TP0502-Pharmaco-Scintigraphic-Study and Amendment

NCT02306785 | Completed Phase 1

• 1 other identifier: TP0502 + A
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Tablet release

  3 days

Secondary Outcomes (5)

• 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

Study Arms (3)

Formulation D

EXPERIMENTAL

TP05 Coating D

Drug: TP05 Coating D

Formulation E

EXPERIMENTAL

TP05 Coating E

Drug: TP05 Coating E

Formulation H

EXPERIMENTAL

TP05 Coating H

Drug: TP05 Coating H

Interventions

TP05 Coating D DRUG

One radio-labelled tablet given to subjects

Also known as: Mesalazine

Formulation D

TP05 Coating E DRUG

One radio-labelled tablet given to subjects

Also known as: Mesalazine

Formulation E

TP05 Coating H DRUG

One radio-labelled tablet given to subjects

Also known as: Mesalazine

Formulation H

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tillotts Pharma AG: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: December 3, 2014
• Study Start: October 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2014-11