Healthy VolunteersPhase 1NCT03717558
Bioavailability Pilot Study of Versus W0035 Versus Stromectol
A Phase 1 study testing ivermectin T1, ivermectin T2 and ivermectin T3 in people with Healthy Volunteers, run by Pierre Fabre Dermatology at 1 site in United Kingdom.
Trial summary
Ivermectin is prescribed for the treatment of helminthic infections sensitive to ivermectin. However, it is currently only available as a tablet formulation. W0035 is a powder for oral suspension of ivermectin developed by PIERRE FABRE DERMATOLOGIE intended to be administered to children for the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ivermectin T1, ivermectin T2 and ivermectin T3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2018to 30 Apr 2018
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18.5 ≤ BMI ≤ 30.0 kg/m².
- Non-smoker subject with a breath carbon monoxide reading of ≤10 ppm at screening.
- Agree to use effective contraception method
Who cannot join
- History of or current symptomatic orthostatic hypotension
- Hyper-eosinophilia or subject at risk of microfilaremic disease or clinical suspicion of intestinal helminth infection
- History of or current macroscopic or microscopic hematuria
- Positive serology for Hepatitis Bs antigen (HBs), Hepatitis C Virus (HCV) and HIV 1 and 2 antibodies.
- Organic disorder likely to modify, absorption, distribution or elimination of the medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Bioavailability Pilot Study of 3 W0035 Test Oral Suspensions (Ivermectin 1mg/mL) Versus Stromectol® (Ivermectin, 3 mg Tablet) After Single Oral Administration in Healthy Volunteers. Single Centre, Open Label, Crossover, Randomized, 5-period, 20-sequence, Partial Replicate, Single Dose Design
Ivermectin is prescribed for the treatment of helminthic infections sensitive to ivermectin. However, it is currently only available as a tablet formulation. W0035 is a powder for oral suspension of ivermectin developed by PIERRE FABRE DERMATOLOGIE intended to be administered to children for the treatment of helminthic infections sensitive to ivermectin and mentioned in the Summary of Product Characteristics (SmPC) of Stromectol.
PIERRE FABRE DERMATOLOGIE intends to carry out this pilot bioavailability study in order to define the most appropriate formulation to be used in the bioequivalence study.
- Conditions
- Healthy Volunteers
- Being tested
- ivermectin T1, ivermectin T2, ivermectin T3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivermectin T1Drug
Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol
ivermectin T2Drug
Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol
ivermectin T3Drug
Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol
| Study group | Role | What they receive |
|---|---|---|
| Stromectol R | Active comparator | Stromectol R = ivermectin 3mg (tablet) Receives: Drug: ivermectin T1; Drug: ivermectin T2; Drug: ivermectin T3 |
| ivermectin T1 | Experimental | T1= ivermectin low grade particle Size Distribution Receives: Drug: ivermectin T1; Drug: ivermectin T2; Drug: ivermectin T3 |
| ivermectin T2 | Experimental | T2= ivermectin medium grade particle Size Distribution Receives: Drug: ivermectin T1; Drug: ivermectin T2; Drug: ivermectin T3 |
| ivermectin T3 | Experimental | T= ivermectin high grade particle Size Distribution Receives: Drug: ivermectin T1; Drug: ivermectin T2; Drug: ivermectin T3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of ivermectin
At each period: 17 blood samples: T0 (Pre-dose), T0 +15min, T0 +30min, T0 +1h, T0+1h30min, T0 +2h, T0 +2h30, T0 +3h, T0 +3h30, T0 +4h, T0 +4h30, T0 +5h, T0 +6h, T0 +12h, T0 +24h, T0 +48h and T0 +72h
Measured: 5 periods of 3 days each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start30 Apr 2018 (estimated)
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open label, crossover, randomized, 5-period, 20-sequence, partial replicate, single dose design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermatology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karim Keddad, MD, Study director, Institut de Recherche Pierre Fabre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717558
- Sponsor's protocol ID
- W00035 PU 1 02
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Bioavailability Pilot Study of 3 W0035 Test Oral Suspensions (Ivermectin 1mg/mL) Versus Stromectol® (Ivermectin, 3 mg Tablet) After Single Oral Administration in Healthy Volunteers. Single Centre, Open Label, Crossover, Randomized, 5-period, 20-sequence, Partial Replicate, Single Dose Design
- ClinicalTrials.gov ID
- NCT03717558
- Acronym / sponsor ID
- W00035 PU 1 02
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pierre Fabre DermatologyIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2018 (estimated)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 24 Oct 2018 (actual)
- 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.
Ivermectin is prescribed for the treatment of helminthic infections sensitive to ivermectin. However, it is currently only available as a tablet formulation. W0035 is a powder for oral suspension of ivermectin developed by PIERRE FABRE DERMATOLOGIE intended to be administered to children for the treatment of helminthic infections sensitive to ivermectin and mentioned in the Summary of Product Characteristics (SmPC) of Stromectol.
PIERRE FABRE DERMATOLOGIE intends to carry out this pilot bioavailability study in order to define the most appropriate formulation to be used in the bioequivalence study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open label, crossover, randomized, 5-period, 20-sequence, partial replicate, single dose design
| Arm | Type | Receives |
|---|---|---|
| Stromectol R | Active comparator | Drug: ivermectin T1, Drug: ivermectin T2, Drug: ivermectin T3Stromectol R = ivermectin 3mg (tablet) |
| ivermectin T1 | Experimental | Drug: ivermectin T1, Drug: ivermectin T2, Drug: ivermectin T3T1= ivermectin low grade particle Size Distribution |
| ivermectin T2 | Experimental | Drug: ivermectin T1, Drug: ivermectin T2, Drug: ivermectin T3T2= ivermectin medium grade particle Size Distribution |
| ivermectin T3 | Experimental | Drug: ivermectin T1, Drug: ivermectin T2, Drug: ivermectin T3T= ivermectin high grade particle Size Distribution |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18.5 ≤ BMI ≤ 30.0 kg/m².
- Non-smoker subject with a breath carbon monoxide reading of ≤10 ppm at screening.
- Agree to use effective contraception method
Key exclusion criteria (5 listed)
- History of or current symptomatic orthostatic hypotension
- Hyper-eosinophilia or subject at risk of microfilaremic disease or clinical suspicion of intestinal helminth infection
- History of or current macroscopic or microscopic hematuria
- Positive serology for Hepatitis Bs antigen (HBs), Hepatitis C Virus (HCV) and HIV 1 and 2 antibodies.
- Organic disorder likely to modify, absorption, distribution or elimination of the medication.
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 |
|---|---|---|
| ivermectin T1Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol | Drug | Stromectol R, ivermectin T1, ivermectin T2, ivermectin T3 |
| ivermectin T2Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol | Drug | Stromectol R, ivermectin T1, ivermectin T2, ivermectin T3 |
| ivermectin T3Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol | Drug | Stromectol R, ivermectin T1, ivermectin T2, ivermectin T3 |
Primary outcome
Concentration of ivermectin
Time frame: 5 periods of 3 days each
At each period: 17 blood samples: T0 (Pre-dose), T0 +15min, T0 +30min, T0 +1h, T0+1h30min, T0 +2h, T0 +2h30, T0 +3h, T0 +3h30, T0 +4h, T0 +4h30, T0 +5h, T0 +6h, T0 +12h, T0 +24h, T0 +48h and T0 +72h
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy
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.
Karim Keddad, MD study director
Institut de Recherche Pierre Fabre
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 ivermectin T1, ivermectin T2 and ivermectin T3 in people with Healthy Volunteers, run by Pierre Fabre Dermatology at 1 site in United Kingdom.
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 5 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: withdrawn, as of the sponsor's last update on 24 Oct 2018. 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 United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Concentration of ivermectin (time frame: 5 periods of 3 days each). 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 24 Oct 2018.