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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00736697
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arm: 1
• Duration (Months): 5.9
• Patients Per Site Per Month: 9.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: moxidectin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: An Open-Label, Randomized, Single-Dose, Parallel-Group Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Moxidectin Administered Orally to Healthy Subjects
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: moxidectin

Outcome Measures

Primary Outcome Measures

1. Blood samples [4 months]

Secondary Outcome Measures

1. Electrocardiograms [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Poitiers		France	86000

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00736697
• Other Study ID Numbers: 3110A1-1005
• First Posted: Aug 18, 2008
• Last Update Posted: Feb 15, 2011
• Last Verified: Feb 1, 2011

• Additional relevant MeSH terms: Moxidectin

Study Results

No Results Posted as of Feb 15, 2011