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TP0502-Pharmaco-Scintigraphic-Study and Amendment

NCT02306785 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-12-03

No results posted yet for this study

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

Interventions

DRUG

TP05 Coating D

One radio-labelled tablet given to subjects

DRUG

TP05 Coating E

One radio-labelled tablet given to subjects

DRUG

TP05 Coating H

One radio-labelled tablet given to subjects

Sponsors & Collaborators

  • Tillotts Pharma AG

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-02-28
Completion
2013-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02306785 on ClinicalTrials.gov