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Recruiting NCT06379958

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

Phase I Interventional Pharmacokinetics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: leramistat 40mg, Itraconazole 200 mg, Phenytoin 100 Mg Oral Capsule, Simvastatin 40mg.
Who it may be relevant to
Registry conditions: Pharmacokinetics. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug leramistat 40mg
    Oral capsule
  • Drug Itraconazole 200 mg
    Oral capsule
  • Drug Phenytoin 100 Mg Oral Capsule
    Oral capsule
  • Drug Simvastatin 40mg
    Oral capsule
  • Drug Upadacitinib 15 MG
    Oral Capsule

Primary outcome measures

  • leramistat: Area under the curve - AUC0-t [Time frame: 8.5 Weeks]
  • leramistat: Area under the curve - AUC0-24h [Time frame: 8.5 Weeks]
  • leramistat: Area under the curve - AUC0-inf [Time frame: 8.5 weeks]
  • leramistat: Maximum observed concentration - Cmax [Time frame: 8.5 weeks]
  • leramistat: Time of the maximum observed concentration - Tmax [Time frame: 8.5 weeks]
  • leramistat:Elimination rate constant -Kel [Time frame: 8.5 weeks]
  • leramistat: Half life - t½ [Time frame: 8.5 weeks]
  • leramistat: Plasma Clearance -CL/F [Time frame: 8.5 weeks]
  • leramistat: Volume of distribution - Vz/F [Time frame: 8.5 weeks]
Secondary outcome measures (1)
  • Incidence of adverse event. [Time frame: 8.5 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • Celerion — Belfast

Identifiers

NCT: NCT06379958 · IST-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗