Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2012-10-31
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Formulation D
TP05 Coating D
TP05 Coating D
One radio-labelled tablet given to subjects
Formulation E
TP05 Coating E
TP05 Coating E
One radio-labelled tablet given to subjects
Formulation H
TP05 Coating H
TP05 Coating H
One radio-labelled tablet given to subjects
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TP05 Coating D
One radio-labelled tablet given to subjects
TP05 Coating E
One radio-labelled tablet given to subjects
TP05 Coating H
One radio-labelled tablet given to subjects
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. 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 \[defined as a minimum of one year since the last menstrual period\]).
2. Ability of subject to participate fully in all aspects of this clinical trial.
3. Written informed consent must be obtained and documented.
Main criteria for inclusion of patients with mildly active Ulcerative Colitis (UC):
1. 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 \[defined as a minimum of one year since the last menstrual period\]).
2. UC patients with occasional streaks of blood in the stool during the past week
3. UC patients with a stool frequency of 1-2/day \> normal
4. UC patients whose activity of disease is considered mild by his/her treating gastroenterologist
5. Ability of patient to participate fully in all aspects of this clinical trial
6. Written informed consent must be obtained and documented
Exclusion Criteria
1. Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
2. History of alcohol or drug abuse.
3. 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.
4. Any nuclear medicine procedure prior to study day 1 that might interfere with the scintigraphic images that are acquired.
5. 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
* 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
6. History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
7. 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).
8. 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.
9. History of adverse reaction or allergy to aspirin, mesalazine or other salicylates.
10. Donation of blood within the previous three months.
11. Positive HBV-Antigen (Hepatitis-B), HCV-Antibody (Hepatitis-C) or HIV-antibody (Human Immunodeficiency Virus) result.
12. 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.
13. 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:
1. Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
2. History of alcohol or drug abuse.
3. 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.
4. Any nuclear medicine procedure prior to study day 1 that might interfere with the scintigraphic images that are acquired.
5. 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
6. History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
7. 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
8. 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
9. History of adverse reaction or allergy to aspirin, mesalazine or other salicylates.
10. Donation of blood within the previous three months.
11. Positive HBV-Antigen, HCV-Antibody or HIV-antibody result.
12. Unwilling to stop oral or rectal mesalazine treatment on the treatment day if on mesalazine treatment before enrolment
13. History of colectomy or partial colectomy
14. History of dysplasia in colonic biopsies
15. Failure to satisfy the Principal Investigator to participate for any other reason
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tillotts Pharma AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TP0502 + A
Identifier Type: -
Identifier Source: org_study_id