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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Midazolam; Drug: Moxidectin

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood samples will be collected for determination of moxidectin and midazolam plasma concentrations	4 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: March 4, 2009
• First Submitted That Met QC Criteria: March 4, 2009
• First Posted (Estimate): March 5, 2009

Study Record Updates

• Last Update Posted (Estimate): September 16, 2010
• Last Update Submitted That Met QC Criteria: September 15, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Midazolam; Moxidectin
• Other Study ID Numbers: 3110A1-1004