NCT02306785

TP0502-Pharmaco-Scintigraphic-Study and Amendment

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Tillotts Pharma AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-02-01
• Completion: 2013-06-01
• First posted: 2014-12-03
• Last updated: 2014-12-03