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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites38 target enrollmentApril 2009

ConditionsHealthy

InterventionsMoxidectin Midazolam

DrugsMoxidectin Midazolam

Overview

Phase: Phase 1
Intervention: Moxidectin
Conditions: Healthy
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 38
Primary Endpoint: Blood samples will be collected for determination of moxidectin and midazolam plasma concentrations
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

September 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

Intervention: Moxidectin

1

Intervention: Midazolam

Outcomes

Primary Outcomes

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

Time Frame: 4 months

Secondary Outcomes

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