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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Berlin, , 10117 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00856362
Pfizer
Completed
Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects

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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
Intervention Model: Single Group Assignment
Masking: None (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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00856362
3110A1-1004
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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