TrypanosomiasisPhase 1NCT01533961
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
A Phase 1 study testing SCYX-7158 in people with Trypanosomiasis and Trypanosomiasis, African, run by Drugs for Neglected Diseases at 2 sites in France.
Trial summary
This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158 in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy. 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, Trypanosomiasis, African, Protozoan Infections
- What is being tested?
- SCYX-7158
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2012to Mar 2015
- 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 5 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,
- Who previously received SCYX-7158,
- Who presented acute or chronic or history of symptoms of Gastro intestinal disturbances (GI) or on physical examination have evidence of any clinical signs of acute or chronic GI abnormality ( i.e hemorrhoids, GI bleeding…)
- With any clinically significant abnormality following review of pre-study laboratory tests (aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) 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,
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- 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
- 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
2 sites in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Sequential Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCYX-7158 After Single Oral Ascending Doses in Healthy Male Volunteers
This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158 in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy.
Read the detailed description
The present study is designed to obtain safety, tolerability and PK data after single oral administration of increasing doses of SCYX-7158 in healthy male sub-Saharan African subjects. This study will also assess the impact on the relative bioavailability of SCYX-7158 administered as a capsule after single oral dose administration.
The study will be divided in 3 different parts. Study Part I will be a randomized, double-blind, placebo-controlled, single ascending dose study with SCYX-7158 administered as a capsule.
A other part is scheduled to evaluate the impact of activated charcoal intake on the PK characteristics of SCYX-7158 and determine the most adapted treatment schedule for charcoal to enhance SCYX-7158 elimination while allowing a sustained drug exposure likely to be therapeutically active.
A last part is planned to evaluate the pharmacokinetics of a new formulation (tablet) of SCYX-7158 in healthy male volunteers
- Being tested
- SCYX-7158, Placebo
- Keywords
- neglected disease, africa, new drug, oral drug, parasite
- Medical subject headings
- Trypanosomiasis, Trypanosomiasis, African, Protozoan Infections, Parasitic Diseases, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCYX-7158Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SCYX-7158 | Experimental | In each dose group (8 subjects) , 6 Healthy Volunteers receive SCYX-7158 Receives: Drug: SCYX-7158 |
| Placebo of SCYX-7158 | Placebo comparator | In each dose group (8 subjects) , 2 Healthy Volunteers receive placebo of SCYX-7158 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of adverse events (AEs)
Monitoring for the occurrence of AEs. Changes in physical examination, vital signs (blood pressure and pulse rate), ECG, and clinical laboratory tests (biochemistry, hematology, and urinalysis).
Measured: 9 to 37 days, depending on the part of the study
Secondary outcomes (2)
Pharmacokinetic (blood concentration of SCYX-7158 and metabolite)
Measured: from pre-dose until 168 h post-dose.
Pharmacokinetic (urine concentration of SCYX-7158 and metabolite)
Measured: from pre-dose until 168 h post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrypanosomiasisStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Tarral, MD, Study director, Drugs for Neglected Diseases initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533961
- Sponsor's protocol ID
- DNDiOXA001
- Other IDs
- 2011-004639-30
- Status last verified
- Feb 2012
- First submitted
- 13 Feb 2012
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tarral A, Hovsepian L, Duvauchelle T, Donazzolo Y, Latreille M, Felices M, Gualano V, Delhomme S, Valverde Mordt O, Blesson S, Voiriot P, Strub-Wourgaft N. Determination of the Optimal Single Dose Treatment for Acoziborole, a Novel Drug for the Treatment of Human African Trypanosomiasis: First-in-Human Study. Clin Pharmacokinet. 2023 Mar;62(3):481-491. doi: 10.1007/s40262-023-01216-8. Epub 2023 Feb 10.
PubMed 36763327
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Sequential Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCYX-7158 After Single Oral Ascending Doses in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01533961
- Acronym / sponsor ID
- DNDiOXA001
- Keywords
- neglected disease, africa, new drug, oral drug, parasite
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Feb 2012 (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 study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158 in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy.
Detailed description
The present study is designed to obtain safety, tolerability and PK data after single oral administration of increasing doses of SCYX-7158 in healthy male sub-Saharan African subjects. This study will also assess the impact on the relative bioavailability of SCYX-7158 administered as a capsule after single oral dose administration.
The study will be divided in 3 different parts. Study Part I will be a randomized, double-blind, placebo-controlled, single ascending dose study with SCYX-7158 administered as a capsule.
A other part is scheduled to evaluate the impact of activated charcoal intake on the PK characteristics of SCYX-7158 and determine the most adapted treatment schedule for charcoal to enhance SCYX-7158 elimination while allowing a sustained drug exposure likely to be therapeutically active.
A last part is planned to evaluate the pharmacokinetics of a new formulation (tablet) of SCYX-7158 in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCYX-7158 | Experimental | Drug: SCYX-7158In each dose group (8 subjects) , 6 Healthy Volunteers receive SCYX-7158 |
| Placebo of SCYX-7158 | Placebo comparator | Drug: PlaceboIn each dose group (8 subjects) , 2 Healthy Volunteers receive placebo of SCYX-7158 |
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 (17 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,
- Who previously received SCYX-7158,
- Who presented acute or chronic or history of symptoms of Gastro intestinal disturbances (GI) or on physical examination have evidence of any clinical signs of acute or chronic GI abnormality ( i.e hemorrhoids, GI bleeding…)
- With any clinically significant abnormality following review of pre-study laboratory tests (aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) 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,
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 |
|---|---|---|
| SCYX-7158 | Drug | SCYX-7158 |
| Placebo | Drug | Placebo of SCYX-7158 |
Primary outcome
Occurence of adverse events (AEs)
Time frame: 9 to 37 days, depending on the part of the study
Monitoring for the occurrence of AEs. Changes in physical examination, vital signs (blood pressure and pulse rate), ECG, and clinical laboratory tests (biochemistry, hematology, and urinalysis).
2 secondary outcomes
Pharmacokinetic (blood concentration of SCYX-7158 and metabolite)
Time frame: from pre-dose until 168 h post-dose.
Pharmacokinetic (urine concentration of SCYX-7158 and metabolite)
Time frame: from pre-dose until 168 h post-dose.
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 18 Sep 2015.
- Derived from this study: PubMed 36763327Tarral A, Hovsepian L, Duvauchelle T, Donazzolo Y, Latreille M, Felices M, Gualano V, Delhomme S, Valverde Mordt O, Blesson S, Voiriot P, Strub-Wourgaft N. Determination of the Optimal Single Dose Treatment for Acoziborole, a Novel Drug for the Treatment of Human African Trypanosomiasis: First-in-Human Study. Clin Pharmacokinet. 2023 Mar;62(3):481-491. doi: 10.1007/s40262-023-01216-8. Epub 2023 Feb 10.
- Sponsor websiteLink 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.
Antoine Tarral, MD study director
Drugs for Neglected Diseases initiative
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCYX-7158 in people with Trypanosomiasis and Trypanosomiasis, African, run by Drugs for Neglected Diseases at 2 sites 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 17 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 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Occurence of adverse events (AEs) (time frame: 9 to 37 days, depending on the part of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01533961, which also lists 1 linked publication.
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 18 Sep 2015.