TP0501 - Pharmaco-Scintigraphic-Study

NCT02306772 | Completed Phase 1

• 1 other identifier: TP0501
• Study Type: interventional
• Target: 18
• 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. Overall, nine \[9\] subjects per prototype coating (a total of 18) will be evaluated. Eligible subjects will be assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive formulation B and the second 9 subjects will receive formulation A. The subjects will be treated once with the radio-labelled study medication.

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 constant (k)

  3 days

• Lag time (t-lag)

  3 days

Study Arms (2)

Formulation A

EXPERIMENTAL

TP05 Coating A

Drug: TP05 Coating A

Formulation B

EXPERIMENTAL

TP05 Coating B

Drug: TP05 Coating B

Interventions

TP05 Coating A DRUG

One radio-labelled tablet given to subjects

Also known as: Mesalazine

Formulation A

TP05 Coating B DRUG

One radio-labelled tablet given to subjects

Also known as: Mesalazine

Formulation B

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.
• Voluntarily signed 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 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.

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: December 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 3, 2014

Record last verified: 2014-11