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Ulcerative ColitisPhase 1NCT02306785

TP0502-Pharmaco-Scintigraphic-Study and Amendment

A Phase 1 study testing TP05 Coating D, TP05 Coating E and TP05 Coating H in people with Ulcerative Colitis, run by Tillotts Pharma AG.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 and patients with mildly active UC. 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 D, TP05 Coating E and TP05 Coating H
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
Oct 2012to Jun 2013
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

  • Main criteria for inclusion of healthy subjects include:
  • 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.
  • Written informed consent must be obtained and documented.
  • Main criteria for inclusion of patients with mildly active Ulcerative Colitis (UC):
  • 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]).
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  • UC patients with occasional streaks of blood in the stool during the past week
  • UC patients with a stool frequency of 1-2/day > normal
  • UC patients whose activity of disease is considered mild by his/her treating gastroenterologist
  • Ability of patient to participate fully in all aspects of this clinical trial
  • Written informed consent must be obtained and documented

Who cannot join

  • Main criteria for exclusion of healthy subjects include:
  • Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
  • 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 (milli-Sievert) 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 abnormal biochemistry, haematology or urinalysis:
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  • White blood count <3 x 109/L and >8 x 109/L
  • Lymphocyte count < 0.85 x 109/L
  • Haemoglobin < 110g/L
  • Platelet count < 125 x 109/L or > 600 x 109/L
  • Alanine-Aminotransferase (ALT) or Aspartate-Aminotransferase (AST) > 2x upper limit of normal
  • Alkaline Phosphatase > 2x upper limit of normal
  • Serum Creatinine > upper limit of 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).
  • 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 open the bowels more frequently than every other day.
  • History of adverse reaction or allergy to aspirin, mesalazine or other salicylates.
  • Donation of blood within the previous three months.
  • Positive HBV-Antigen (Hepatitis-B), HCV-Antibody (Hepatitis-C) or HIV-antibody (Human Immunodeficiency Virus) result.
  • Over-the-counter (OTC) and prescription medication (including laxatives, vitamins and natural herbal remedies) between screening visit (visit 1) and completion of the study. Occasional paracetamol or acetyl-salicylic acid is permitted.
  • Failure to satisfy the Principal Investigator to participate for any other reason.
  • Main criteria for exclusion of UC patients include:
  • The patients will only be included in the study if they do not meet any of the following criteria:
  • Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
  • 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 5mSv in the last twelve months. No patient 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 urinalysis:
  • White blood count <3 x 109/L and >8 x 109/L
  • Lymphocyte count < 0.85 x 109/L
  • Haemoglobin < 110g/L
  • Platelet count < 125 x 109/L or > 600 x 109/L
  • ALT, AST, total Bilirubin or alkaline phosphatase > 2 times the upper limit of normal
  • Serum Creatinine > 1.5 times the upper limit of 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, peptic ulceration, gastrointestinal bleedings, Crohn's disease or Irritable Bowel Syndrome (within the previous 12 months) or any other disease which in the opinion of the investigator may interfere with the patient's ability to comply with the study procedures
  • Severe UC defined by the following criteria:
  • ≥ 6 bloody stools daily with one or more of the following
  • oral temperature > 37.8°C
  • pulse > 90/min
  • hemoglobin < 100 g/L
  • History of adverse reaction or allergy to aspirin, mesalazine or other salicylates.
  • Donation of blood within the previous three months.
  • Positive HBV-Antigen, HCV-Antibody or HIV-antibody result.
  • Unwilling to stop oral or rectal mesalazine treatment on the treatment day if on mesalazine treatment before enrolment
  • History of colectomy or partial colectomy
  • History of dysplasia in colonic biopsies
  • Failure to satisfy the Principal Investigator to participate for any other reason

About this study

Official title: An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects and Patients With Active Ulcerative Colitis With Radio-labelled TP05-tablets to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations (and Amendment)

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 and patients with mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of either formulation D or formulation E, respectively.

Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of this new third improved formulation H.

In order to keep the number of patients low, recruitment of patients will be stopped when obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will then be recruited to achieve a full set of participants (n=9 per Arm).

Being tested
TP05 Coating D, TP05 Coating E, TP05 Coating H
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 DDrug

    Also called Mesalazine

    One radio-labelled tablet given to subjects

  • TP05 Coating EDrug

    Also called Mesalazine

    One radio-labelled tablet given to subjects

  • TP05 Coating HDrug

    Also called Mesalazine

    One radio-labelled tablet given to subjects

Study groups in NCT02306785
Study groupRoleWhat they receive
Formulation DExperimentalTP05 Coating D
Receives: Drug: TP05 Coating D
Formulation EExperimentalTP05 Coating E
Receives: Drug: TP05 Coating E
Formulation HExperimentalTP05 Coating H
Receives: Drug: TP05 Coating H

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tablet release

    Measured: 3 days

Secondary outcomes (5)

  1. Maximal Plasma concentration (Cmax)

    Measured: 3 days

  2. Time to reach Cmax (Tmax)

    Measured: 3 days

  3. Area under the concentration time-curve

    Measured: 3 days

  4. Elimination rate konstant (k)

    Measured: 3 days

  5. 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.

  1. First posted3 Dec 2014 (estimated)
  2. Study startOct 2012
  3. Primary completionFeb 2013
  4. Study completionJun 2013

Resources

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02306785
Sponsor's protocol ID
TP0502 + A
Status last verified
Nov 2014
First submitted
15 Oct 2014
Last updated
3 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TP05 Coating D, TP05 Coating E and TP05 Coating H 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 11 inclusion and 48 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?

On the ClinicalTrials.gov record for NCT02306785.

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.

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