Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Blood samples will be collected for determination of moxidectin and midazolam plasma concentrations [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- 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 |
Inclusion criteria:
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.
- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
- Healthy as determined by the investigator on the basis of screening evaluations.
Exclusion criteria:
- Women of childbearing potential.
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Contacts and Locations 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 May 23, 2013