P-glypoprotein Inhibition Effect on the Pharmacokinetics of Two Tacrolimus Formulations: Prolonged and Extended-release

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

February 15, 2022

Primary Completion Date

May 16, 2023

Study Completion Date

May 16, 2023

Conditions
Pharmacokinetics
Interventions
DRUG

Treatment A

Administration of a 3 mg dose of prolonged-release tacrolimus (Advagraf®)

DRUG

Treatment B

Administration of a 2 mg dose of LCP-tacro (Envarsus®)

DRUG

Treament C

Administration of a single 120 mg dose of immediate-release verapamil (Isoptine®) and a 3 mg dose of prolonged-release tacrolimus (Advagraf®)

DRUG

Treatment D

Administration of a single 120 mg dose of immediate release verapamil (Isoptine®) and a 2 mg dose of LCP-tacro (Envarsus®)

BIOLOGICAL

Pharmacocinetik

Nine sampling points of 7 ml each will be taken on the first day at the CIC UIC and the last sampling point will be carried out at 24 hours from the administration the following morning.

GENETIC

Genetic

A genetic analysis to determine your characteristics for enzymes in your metabolism as well as transport proteins will be carried out. An additional 7 ml blood tube will be drawn for this purpose during the first period.

OTHER

Selection visit:

"During this visit, it will be asked to sign the following consent and it will be carried out:~* a clinical examination (questioning and physical examination with measurement of height and weight);~* a blood test (18 mL);~* a blood pregnancy test if you are a woman;~* a cardiac assessment (electrocardiogram).~These results should be normal."

Trial Locations (1)

35055

CHU de Rennes, Rennes

All Listed Sponsors
lead

Rennes University Hospital

OTHER