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A Phase 1, Open-label, 4-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat, to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin, and to Evaluate the Pharmacokinetic Interaction Between Leramistat and Upadacitinib (RINVOQ®) in Healthy Adult Subjects
A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Celerion
Belfast, United Kingdom
Start Date
April 8, 2024
Primary Completion Date
September 30, 2024
Completion Date
September 30, 2024
Last Updated
August 9, 2024
48
ESTIMATED participants
leramistat 40mg
DRUG
Itraconazole 200 mg
DRUG
Phenytoin 100 Mg Oral Capsule
DRUG
Simvastatin 40mg
DRUG
Upadacitinib 15 MG
DRUG
Lead Sponsor
Modern Biosciences Ltd
NCT07052162
NCT04961593
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06426836