy as determined by the investigator on the basis of screening evaluations.
- Exclusion criteria:
- Women of childbearing potential.
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00856362
Start Date
April 1 2009
End Date
September 1 2009
Last Update
September 16 2010
Active Locations (1)
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1
Berlin, Germany, 10117