PK in Healthy VolunteersPhase 1NCT01340157
Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions
A Phase 1 study testing Fexinidazole in people with PK in Healthy Volunteers, run by Drugs for Neglected Diseases at 1 site in France.
Trial summary
The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration. 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
- PK in Healthy Volunteers
- What is being tested?
- Fexinidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Apr 2011
- 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 m2) from 18 to 28 kg/m2 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 Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection,
- With any clinically significant abnormality following review of pre-study laboratory tests (aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and alkaline phosphatase (ALP) must be within normal ranges), vital signs, full physical examination and Electrocardiogram (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: Randomized, Open Study to Assess the Impact of Two Different Types of Food on the Relative Bioavailability of Fexinidazole Tablets After Single Oral Dose in Healthy Male Volunteers
The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.
- Conditions
- PK in Healthy Volunteers
- Being tested
- Fexinidazole
- Keywords
- Fexinidazole, Phase I, Bioavailability study, Food effect, Human African Trypanosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FexinidazoleDrug
Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Treatment A: 1200mg fexinidazole administered in fasting conditions by oral route Receives: Drug: Fexinidazole |
| Meal 1: Plumpy Nuts | Experimental | Treatment B: 1200mg fexinidazole administered in fed conditions (meal 1) by oral route Receives: Drug: Fexinidazole |
| Meal 2: Rice + beans | Experimental | Treatment B: 1200mg fexinidazole administered in fed conditions (meal 2) by oral route Receives: Drug: Fexinidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration measurement of fexinidazole, fexinidazole sulfoxide and sulfone metabolites after a single oral dose of fexinidazole (1200mg) administration and under different food intake conditions
Secondary outcomes (1)
Occurence of AEs
To assess safety and tolerability of fexinidazole tablets administered as single oral dose under fasting conditions and after two different meals in healthy male volunteers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PK in Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Lionel Hovsepian, MD, Principal investigator, SGS AsterAntoine Tarral, MD, Study director, Drugs for Neglected Diseases initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340157
- Sponsor's protocol ID
- DNDiFEX002
- Status last verified
- Apr 2011
- First submitted
- 14 Apr 2011
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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
- Randomized, Open Study to Assess the Impact of Two Different Types of Food on the Relative Bioavailability of Fexinidazole Tablets After Single Oral Dose in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01340157
- Acronym / sponsor ID
- DNDiFEX002
- Conditions
- PK in Healthy Volunteers
- Keywords
- Fexinidazole, Phase I, Bioavailability study, Food effect, Human African Trypanosomiasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Apr 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.
The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Drug: FexinidazoleTreatment A: 1200mg fexinidazole administered in fasting conditions by oral route |
| Meal 1: Plumpy Nuts | Experimental | Drug: FexinidazoleTreatment B: 1200mg fexinidazole administered in fed conditions (meal 1) by oral route |
| Meal 2: Rice + beans | Experimental | Drug: FexinidazoleTreatment B: 1200mg fexinidazole administered in fed conditions (meal 2) by oral route |
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 m2) from 18 to 28 kg/m2 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 Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection,
- With any clinically significant abnormality following review of pre-study laboratory tests (aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and alkaline phosphatase (ALP) must be within normal ranges), vital signs, full physical examination and Electrocardiogram (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 |
|---|---|---|
| FexinidazoleSingle oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet. | Drug | Fasting, Meal 1: Plumpy Nuts, Meal 2: Rice + beans |
Primary outcome
Plasma concentration measurement of fexinidazole, fexinidazole sulfoxide and sulfone metabolites after a single oral dose of fexinidazole (1200mg) administration and under different food intake conditions
1 secondary outcome
Occurence of AEs
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 31 Mar 2017.
- Sponsor websiteLink provided by the sponsor.
- Publication combining results of NCT00982904 \& NCT01483170Link provided by the sponsor.
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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
Antoine Tarral, MD study director
Drugs for Neglected Diseases initiative
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 Fexinidazole in people with PK in Healthy Volunteers, 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: finished, 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. 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?
Plasma concentration measurement of fexinidazole, fexinidazole sulfoxide and sulfone metabolites after a single oral dose of fexinidazole (1200mg) administration and under different food intake conditions. 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 31 Mar 2017.