Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects
Phase 1
Recruiting
- Conditions
- Pharmacokinetics
- Interventions
- Registration Number
- NCT06379958
- Lead Sponsor
- Modern Biosciences Ltd
- Brief Summary
A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Healthy, adult, male or female of non childbearing potential 18 to 55 years of age.
Principal
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 3: Simvastatin 40mg Simvastatin 40mg - Part 1: Itraconazole 200mg Itraconazole 200 mg - Part 2: Phenytoin 100mg Phenytoin 100 Mg Oral Capsule - Part 2: Phenytoin 100mg leramistat 40mg - Part 3: Simvastatin 40mg leramistat 40mg - Part 1: Itraconazole 200mg leramistat 40mg - Part 4: Upadacitinib 15 mg leramistat 40mg - Part 4: Upadacitinib 15 mg Upadacitinib 15 MG -
- Primary Outcome Measures
Name Time Method leramistat: Maximum observed concentration - Cmax 8.5 weeks leramistat:Elimination rate constant -Kel 8.5 weeks leramistat: Area under the curve - AUC0-24h 8.5 Weeks leramistat: Time of the maximum observed concentration - Tmax 8.5 weeks leramistat: Area under the curve - AUC0-t 8.5 Weeks leramistat: Plasma Clearance -CL/F 8.5 weeks leramistat: Area under the curve - AUC0-inf 8.5 weeks leramistat: Volume of distribution - Vz/F 8.5 weeks leramistat: Half life - t½ 8.5 weeks
- Secondary Outcome Measures
Name Time Method Incidence of adverse event. 8.5 weeks
Trial Locations
- Locations (1)
Celerion
🇬🇧Belfast, United Kingdom