Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Participants

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Renodapt; Drug: Mycept; Drug: Cellmune; Drug: CellCept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02981290

WP21980

Details and patient eligibility

About

This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites from 4 tablet formulations in healthy participants.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

A body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m^2)

Exclusion criteria

• Any evidence of clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastro-intestinal, neurological, metabolic or immunodeficiency disorders, cancer, hepatitis or cirrhosis
• Any evidence of gall bladder surgery, surgery of the gastro-intestinal tract or any other medical condition considered likely to affect drug absorption
• Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
• Any known history of clinically significant allergic reactions or drug hypersensitivity, especially hypersensitivity to MMF or mycophenolic acid (MPA)
• Any other ongoing concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participants
• Any prescribed or over-the-counter (OTC) medication, herbal medicine or dietary aid taken within 2 weeks before the first study drug dosing or within six times the elimination half-life of the medication before the first study drug dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Renodapt Then Mycept Then Cellmune Then CellCept

Experimental group

Description:

Participants will receive Renodapt in first treatment period (each treatment period= 3 days) followed by Mycept in second treatment period then Cellmune in third treatment period and CellCept in fourth treatment period. A washout period of 7 days will be separating each treatment period.

Treatment:

Drug: Cellmune

Drug: Renodapt

Drug: CellCept

Drug: Mycept

Mycept Then CellCept Then Renodapt Then Cellmune

Experimental group

Description:

Participants will receive Mycept in first treatment period (each treatment period= 3 days) followed by CellCept in second treatment period then Renodapt in third treatment period and Cellmune in fourth treatment period. A washout period of 7 days will be separating each treatment period.

Treatment:

Drug: Cellmune

Drug: Renodapt

Drug: CellCept

Drug: Mycept

Cellmune Then Renodapt Then CellCept Then Mycept

Experimental group

Description:

Participants will receive Cellmune in first treatment period (each treatment period= 3 days) followed by Renodapt in second treatment period then CellCept in third treatment period and Mycept in fourth treatment period. A washout period of 7 days will be separating each treatment period.

Treatment:

Drug: Cellmune

Drug: Renodapt

Drug: CellCept

Drug: Mycept

CellCept Then Cellmune Then Mycept Then Renodapt

Experimental group

Description:

Participants will receive CellCept in first treatment period (each treatment period= 3 days) followed by Cellmune in second treatment period then Mycept in third treatment period and Renodapt in fourth treatment period. A washout period of 7 days will be separating each treatment period.

Treatment:

Drug: Cellmune

Drug: Renodapt

Drug: CellCept

Drug: Mycept