Trypanosomiasis, AfricanPhase 1NCT01483170
Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food
A Phase 1 study testing Tablets Fexinidazole in people with Trypanosomiasis, African, run by Drugs for Neglected Diseases at 1 site in France.
Trial summary
This trial will study the tolerability and pharmacokinetic of fexinidazole using two different dosage regimen of repeated administrations. The drug is administered to human healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with a loading dose during 4 days. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Trypanosomiasis, African
- What is being tested?
- Tablets Fexinidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Feb 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy volunteers 18 to 45 years of age,
- All subjects to be of sub-Saharan African origins with both parents of sub-Saharan African origins too,
- Male subjects with a body mass index (BMI) calculated as weight in kg/(height in m)2 from 18 to 28 kg/m2 inclusive at screening,
- Able to communicate well with the Investigator and research staff and to comply with the requirements of the entire study,
- Provision of written informed consent to participate as shown by a signature on the volunteer consent form,
- Light smokers (less than 10 cigarettes per day) or subjects who are non-smokers. No smoking (or use of smoking substitute e.g. nicotine patch) is permitted from screening throughout the study,
- Normal arterial blood pressure (BP) and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator. These will be measured after resting for 5 min,
- Registered with the French Social Security in agreement with the French law on biomedical experimentation.
Who cannot join
- Who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV or HCV infection,
- With any clinically significant abnormality following review of pre-study laboratory tests(ASAT, ALAT and alkaline phosphatase (ALP) must be within normal ranges), vital signs, full physical examination and ECG,
- Who are within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health,
- Who forfeit their freedom by administrative or legal award or who were under guardianship,
- Unwilling to give their informed consent,
- Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 or anti-HCV antibodies
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- Who have a history of allergy, intolerance or photosensitivity to any drug,
- Who have a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug,
- Who are known or suspected alcohol or drug abusers (more than 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol),
- Who drink more than 8 cups daily of beverage containing caffeine,
- Who have a positive laboratory test for urine drug screening (opiates, cocaine,amphetamine, cannabis, benzodiazepines),
- Who have undergone surgery or have donated blood within 12 weeks prior to the start of the study,
- Who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 2 weeks prior to the first dose administration,
- Who have any clinical condition or prior therapy which, in the opinion of the Investigator, made the subject unsuitable for the study,
- Who participated to any clinical trial with an investigational drug in the past 3 months preceding study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo Controlled, Randomized Multiple Ascending Dose Study in Fed Conditions for Ten Days Dosing Regimen With a Loading Dose to Evaluate the Safety, the Tolerability and the Pharmacokinetics of Oral Fexinidazole in 36 Healthy Male Sub-Saharan Volunteers.
This trial will study the tolerability and pharmacokinetic of fexinidazole using two different dosage regimen of repeated administrations. The drug is administered to human healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with a loading dose during 4 days.
Read the detailed description
Objectives:
Primary Objectives: To assess safety and tolerability of two different fexinidazole dosing regimen, for 10 days repeated administration under fed conditions in healthy male sub-Saharan volunteers.
Secondary objectives: To validate the exposure to fexinidazole, M1 and M2 after different dosing regimens in fed conditions for 10 days in order to evaluate the more appropriate administration regimen for the pivotal phase II/III study.
Methodology/Study Design:
Two dose regimens consisting of repeated oral ascending dose (OAD) dosing in fed condition with two different ascending loading doses for 4 days followed by the same dose for 6 days will be evaluated. The study will be conducted in double-blind conditions for both the clinical and bioanalytical parts.
For each dosing regimen, subjects will reside at the clinical unit from the evening of Day -2 to the afternoon of Day 17 including an 8 days safety follow up (168 h post last dose).
- Conditions
- Trypanosomiasis, African
- Being tested
- Tablets Fexinidazole, Placebo
- Medical subject headings
- Trypanosomiasis, African
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablets FexinidazoleDrug
Administration of 3 or 4 tablets of 600mg per day during 4 days (loading dose) then administration of 2 tablets of 600mg for 6 days Dosing in fed condition.
PlaceboDrug
Placebo fexinidazole
| Study group | Role | What they receive |
|---|---|---|
| Fexinidazole | Experimental | Not described Receives: Drug: Tablets Fexinidazole |
| Placebo fexinidazole | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionFeb 2012
Why it stopped: poor tolerability at highest dose
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trypanosomiasis, AfricanStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel Hovsepian, MD, Principal investigator, SGS Aster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483170
- Sponsor's protocol ID
- DNDiFEX003
- Status last verified
- Mar 2017
- First submitted
- 29 Nov 2011
- Last updated
- 31 Mar 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo Controlled, Randomized Multiple Ascending Dose Study in Fed Conditions for Ten Days Dosing Regimen With a Loading Dose to Evaluate the Safety, the Tolerability and the Pharmacokinetics of Oral Fexinidazole in 36 Healthy Male Sub-Saharan Volunteers.
- ClinicalTrials.gov ID
- NCT01483170
- Acronym / sponsor ID
- DNDiFEX003
- Conditions
- Trypanosomiasis, African
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor tolerability at highest dose
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Dec 2011 (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.
This trial will study the tolerability and pharmacokinetic of fexinidazole using two different dosage regimen of repeated administrations. The drug is administered to human healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with a loading dose during 4 days.
Detailed description
Objectives:
Primary Objectives: To assess safety and tolerability of two different fexinidazole dosing regimen, for 10 days repeated administration under fed conditions in healthy male sub-Saharan volunteers.
Secondary objectives: To validate the exposure to fexinidazole, M1 and M2 after different dosing regimens in fed conditions for 10 days in order to evaluate the more appropriate administration regimen for the pivotal phase II/III study.
Methodology/Study Design:
Two dose regimens consisting of repeated oral ascending dose (OAD) dosing in fed condition with two different ascending loading doses for 4 days followed by the same dose for 6 days will be evaluated. The study will be conducted in double-blind conditions for both the clinical and bioanalytical parts.
For each dosing regimen, subjects will reside at the clinical unit from the evening of Day -2 to the afternoon of Day 17 including an 8 days safety follow up (168 h post last dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fexinidazole | Experimental | Drug: Tablets Fexinidazole |
| Placebo fexinidazole | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male healthy volunteers 18 to 45 years of age,
- All subjects to be of sub-Saharan African origins with both parents of sub-Saharan African origins too,
- Male subjects with a body mass index (BMI) calculated as weight in kg/(height in m)2 from 18 to 28 kg/m2 inclusive at screening,
- Able to communicate well with the Investigator and research staff and to comply with the requirements of the entire study,
- Provision of written informed consent to participate as shown by a signature on the volunteer consent form,
Key exclusion criteria (15 listed)
- Who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV or HCV infection,
- With any clinically significant abnormality following review of pre-study laboratory tests(ASAT, ALAT and alkaline phosphatase (ALP) must be within normal ranges), vital signs, full physical examination and ECG,
- Who are within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health,
- Who forfeit their freedom by administrative or legal award or who were under guardianship,
- Unwilling to give their informed consent,
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 |
|---|---|---|
| Tablets FexinidazoleAdministration of 3 or 4 tablets of 600mg per day during 4 days (loading dose) then administration of 2 tablets of 600mg for 6 days Dosing in fed condition. | Drug | Fexinidazole |
| PlaceboPlacebo fexinidazole | Drug | Placebo fexinidazole |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: poor tolerability at highest dose). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Sponsor websiteLink provided by the sponsor.
- Publication combining results of NCT00982904 + NCT01340157Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Lionel Hovsepian, MD principal investigator
SGS Aster
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 Tablets Fexinidazole in people with Trypanosomiasis, African, run by Drugs for Neglected Diseases 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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 31 Mar 2017. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: poor tolerability at highest dose). Results are not available in the source record.
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.
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 31 Mar 2017.