TP0502-B-Pharmaco-Scintigraphic-Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02306798
• Date of registration: 15/10/2014
• Prospective Registration: No
• Primary sponsor: Tillotts Pharma AG
• Public title: TP0502-B-Pharmaco-Scintigraphic-Study
• Scientific 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 Profile
• Date of first enrolment: September 2013
• Target sample size: 9
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02306798
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Key inclusion & exclusion criteria

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.

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: TP05

Primary Outcome(s)

Tablet release [Time Frame: 3 days]

Secondary Outcome(s)

Area under the concentration time-curve [Time Frame: 3 days]

Lag-time (t-lag) [Time Frame: 3 days]

Time to reach Cmax (Tmax) [Time Frame: 3 days]

Elimination rate konstant (k) [Time Frame: 3 days]

Maximal Plasma Concentration (Cmax) [Time Frame: 3 days]

Secondary ID(s)

TP0502 - B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors