NCT00386503

Brief Summary

  • Primary Objective: to evaluate the interaction with food after a single oral dose of a fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male subjects
  • Secondary Objective: to assess the clinical and biological safety and tolerability of Coarsucam™

Trial Health

80
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

December 9, 2008

Status Verified

December 1, 2008

Enrollment Period

6 months

First QC Date

October 10, 2006

Last Update Submit

December 8, 2008

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics/Time course of the plasma concentrations of AS, AQ & their pharmacologically active metabolites dihydroartemisinin (DHA) & desethylamodiaquine (DSA), used to determine:Tmax, Cmax, t1/2, AUC(0-t) & AUC(0-Inf) for AS, DHA & AQ

    During all the study conduct

  • Tmax, Cmax, Truncated AUC(0-10d) for DSA

    during the study conduct

Secondary Outcomes (1)

  • Safety and tolerability/Adverse events, physical examinations, vital signs including heart rate and blood pressure, ECG and laboratory parameters.

    From the signature of the informed consent up to the end of the study

Interventions

Artesunate + AmodiaquineDRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy Caucasian subjects
  • Weight between 50 kg and 90 kg. 18 ≤ Body Mass Index ≤ 28 kg/m2.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Malaria

Interventions

amodiaquine, artesunate drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Valerie Lameyre

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2006

Last Updated

December 9, 2008

Record last verified: 2008-12

Locations

FR(1)