Clinical Trials Logo
  1. Home
  2. Pharmacokinetics
  3. NCT06379958
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04092725 - Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects Phase 1
Completed NCT04181008 - Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers Early Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT04406415 - Oral Nafamostat in Healthy Volunteers Phase 1
Not yet recruiting NCT05421312 - Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip Phase 4
Completed NCT02534753 - A Pharmacokinetics Study of Intravenous Ascorbic Acid Phase 1
Completed NCT01636024 - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594 Phase 1
Completed NCT01682408 - Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability Phase 1
Completed NCT01976078 - Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents N/A
Completed NCT01415102 - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372. Phase 1
Completed NCT01214941 - Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol Phase 4
Completed NCT01208155 - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets Phase 1
Completed NCT01260025 - Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor Phase 1
Completed NCT01276119 - The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males Phase 1
Completed NCT00746499 - Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women. Phase 1
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT00983242 - Drug-Drug Interaction Between Colchicine and Verapamil ER Phase 1
Completed NCT00856570 - A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects Phase 1
Completed NCT00984009 - A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice Phase 1
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1