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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856362

Enrollment

Registered

2009-03-05

Start date

2009-04-30

Completion date

2009-09-30

Last updated

2010-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Subjects

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.

Interventions

DRUGMoxidectin

DRUGMidazolam

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026