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

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

Study Overview

• Status: Recruiting
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: leramistat 40mg; Drug: Itraconazole 200 mg; Drug: Phenytoin 100 Mg Oral Capsule; Drug: Simvastatin 40mg; Drug: Upadacitinib 15 MG

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Team; Phone Number: +44 (0)207 444 0066; Email: ist05@istesso.co.uk

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • Recruiting
    • Celerion
    • Contact: Phase 1 Unit
    • Principal Investigator: Nadine Abdullah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Part 1: Itraconazole 200mg	Drug: leramistat 40mg; Oral capsule; Drug: Itraconazole 200 mg; Oral capsule
Active Comparator: Part 2: Phenytoin 100mg	Drug: leramistat 40mg; Oral capsule; Drug: Phenytoin 100 Mg Oral Capsule; Oral capsule
Active Comparator: Part 3: Simvastatin 40mg	Drug: leramistat 40mg; Oral capsule; Drug: Simvastatin 40mg; Oral capsule
Active Comparator: Part 4: Upadacitinib 15 mg	Drug: leramistat 40mg; Oral capsule; Drug: Upadacitinib 15 MG; Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse event.	8.5 weeks

Collaborators and Investigators

• Sponsor: Modern Biosciences Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Hormones, Hormone Substitutes, and Hormone Antagonists; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Protein Kinase Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Janus Kinase Inhibitors; Itraconazole; Simvastatin; Phenytoin; Upadacitinib
• Other Study ID Numbers: IST-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No