Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects
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
1 other identifier
interventional
48
1 country
1
Brief Summary
A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2024
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2024
CompletedStudy Start
First participant enrolled
April 8, 2024
CompletedFirst Posted
Study publicly available on registry
April 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedAugust 9, 2024
August 1, 2024
6 months
April 8, 2024
August 8, 2024
Conditions
Outcome Measures
Primary Outcomes (9)
leramistat: Area under the curve - AUC0-t
8.5 Weeks
leramistat: Area under the curve - AUC0-24h
8.5 Weeks
leramistat: Area under the curve - AUC0-inf
8.5 weeks
leramistat: Maximum observed concentration - Cmax
8.5 weeks
leramistat: Time of the maximum observed concentration - Tmax
8.5 weeks
leramistat:Elimination rate constant -Kel
8.5 weeks
leramistat: Half life - t½
8.5 weeks
leramistat: Plasma Clearance -CL/F
8.5 weeks
leramistat: Volume of distribution - Vz/F
8.5 weeks
Secondary Outcomes (1)
Incidence of adverse event.
8.5 weeks
Study Arms (4)
Part 1: Itraconazole 200mg
ACTIVE COMPARATORPart 2: Phenytoin 100mg
ACTIVE COMPARATORPart 3: Simvastatin 40mg
ACTIVE COMPARATORPart 4: Upadacitinib 15 mg
ACTIVE COMPARATORInterventions
Oral capsule
Eligibility Criteria
You may qualify if:
- Healthy, adult, male or female of non childbearing potential 18 to 55 years of age.
You may not qualify if:
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion
Belfast, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2024
First Posted
April 23, 2024
Study Start
April 8, 2024
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share