Ulcerative ColitisPhase 1NCT02306772
TP0501 - Pharmaco-Scintigraphic-Study
A Phase 1 study testing TP05 Coating A and TP05 Coating B in people with Ulcerative Colitis, run by Tillotts Pharma AG.
Trial summary
This is a Phase I, open-label, single-site trial to evaluate the drug release, using Scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- TP05 Coating A and TP05 Coating B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Mar 2012
- 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 serum 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 [defined as a minimum of one year since the last menstrual period]).
- Ability of subject to participate fully in all aspects of this clinical trial.
- Voluntarily signed informed consent must be obtained and documented.
Who cannot join
- Participating in a clinical study involving investigational drugs or dosage forms within the previous 2 months.
- History of alcohol or drug abuse.
- 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 12 months or 10 mSv in the last 5 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 abnormal biochemistry, haematology or urine analyses:
- White blood count < 3 x 109/L and > 8 x 109/L
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- Lymphocyte count < 0.85 x 109/L
- Haemoglobin < 110 g/L
- Platelet count < 125 x 109/L or > 600 x 109/L
- Alanine-Aminotransferase (ALT) or Aspartate-Aminotransferase (AST) > 2x upper limit normal
- Alkaline Phosphatase > 2x upper limit normal
- Serum Creatinine > upper limit normal
- History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
- History of cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome (within the previous 12 months).
- History of adverse reaction or allergy to Mesalazine or other salicylates.
- 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 qa stool frequency of > 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day.
- Donation of blood within the previous three months.
- Positive HBV-Antigen (Hepatitis-B), HCV-Antibody (Hepatitis-C) or HIV-Antibody (Human Immunodeficiency Virus) results.
- Over-the-counter (OTC) and prescription medication (including laxatives, vitamin-pills and natural herbal remedies) between screening visit (visit 1) and completion of the study. Occasional paracetamol or acetyl-salicyl-acid is permitted.
- Failure to satisfy the Principle Investigator to participate for any other reason.
About this study
Official title: An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations.
This is a Phase I, open-label, single-site trial to evaluate the drug release, using Scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Eligible subjects will be assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive formulation B and the second 9 subjects will receive formulation A. The subjects will be treated once with the radio-labelled study medication.
- Conditions
- Ulcerative Colitis
- Being tested
- TP05 Coating A, TP05 Coating B
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP05 Coating ADrug
Also called Mesalazine
One radio-labelled tablet given to subjects
TP05 Coating BDrug
Also called Mesalazine
One radio-labelled tablet given to subjects
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | TP05 Coating A Receives: Drug: TP05 Coating A |
| Formulation B | Experimental | TP05 Coating B Receives: Drug: TP05 Coating B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tablet release
Measured: 3 days
Secondary outcomes (5)
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
Lag time (t-lag)
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 posted3 Dec 2014 (estimated)
- Study startDec 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306772
- Sponsor's protocol ID
- TP0501
- Status last verified
- Nov 2014
- First submitted
- 15 Oct 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations.
- ClinicalTrials.gov ID
- NCT02306772
- Acronym / sponsor ID
- TP0501
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tillotts Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Dec 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.
This is a Phase I, open-label, single-site trial to evaluate the drug release, using Scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Eligible subjects will be assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive formulation B and the second 9 subjects will receive formulation A. The subjects will be treated once with the radio-labelled study medication.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: TP05 Coating ATP05 Coating A |
| Formulation B | Experimental | Drug: TP05 Coating BTP05 Coating B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 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 serum 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 [defined as a minimum of one year since the last menstrual period]).
- Ability of subject to participate fully in all aspects of this clinical trial.
- Voluntarily signed informed consent must be obtained and documented.
Key exclusion criteria (20 listed)
- Participating in a clinical study involving investigational drugs or dosage forms within the previous 2 months.
- History of alcohol or drug abuse.
- 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 12 months or 10 mSv in the last 5 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 abnormal biochemistry, haematology or urine analyses:
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 |
|---|---|---|
| TP05 Coating AAlso: MesalazineOne radio-labelled tablet given to subjects | Drug | Formulation A |
| TP05 Coating BAlso: MesalazineOne radio-labelled tablet given to subjects | Drug | Formulation B |
Primary outcome
Tablet release
Time frame: 3 days
5 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
Lag time (t-lag)
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 3 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TP05 Coating A and TP05 Coating B in people with Ulcerative Colitis, run by Tillotts Pharma AG.
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 20 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Tablet release (time frame: 3 days). 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 3 Dec 2014.