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

NCT00856362 | Completed Phase 1

• 1 other identifier: 3110A1-1004
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 co-administration of moxidectin and midazolam.

Conditions

Healthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Blood samples will be collected for determination of moxidectin and midazolam plasma concentrations

  4 months

Secondary Outcomes (1)

• Safety based on adverse event monitoring, physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs) and routine lab tests

  4 months

Study Arms (1)

1

EXPERIMENTAL

Drug: Moxidectin; Drug: Midazolam

Interventions

Moxidectin DRUG

1

Midazolam DRUG

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Berlin, 10117, Germany

Location

MeSH Terms

Interventions

moxidectin; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 16, 2010

Record last verified: 2010-09

Locations

DE (1)