NCT06379958

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Modern Biosciences Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2024-04-23
• Last updated: 2024-08-09

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study