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drugset / Trial / NCT05965219

A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclidine on the Pharmacokinetics of Metformin in Healthy Adult Participants

NCT05965219 ↗

Phase 1 Completed 60 enrolled Cerevel Therapeutics, LLC
RandomizedCrossoverOpen-labelTreatment

Summary

The primary purpose of the study is to evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the PK of emraclidine and metabolite CV-0000364 in Part B, and to evaluate the effect of emraclidine on the PK of metformin in Part C in healthy adult participants.

Timeline

Start
2023-08-15
Primary completion
2023-11-10
Completion
2023-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbamazepine Small molecule 300 mg Oral
Subject Emraclidine Small molecule 10 mg Oral
Subject Emraclidine Small molecule 30 mg Oral
Subject Itraconazole Small molecule 200 mg Oral
Subject Metformin Small molecule 850 mg Oral

Indications

No indication recorded.