Status:
COMPLETED
TP0502-B-Pharmaco-Scintigraphic-Study
Lead Sponsor:
Tillotts Pharma AG
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02306798
Start Date
September 1 2013
End Date
December 1 2013
Last Update
December 4 2014
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