HealthyPhase 1NCT02051738
A Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Participants
A Phase 1 study testing Mebendazole - fasted state (Treatment A) and Mebendazole - fed state (Treatment B) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of the study is to evaluate the effect of food on the bioavailability (how much medication is in your blood) of mebendazole from a single 500 mg oral dose of a fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mebendazole - fasted state (Treatment A) and Mebendazole - fed state (Treatment B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Apr 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have signed an informed consent document
- Woman must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
- Woman must have a negative serum human chorionic gonadotropin pregnancy test at screening; and a negative urine pregnancy test on Day -1 of each treatment period
- Man must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day -1 of each Treatment Period as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or at admission to the study center on Day -1 of each Treatment Period as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, oral contraceptives and hormonal replacement therapy within 14 days before dosing in each treatment period
- Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates at screening and Day 1 of the each treatment period
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Subjects
The purpose of the study is to evaluate the effect of food on the bioavailability (how much medication is in your blood) of mebendazole from a single 500 mg oral dose of a fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.
Read the detailed description
This is an open-label (the participant and the study physician know what the participant is getting), randomized (like the flip of a coin), single-center, single-dose, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study) study in approximately 16 healthy adult participants. Participants will receive study medication under fed state first and later under fasted state or vice versa. The study consists of 3 phases: screening phase of approximately 3 weeks, an open-label treatment phase consisting of two 6-day treatment periods (Treatment period 1 and 2) with a 7- to 10 day washout between Day 1 of each treatment period, and a safety follow-up phase occurring 7 to 10 days after the last study-related procedure on Day 5 of Treatment Period 2. The study physician will check participant's general health during the study. Total duration of study for each participant will be approximately 48 days.
- Conditions
- Healthy
- Being tested
- Mebendazole - fasted state (Treatment A), Mebendazole - fed state (Treatment B)
- Keywords
- Healthy, Mebendazole, Fast-Disintegrating Chewable Formulation, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mebendazole - fasted state (Treatment A)Drug
Also called VERMOX
Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition.
Mebendazole - fed state (Treatment B)Drug
Also called VERMOX
Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | A single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fasted condition (Treatment A) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fed condition (Treatment B). Receives: Drug: Mebendazole - fasted state (Treatment A); Drug: Mebendazole - fed state (Treatment B) |
| Treatment Sequence BA | Experimental | A single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fed condition (Treatment B) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fasted condition (Treatment A). Receives: Drug: Mebendazole - fasted state (Treatment A); Drug: Mebendazole - fed state (Treatment B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of mebendazole in blood and urine under fed and fasted condition
Measured: Up to Day 5 of in each treatment period
Secondary outcomes (1)
Number of participants with adverse events
Measured: From screening up to 7 to 10 days after Day 5 of Treatment Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051738
- Sponsor's protocol ID
- CR103571
- Other IDs
- MEBENDAZOLGAI1002
- Status last verified
- Jun 2014
- First submitted
- 30 Jan 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, 2-Way Crossover Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02051738
- Acronym / sponsor ID
- CR103571
- Conditions
- Healthy
- Keywords
- Healthy, Mebendazole, Fast-Disintegrating Chewable Formulation, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Jan 2014 (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 purpose of the study is to evaluate the effect of food on the bioavailability (how much medication is in your blood) of mebendazole from a single 500 mg oral dose of a fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.
Detailed description
This is an open-label (the participant and the study physician know what the participant is getting), randomized (like the flip of a coin), single-center, single-dose, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study) study in approximately 16 healthy adult participants. Participants will receive study medication under fed state first and later under fasted state or vice versa. The study consists of 3 phases: screening phase of approximately 3 weeks, an open-label treatment phase consisting of two 6-day treatment periods (Treatment period 1 and 2) with a 7- to 10 day washout between Day 1 of each treatment period, and a safety follow-up phase occurring 7 to 10 days after the last study-related procedure on Day 5 of Treatment Period 2. The study physician will check participant's general health during the study. Total duration of study for each participant will be approximately 48 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: Mebendazole - fasted state (Treatment A), Drug: Mebendazole - fed state (Treatment B)A single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fasted condition (Treatment A) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fed condition (Treatment B). |
| Treatment Sequence BA | Experimental | Drug: Mebendazole - fasted state (Treatment A), Drug: Mebendazole - fed state (Treatment B)A single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fed condition (Treatment B) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fasted condition (Treatment A). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must have signed an informed consent document
- Woman must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
- Woman must have a negative serum human chorionic gonadotropin pregnancy test at screening; and a negative urine pregnancy test on Day -1 of each treatment period
- Man must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
Key exclusion criteria (6 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day -1 of each Treatment Period as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or at admission to the study center on Day -1 of each Treatment Period as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, oral contraceptives and hormonal replacement therapy within 14 days before dosing in each treatment period
- Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates at screening and Day 1 of the each treatment period
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 |
|---|---|---|
| Mebendazole - fasted state (Treatment A)Also: VERMOXParticipants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition. | Drug | Treatment Sequence AB, Treatment Sequence BA |
| Mebendazole - fed state (Treatment B)Also: VERMOXParticipants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition. | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Concentration of mebendazole in blood and urine under fed and fasted condition
Time frame: Up to Day 5 of in each treatment period
1 secondary outcome
Number of participants with adverse events
Time frame: From screening up to 7 to 10 days after Day 5 of Treatment Period 2
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 27 Jun 2014.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 Mebendazole - fasted state (Treatment A) and Mebendazole - fed state (Treatment B) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 5 inclusion and 6 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 27 Jun 2014. 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 Belgium. 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?
Concentration of mebendazole in blood and urine under fed and fasted condition (time frame: Up to Day 5 of in each treatment period). 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 27 Jun 2014.