Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin

Wyeth

Status and phase: Completed; Phase 1

Conditions: Infection

Treatments: Drug: moxidectin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736697

3110A1-1005

Details and patient eligibility

About

The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on the concentrations of moxidectin measured in the blood after a single oral administration in healthy subjects.

Enrollment: 54 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Men or women of non childbearing potential aged 18 to 50 years inclusive at screening.
• Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion criteria

• Any clinical important deviation from normal limits in physical examination findings, vital sign measurements, electrocardiograms or clinical laboratory test results.
• Presence or history of any disorder that may prevent the successful completion of the study.

Trial design

54 participants in 1 patient group

1

Experimental group

Treatment:

Drug: moxidectin