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TP0502-Pharmaco-Scintigraphic-Study and Amendment

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TP05 Coating D
TP05 Coating E
TP05 Coating H
Sponsored by
Tillotts Pharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Main criteria for inclusion of healthy subjects include:

  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. Written informed consent must be obtained and documented.

Main criteria for inclusion of patients with mildly active Ulcerative Colitis (UC):

  1. 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. UC patients with occasional streaks of blood in the stool during the past week
  3. UC patients with a stool frequency of 1-2/day > normal
  4. UC patients whose activity of disease is considered mild by his/her treating gastroenterologist
  5. Ability of patient to participate fully in all aspects of this clinical trial
  6. Written informed consent must be obtained and documented

Exclusion Criteria:

Main criteria for exclusion of healthy subjects include:

  1. Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
  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 (milli-Sievert) in the last five 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 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
  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. 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.
  9. History of adverse reaction or allergy to aspirin, mesalazine or other salicylates.
  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) result.
  12. 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.
  13. Failure to satisfy the Principal Investigator to participate for any other reason.

Main criteria for exclusion of UC patients include:

The patients will only be included in the study if they do not meet any of the following criteria:

  1. Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
  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 5mSv in the last twelve months. No patient 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 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
    • ALT, AST, total Bilirubin or alkaline phosphatase > 2 times the upper limit of normal
    • Serum Creatinine > 1.5 times the upper limit of 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, peptic ulceration, gastrointestinal bleedings, Crohn's disease or Irritable Bowel Syndrome (within the previous 12 months) or any other disease which in the opinion of the investigator may interfere with the patient's ability to comply with the study procedures
  8. Severe UC defined by the following criteria:

    ≥ 6 bloody stools daily with one or more of the following

    • oral temperature > 37.8°C
    • pulse > 90/min
    • hemoglobin < 100 g/L
  9. History of adverse reaction or allergy to aspirin, mesalazine or other salicylates.
  10. Donation of blood within the previous three months.
  11. Positive HBV-Antigen, HCV-Antibody or HIV-antibody result.
  12. Unwilling to stop oral or rectal mesalazine treatment on the treatment day if on mesalazine treatment before enrolment
  13. History of colectomy or partial colectomy
  14. History of dysplasia in colonic biopsies
  15. Failure to satisfy the Principal Investigator to participate for any other reason

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Formulation D

    Formulation E

    Formulation H

    Arm Description

    TP05 Coating D

    TP05 Coating E

    TP05 Coating H

    Outcomes

    Primary Outcome Measures

    Tablet release

    Secondary Outcome Measures

    Maximal Plasma concentration (Cmax)
    Time to reach Cmax (Tmax)
    Area under the concentration time-curve
    Elimination rate konstant (k)
    Lag time (T-lag)

    Full Information

    First Posted
    October 15, 2014
    Last Updated
    December 1, 2014
    Sponsor
    Tillotts Pharma AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02306785
    Brief Title
    TP0502-Pharmaco-Scintigraphic-Study and Amendment
    Official Title
    An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects and Patients With Active Ulcerative Colitis With Radio-labelled TP05-tablets to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations (and Amendment)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tillotts Pharma AG

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 and patients with mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of either formulation D or formulation E, respectively. Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of this new third improved formulation H. In order to keep the number of patients low, recruitment of patients will be stopped when obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will then be recruited to achieve a full set of participants (n=9 per Arm).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Formulation D
    Arm Type
    Experimental
    Arm Description
    TP05 Coating D
    Arm Title
    Formulation E
    Arm Type
    Experimental
    Arm Description
    TP05 Coating E
    Arm Title
    Formulation H
    Arm Type
    Experimental
    Arm Description
    TP05 Coating H
    Intervention Type
    Drug
    Intervention Name(s)
    TP05 Coating D
    Other Intervention Name(s)
    Mesalazine
    Intervention Description
    One radio-labelled tablet given to subjects
    Intervention Type
    Drug
    Intervention Name(s)
    TP05 Coating E
    Other Intervention Name(s)
    Mesalazine
    Intervention Description
    One radio-labelled tablet given to subjects
    Intervention Type
    Drug
    Intervention Name(s)
    TP05 Coating H
    Other Intervention Name(s)
    Mesalazine
    Intervention Description
    One radio-labelled tablet given to subjects
    Primary Outcome Measure Information:
    Title
    Tablet release
    Time Frame
    3 days
    Secondary Outcome Measure Information:
    Title
    Maximal Plasma concentration (Cmax)
    Time Frame
    3 days
    Title
    Time to reach Cmax (Tmax)
    Time Frame
    3 days
    Title
    Area under the concentration time-curve
    Time Frame
    3 days
    Title
    Elimination rate konstant (k)
    Time Frame
    3 days
    Title
    Lag time (T-lag)
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Main criteria for inclusion of healthy subjects include: 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. Main criteria for inclusion of patients with mildly active Ulcerative Colitis (UC): 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]). UC patients with occasional streaks of blood in the stool during the past week UC patients with a stool frequency of 1-2/day > normal UC patients whose activity of disease is considered mild by his/her treating gastroenterologist Ability of patient to participate fully in all aspects of this clinical trial Written informed consent must be obtained and documented Exclusion Criteria: Main criteria for exclusion of healthy subjects include: 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. Main criteria for exclusion of UC patients include: The patients will only be included in the study if they do not meet any of the following 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 5mSv in the last twelve months. No patient 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 ALT, AST, total Bilirubin or alkaline phosphatase > 2 times the upper limit of normal Serum Creatinine > 1.5 times the 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, peptic ulceration, gastrointestinal bleedings, Crohn's disease or Irritable Bowel Syndrome (within the previous 12 months) or any other disease which in the opinion of the investigator may interfere with the patient's ability to comply with the study procedures Severe UC defined by the following criteria: ≥ 6 bloody stools daily with one or more of the following oral temperature > 37.8°C pulse > 90/min hemoglobin < 100 g/L History of adverse reaction or allergy to aspirin, mesalazine or other salicylates. Donation of blood within the previous three months. Positive HBV-Antigen, HCV-Antibody or HIV-antibody result. Unwilling to stop oral or rectal mesalazine treatment on the treatment day if on mesalazine treatment before enrolment History of colectomy or partial colectomy History of dysplasia in colonic biopsies Failure to satisfy the Principal Investigator to participate for any other reason

    12. IPD Sharing Statement

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