Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965219
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-07-20
Brief Title:
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
Sponsor:
Cerevel Therapeutics LLC
Organization:
Cerevel Therapeutics LLC
Study Overview
Official Title:
A Phase 1 Open-label Three-Part Fixed-Sequence Trial in Healthy Adult Participants to Evaluate the Effects of Itraconazole and Carbamazepine on the Single-Dose Pharmacokinetics of Emraclidine and the Effect of Emraclidine on the Single-Dose Pharmacokinetics of Metformin
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None