NCT00736697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 15, 2011

Status Verified

February 1, 2011

Enrollment Period

6 months

First QC Date

August 15, 2008

Last Update Submit

February 14, 2011

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

  • Blood samples

    4 months

Secondary Outcomes (1)

  • Electrocardiograms

    4 months

Study Arms (1)

1

EXPERIMENTAL
Drug: moxidectin

Interventions

moxidectinDRUG
1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Infections

Interventions

moxidectin

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 18, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

February 15, 2011

Record last verified: 2011-02

Locations

FR(1)