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NCT06379958 Clinical Trial

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

Pharmacokinetics Clinical Trial

Official title:
A Phase 1, Open-label, 3-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat and to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06379958
Other study ID # IST-05
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 8, 2024
Est. completion date September 30, 2024

Study information
Verified date May 2024
Source Modern Biosciences Ltd
Contact Study Team
Phone +44 (0)207 444 0066
Email ist05@istesso.co.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A DDI study consisting of 3 parts conducted as an open label, fixed sequence study in healthy adult subjects.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date September 30, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• leramistat 40mg
Oral capsule
• Itraconazole 200 mg
Oral capsule
• Phenytoin 100 Mg Oral Capsule
Oral capsule
• Simvastatin 40mg
Oral capsule

Locations
Country Name City State
United Kingdom Celerion Belfast

Sponsors (1)
Lead Sponsor Collaborator
Modern Biosciences Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary leramistat: Area under the curve - AUC0 t 8.5 Weeks
Primary leramistat: Area under the curve - AUC0 24 8.5 Weeks
Primary leramistat: Area under the curve - AUC0 inf 8.5 weeks
Primary leramistat: Maximum observed concentration - Cmax 8.5 weeks
Primary leramistat: Time of the maximum observed concentration - Tmax 8.5 weeks
Primary leramistat:Elimination rate constant -Kel 8.5 weeks
Primary leramistat: Half life - t½ 8.5 weeks
Primary leramistat: Plasma Clearance -CL/F 8.5 weeks
Primary leramistat: Volume of distribution - Vz/F 8.5 weeks
Secondary Incidence of adverse event. 8.5 weeks
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