Clinical Trials Logo
  1. Home
  2. Infection
  3. NCT00736697
  4. Details
NCT00736697 Clinical Trial

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

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00736697
Other study ID # 3110A1-1005
Secondary ID
Status Completed
Phase Phase 1
First received August 15, 2008
Last updated February 14, 2011
Start date November 2008
Est. completion date May 2009

Study information
Verified date February 2011
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• moxidectin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood samples 4 months No
Secondary Electrocardiograms 4 months No
See also
  Status Clinical Trial Phase
Completed NCT04529421 - Assocation Between In-person Instruction and COVID-19 Risk
Recruiting NCT04081792 - Optimal Antibiotics for Operated Diabetic Foot Infections N/A
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Recruiting NCT00342589 - New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Completed NCT03296423 - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly Phase 4
Withdrawn NCT04217252 - Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection N/A
Recruiting NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Withdrawn NCT02904434 - Gastrointestinal Implications of Voriconazole Exposure
Active, not recruiting NCT02768454 - Antimicrobials Stewardship by Pharmacist N/A
Completed NCT02219776 - Decreasing Infection In Arthroscopic Shoulder Surgery N/A
Completed NCT02210169 - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates N/A
Recruiting NCT02098226 - Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts N/A
Completed NCT01846832 - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection Phase 3
Terminated NCT01441206 - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants Phase 1
Completed NCT01434797 - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Completed NCT01159834 - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital) N/A