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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Moxidectin; Drug: Midazolam

• Registration Number: NCT00856362
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-04
• Study First Posted: 2009-03-05
• Study Start: 2009-04
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-15
• Last Update Posted: 2010-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Moxidectin	-
1	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Blood samples will be collected for determination of moxidectin and midazolam plasma concentrations	4 months

Secondary Outcome Measures

Name	Time	Method
Safety based on adverse event monitoring, physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs) and routine lab tests	4 months