Status:
COMPLETED
TP0501 - 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 per protot...
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.
- Voluntarily signed informed consent must be obtained and documented.
Exclusion
- Participating in a clinical study involving investigational drugs or dosage forms within the previous 2 months.
- 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 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.
- 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 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
- 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).
- History of adverse reaction or allergy to Mesalazine or other salicylates.
- 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.
- Donation of blood within the previous three months.
- Positive HBV-Antigen (Hepatitis-B), HCV-Antibody (Hepatitis-C) or HIV-Antibody (Human Immunodeficiency Virus) results.
- 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.
- Failure to satisfy the Principle Investigator to participate for any other reason.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02306772
Start Date
December 1 2011
End Date
March 1 2012
Last Update
December 3 2014
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