(IPCOM) Influence of Proton pump inhibitor CO-medication on the absorption of innovator and generic formulations of Mycophenolate mofetil

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Digestive System Diseases [C06]

Trial duration

8 Jul 2025 → 18 Nov 2025

Decision date (initial)

2025-02-28

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

Primary Objectives are 1) To determine the influence of PPI co-treatment on the pharmacokinetics of different formulations of MMF (generic and innovator); 2) To compare the bio-equivalence between innovator MMF and generic formulations of MMF, in subjects co-treated with PPI.

Conditions and MedDRA coding

Post Transplantation Patients

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Healthy volunteers (male) as determined by medical history, clinical laboratory tests and physical examination. • ≥ 18 and ≤ 55 years of age • Body weight > 50 kg and Body Mass Index (BMI) between 18.5 and 30 kg/m2 • Vital signs (systolic blood pressure 90–149 mmHg, diastolic blood pressure 50–89 mmHg, heart rate 50–90 bpm, measured after 5 min at rest in the sitting position) • Clinical laboratory test (biochemistry and haematology blood tests and urinalysis) results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. • The ability to fully comprehend the nature and aims of the study, including possible risks and side effects. • Written informed consent

Exclusion criteria 1

1. A potential subject who meets any of the following criteria will be excluded from participation in this study: • Hypersensitivity to the active substance and/or any of the excipients of the formulations or a history of anaphylaxis to drugs or allergic reactions in general. • Moderate or severe hepatic impairment (Child-Pugh A, B or C) • Moderate or severe renal impairment (eGFR below 60 mL/min) • History or presence of clinically significant disease • Clinically significant abnormal physical findings • Clinically significant abnormal laboratory values indicative of physical illness (including hepatic and renal panels, complete blood count). • Participation in the evaluation of any investigational product or donation of blood for 3 months before this study • History of alcohol or drug abuse within the last year • Use of prescription medications within 14 days of study drug administration or over-the-counter (OTC) medications, herbal supplements, or multivitamins within 7 days, with the exception of paracetamol (up to 4 gram/day).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. As primary endpoint the C-max and the area under the concentration-time curve (AUC)(0-12) of MPA will be calculated. Comparisons will be made between the three formulations in AUC according to the criteria for demonstrating bio-equivalence.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leids Universitair Medisch Centrum (LUMC)

Sponsor organisation

Leids Universitair Medisch Centrum (LUMC)

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Kim Gombert-Handoko

Public contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Kim Gombert-Handoko

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications