HealthyPhase 1NCT02911298
Pharmaco-Scintigraphic Study to Evaluate the Release Profile of Metronidazole Benzoate Capsules
A Phase 1 study testing Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation and Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation in people with Healthy, run by Tillotts Pharma AG at 1 site in Switzerland.
Trial summary
This is a Phase I, open label, single-site trial to evaluate the in vivo release characteristics in the gastrointestinal tract of metronidazole benzoate capsules designed to disintegrate in the large intestine. This will be examined by means of metronidazole plasma levels and scintigraphic images in healthy subjects. 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?
- Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation and Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Nov 2016to 6 Mar 2017
- 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
- Healthy subjects, male or non-pregnant, non-lactating females, between 18 and 55 years old. Females of child bearing potential must have a negative urine pregnancy test prior to the intake of study drug, and must use a hormonal (oral, implantable or injectable) or a double barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal with as a minimum of one year since the last menstrual period).
- Ability of subject to participate fully in all aspects of this clinical trial.
- Voluntary signed informed consent must be obtained and documented.
- Accept not to use any kind of tobacco, including cigarettes nor E-Cigarettes or pipe smoking, nicotine replacements nor oral tobacco and not to consume any alcohol or drugs during screening, treatment and following two days.
Who cannot join
- Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
- Radiation exposure from clinical trials, including that from the present study and from diagnostic X-ray but excluding background radiation, exceeds 5 mSv in the last five years. No subject whose occupational exposure is monitored will participate in the study.
- Any nuclear medicine procedure prior to study day 1 that might interfere with the scintigraphic images that are acquired.
- Clinically significant deviation of biochemistry or haematology parameters from the normal range
- History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
- Clinically relevant cardiovascular, renal, hepatic, metabolic, autoimmune, pulmonary and particularly gastrointestinal diseases, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome (within the previous 12 months).
Show all 16Show fewer
- Acute diarrhoea or constipation in the 14 days before the predicted first study day. If screening occurs >14 days before first study day, this criterion is to be determined on the first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to defecate more frequently than every three days.
- History of adverse reaction or allergy to metronidazole or any study drug or formulation components/ingredients.
- Hypersensitivity to imidazole derivatives
- History of any malignancy removed or adequately treated.
- History of alcohol or drug abuse.
- Donation of blood (or plasma) within the previous three months and donation of Plasma the last 14 days.
- Over-the-counter (OTC) and prescription medication (including laxatives, vitamins and natural herbal remedies including St. John's Wort) between screening visit (visit 1) and completion of the study. Occasional paracetamol or acetyl-salicylic acid is permitted.
- Ingestion of grapefruit juice, coffee, caffeine containing beverages on treatment day.
- Failure to satisfy the Investigator to participate for any other reason.
- Known allergy to crustaceans (due to Chitosan)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Phase I Research Unit
Basel, Canton of Basel-City, 4031
About this study
Official title: An Open Label, Single-site Pharmaco-Scintigraphic Phase I - Study in Healthy Subjects to Evaluate the Gastrointestinal Transit and Release Profile of Radio-labelled Metronidazole Benzoate Capsules
This is a Phase I, open label, single-site trial to evaluate the in vivo release characteristics in the gastrointestinal tract of metronidazole benzoate capsules designed to disintegrate in the large intestine. This will be examined by means of metronidazole plasma levels and scintigraphic images in healthy subjects. Overall, nine subjects will be evaluated for each formulation prototype. Two formulation prototypes will be investigated. Each subject will receive one radio-labelled capsule only.
- Conditions
- Healthy
- Being tested
- Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation, Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulationDrug
Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulationDrug
| Study group | Role | What they receive |
|---|---|---|
| Mucoadhesive formulation | Experimental | A single dose of 100 mg Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation is administered to subject in fasted state Receives: Drug: Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation |
| Non-mucoadhesive formulation | Active comparator | A single dose of 100 mg Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation is administered to subject in fasted state Receives: Drug: Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scintigraphic analysis of time of capsule disintegration
Measured: 3 days
Scintigraphic analysis of location of capsule disintegration
Measured: 3 days
Transit time of the released granules after capsule disintegration
Measured: 3 days
Secondary outcomes (7)
Maximal plasma concentration (Cmax)
Measured: 3 days
Time to reach Cmax (Tmax)
Measured: 3 days
Area under the concentration-time curve
Measured: 3 days
Elimination rate constant (k)
Measured: 3 days
Apparent terminal half-live (t½)
Measured: 3 days
Lag time (t-lag)
Measured: 3 days
Time of first measurable concentration after dosing
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start25 Nov 2016
- Primary completion6 Mar 2017
- Study completion6 Mar 2017
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tillotts Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Swiss Commission for Technology and Innovation, University of Basel, University Hospital, Basel, Switzerland, SocraTec R&D GmbH
- Responsible party
- Sponsor
- Investigators
- Manuel Haschke, MD, Principal investigator, University Hospital Basel, Phase I Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911298
- Sponsor's protocol ID
- TP-CTI-01
- Status last verified
- Apr 2017
- First submitted
- 2 Sep 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-site Pharmaco-Scintigraphic Phase I - Study in Healthy Subjects to Evaluate the Gastrointestinal Transit and Release Profile of Radio-labelled Metronidazole Benzoate Capsules
- ClinicalTrials.gov ID
- NCT02911298
- Acronym / sponsor ID
- TP-CTI-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tillotts Pharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Swiss Commission for Technology and Innovation, University of Basel, University Hospital, Basel, Switzerland, SocraTec R&D GmbH
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 22 Sep 2016 (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 is a Phase I, open label, single-site trial to evaluate the in vivo release characteristics in the gastrointestinal tract of metronidazole benzoate capsules designed to disintegrate in the large intestine. This will be examined by means of metronidazole plasma levels and scintigraphic images in healthy subjects. Overall, nine subjects will be evaluated for each formulation prototype. Two formulation prototypes will be investigated. Each subject will receive one radio-labelled capsule only.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucoadhesive formulation | Experimental | Drug: Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulationA single dose of 100 mg Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation is administered to subject in fasted state |
| Non-mucoadhesive formulation | Active comparator | Drug: Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulationA single dose of 100 mg Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation is administered to subject in fasted state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects, male or non-pregnant, non-lactating females, between 18 and 55 years old. Females of child bearing potential must have a negative urine pregnancy test prior to the intake of study drug, and must use a hormonal (oral, implantable or injectable) or a double barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal with as a minimum of one year since the last menstrual period).
- Ability of subject to participate fully in all aspects of this clinical trial.
- Voluntary signed informed consent must be obtained and documented.
- Accept not to use any kind of tobacco, including cigarettes nor E-Cigarettes or pipe smoking, nicotine replacements nor oral tobacco and not to consume any alcohol or drugs during screening, treatment and following two days.
Key exclusion criteria (16 listed)
- Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
- Radiation exposure from clinical trials, including that from the present study and from diagnostic X-ray but excluding background radiation, exceeds 5 mSv in the last five years. No subject whose occupational exposure is monitored will participate in the study.
- Any nuclear medicine procedure prior to study day 1 that might interfere with the scintigraphic images that are acquired.
- Clinically significant deviation of biochemistry or haematology parameters from the normal range
- History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
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 |
|---|---|---|
| Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation | Drug | Mucoadhesive formulation |
| Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation | Drug | Non-mucoadhesive formulation |
Primary outcome
Scintigraphic analysis of time of capsule disintegration
Time frame: 3 days
Scintigraphic analysis of location of capsule disintegration
Time frame: 3 days
Transit time of the released granules after capsule disintegration
Time frame: 3 days
7 secondary outcomes
Maximal plasma concentration (Cmax)
Time frame: 3 days
Time to reach Cmax (Tmax)
Time frame: 3 days
Area under the concentration-time curve
Time frame: 3 days
Elimination rate constant (k)
Time frame: 3 days
Apparent terminal half-live (t½)
Time frame: 3 days
Lag time (t-lag)
Time frame: 3 days
Time of first measurable concentration after dosing
Time frame: 3 days
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 4 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Manuel Haschke, MD principal investigator
University Hospital Basel, Phase I Research Unit
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 Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation and Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation in people with Healthy, run by Tillotts Pharma AG at 1 site in Switzerland.
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 4 inclusion and 16 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 4 Apr 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 Switzerland. 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?
Scintigraphic analysis of time of capsule disintegration (time frame: 3 days). The study lists 3 primary outcomes in all. 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 4 Apr 2017.