MalariaPhase 1NCT00386503
Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions
A Phase 1 study testing Artesunate + Amodiaquine in people with Malaria, run by Sanofi at 1 site in France.
Trial 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™ Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Artesunate + Amodiaquine
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Dec 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Cross-Over Study, to Compare the Bioavailability of the Fixed Combination of Amodiaquine and Artesunate (COARSUCAM™) After Single Oral Administration Under Fed and Fasted Conditions in Healthy Subjects
- 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™
- Conditions
- Malaria
- Being tested
- Artesunate + Amodiaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate + AmodiaquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During all the study conduct
Tmax, Cmax, Truncated AUC(0-10d) for DSA
Measured: 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.
Measured: From the signature of the informed consent up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valerie Lameyre, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386503
- Sponsor's protocol ID
- ARAMF_L_01570
- Status last verified
- Dec 2008
- First submitted
- 10 Oct 2006
- Last updated
- 9 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Cross-Over Study, to Compare the Bioavailability of the Fixed Combination of Amodiaquine and Artesunate (COARSUCAM™) After Single Oral Administration Under Fed and Fasted Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00386503
- Acronym / sponsor ID
- ARAMF_L_01570
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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™
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artesunate + Amodiaquine | Drug | – |
Primary outcome
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
Time frame: During all the study conduct
Tmax, Cmax, Truncated AUC(0-10d) for DSA
Time frame: during the study conduct
1 secondary outcome
Safety and tolerability/Adverse events, physical examinations, vital signs including heart rate and blood pressure, ECG and laboratory parameters.
Time frame: From the signature of the informed consent up to the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Lameyre study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Artesunate + Amodiaquine in people with Malaria, run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: During all the study conduct). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2008.