Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00856362
First received: March 4, 2009
Last updated: September 15, 2010
Last verified: September 2010

March 4, 2009
September 15, 2010
April 2009
September 2009   (final data collection date for primary outcome measure)
Blood samples will be collected for determination of moxidectin and midazolam plasma concentrations [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00856362 on ClinicalTrials.gov Archive Site
Safety based on adverse event monitoring, physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs) and routine lab tests [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects
An Open-label, Single-Dose, 4-Period, Sequential Study to Determine the Effect of Moxidectin on CYP3A4 Activity in Healthy Subjects Using Midazolam as a Probe Substrate

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 co-administration of moxidectin and midazolam.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Moxidectin
  • Drug: Midazolam
Experimental: 1
Interventions:
  • Drug: Moxidectin
  • Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. 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.

  2. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
  3. Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion criteria:

  1. Women of childbearing potential.
  2. Presence or history of any disorder that may prevent the successful completion of the study.
  3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00856362
3110A1-1004
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP