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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00856362
First received: March 4, 2009
Last updated: September 15, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Healthy
Drug: Moxidectin
Drug: Midazolam
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Blood samples will be collected for determination of moxidectin and midazolam plasma concentrations [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety based on adverse event monitoring, physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs) and routine lab tests [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Moxidectin Drug: Midazolam

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856362

Locations
Germany
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
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00856362     History of Changes
Other Study ID Numbers: 3110A1-1004
Study First Received: March 4, 2009
Last Updated: September 15, 2010
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Healthy Subjects

Additional relevant MeSH terms:
Midazolam
Milbemycin
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents

ClinicalTrials.gov processed this record on April 21, 2014