TP0502-B-Pharmaco-Scintigraphic-Study
- Registration Number
- NCT02306798
- Lead Sponsor
- Tillotts Pharma AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- 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.
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Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
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History of alcohol or drug abuse.
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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.
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Any nuclear medicine procedure prior to study day 1 that might interfere with the scintigraphic images that are acquired.
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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
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History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
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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).
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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.
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History of adverse reaction or allergy to aspirin, mesalazine or other salicylates.
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Donation of blood within the previous three months.
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Positive HBV-Antigen (Hepatitis-B), HCV-Antibody (Hepatitis-C) or HIV-antibody (Human Immunodeficiency Virus) result.
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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.
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Failure to satisfy the Principal Investigator to participate for any other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Formulation D TP05 TP05
- Primary Outcome Measures
Name Time Method Tablet release 3 days
- Secondary Outcome Measures
Name Time Method Area under the concentration time-curve 3 days Maximal Plasma Concentration (Cmax) 3 days Time to reach Cmax (Tmax) 3 days Elimination rate konstant (k) 3 days Lag-time (t-lag) 3 days