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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00856362
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Moxidectin; Drug: Midazolam	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 38 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Moxidectin; Drug: Midazolam

Outcome Measures

Primary Outcome Measures

1. Blood samples will be collected for determination of moxidectin and midazolam plasma concentrations [4 months]

Secondary Outcome Measures

1. Safety based on adverse event monitoring, physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs) and routine lab tests [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

1. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Berlin		Germany	10117

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00856362
• Other Study ID Numbers: 3110A1-1004
• First Posted: Mar 5, 2009
• Last Update Posted: Sep 16, 2010
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: Healthy Subjects
• Additional relevant MeSH terms: Moxidectin; Midazolam

Study Results

No Results Posted as of Sep 16, 2010