TP0501 - Pharmaco-Scintigraphic-Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02306772
• Date of registration: 15/10/2014
• Prospective Registration: No
• Primary sponsor: Tillotts Pharma AG
• Public title: TP0501 - 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 Profiles of Two Different Formulations.
• Date of first enrolment: December 2011
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02306772
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel 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. Voluntarily signed informed consent must be obtained and documented.

Exclusion Criteria:

1. Participating in a clinical study involving investigational drugs or dosage forms
within the previous 2 months.

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 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.

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 urine analyses:

- White blood count < 3 x 109/L and > 8 x 109/L

- 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

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. History of adverse reaction or allergy to Mesalazine or other salicylates.

9. 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.

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) results.

12. 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.

13. Failure to satisfy the Principle 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 Coating A

Drug: TP05 Coating B

Primary Outcome(s)

Tablet release [Time Frame: 3 days]

Secondary Outcome(s)

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

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

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

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

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

Secondary ID(s)

TP0501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors