Drug disposition in the human colon: sampling optimization

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003790-34-BE

Enrollment

Registered

2017-12-04

Start date

2018-01-09

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Trade Name: Pentasa 500 mg tabletten met verlengde afgifte Pharmaceutical Form: Modified-release tablet INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Concentration unit: mg milligram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy volunteers age: 18 - 35 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - allergy for salicylic acid derivatives - acute/chronic GI condition - diabetes, cardiovasular/pulmonary/renal diseases - use of medication (except contraception) - (possible) pregnancy - smoking - HIV / HBV / HCV infection

Design outcomes

Primary

Measure	Time frame
Main Objective: The general aim is to assess the pharmacokinetic disposition of mesalazine in the colon of healthy volunteers. To this end, the present study persues the optimization of the sampling (time and procedure) of colonic fluids and tissue by ileocolonoscopy after intraduodenal delivery of a single dose of Pentasa. Four sampling times will be evaluated using a cross-over design.;Secondary Objective: Not applicable;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Main Objective: The general aim is to assess the pharmacokinetic disposition of mesalazine in the colon of healthy volunteers. To this end, the present study persues the optimization of the sampling (time and procedure) of colonic fluids and tissue by ileocolonoscopy after intraduodenal delivery of a single dose of Pentasa. Four sampling times will be evaluated using a cross-over design.;Secondary Objective: Not applicable;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactDrug Delivery and Disposition

KU Leuven

joachim.brouwers@kuleuven.be+3216330310

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026