TP0502-B-Pharmaco-Scintigraphic-Study

Study Overview
=================
Brief 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 will be evaluated. The subjects will receive one [1] radio-labelled tablet after a high fat and a rich in calories breakfast.

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 Profile

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: TP05


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion 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 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation D<br>TP05 | Drug: TP05<br>* One radio-labelled tablet given to subject after a high fat and a rich in calories breakfast<br>* Other names: Mesalazine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tablet release |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Plasma Concentration (Cmax) |  | 3 days | 
| Time to reach Cmax (Tmax) |  | 3 days | 
| Area under the concentration time-curve |  | 3 days | 
| Elimination rate konstant (k) |  | 3 days | 
| Lag-time (t-lag) |  | 3 days |