Assessment of the influence of the gut microbiome on tacrolimus pharmacokinetics in healthy volunteers - TacroBiom

niversitätsklinikum Heidelberg, Im Wege der Auftragsverwaltung für die Universität Heidelberg, Medizinische Fakultät Heidelberg0 sites20 target enrollmentAugust 2, 2023

ConditionsPharmacokinetic trial in healthy volunteers

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pharmacokinetic trial in healthy volunteers
Sponsor: niversitätsklinikum Heidelberg, Im Wege der Auftragsverwaltung für die Universität Heidelberg, Medizinische Fakultät Heidelberg
Enrollment: 20
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 2, 2023

End Date

March 28, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversitätsklinikum Heidelberg, Im Wege der Auftragsverwaltung für die Universität Heidelberg, Medizinische Fakultät Heidelberg

Eligibility Criteria

Inclusion Criteria

•Written, personally signed and dated informed consent to participate in the trial prior to any trial\-related interventions.
•Understanding, ability, and willingness to fully comply with trial interventions and restrictions.
•Body weight \= 45 kg.
•Willingness to use a highly effective method of contraception.
•CYP3A5\*3/\*3 genotype.
•Agreement to follow specified dietary requirements.
•Willingness to adhere to rules and restrictions necessary to ensure adequate bowel cleansing.
•Willingness to adhere to pandemic regulations if any may occur during the trial.

Exclusion Criteria

•Clinically significant or relevant abnormalities as assessed by the investigator in the medical history, or findings from physical examination, or laboratory evaluation.
•Any acute or chronic illness expected to influence the volunteer´s gut microbiome composition.
•Intake of antibiotics (p.o. or i.v.) in the six weeks prior to expected first IMP administration.
•Any acute or chronic illness or clinically relevant finding known or expected to modify absorption, distribution, metabolism, or excretion of tacrolimus or midazolam.
•Any known history of severe anaphylactic reactions to drugs or vaccinations, or any other significant allergies.
•Any known allergies to the trial drugs, to other macrolides, or further ingredients of the administered IMPs.
•Glucose\-6\-phosphate dehydrogenase deficiency.
•QTcF \> 440 ms (males) or \> 460 ms (females).
•Use of an IMP within 30 d prior to the expected date of receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial.
•Regular use of any medication (prescription medication, non\-prescription medication including herbal preparations) with active ingredients (except hormonal contraception, iodine, and thyroid hormones).