FindTrial
Sign In

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06379958
Enrollment
48
Registered
2024-04-23
Start date
2024-04-08
Completion date
2024-09-30
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Brief summary

A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.

Interventions

DRUGleramistat 40mg

Oral capsule

DRUGItraconazole 200 mg

Oral capsule

DRUGPhenytoin 100 Mg Oral Capsule

Oral capsule

DRUGSimvastatin 40mg

Oral capsule

DRUGUpadacitinib 15 MG

Oral Capsule

Sponsors

Modern Biosciences Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

Principal Inclusion Criteria: Healthy, adult, male or female of non childbearing potential 18 to 55 years of age. Principal

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
leramistat: Volume of distribution - Vz/F8.5 weeks
leramistat: Area under the curve - AUC0-t8.5 Weeks
leramistat: Area under the curve - AUC0-24h8.5 Weeks
leramistat: Area under the curve - AUC0-inf8.5 weeks
leramistat: Maximum observed concentration - Cmax8.5 weeks
leramistat: Time of the maximum observed concentration - Tmax8.5 weeks
leramistat:Elimination rate constant -Kel8.5 weeks
leramistat: Half life - t½8.5 weeks
leramistat: Plasma Clearance -CL/F8.5 weeks

Secondary

MeasureTime frame
Incidence of adverse event.8.5 weeks

Countries

United Kingdom

Contacts

Primary ContactStudy Team
ist05@istesso.co.uk+44 (0)207 444 0066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026