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
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05965219
- Lead Sponsor
- Cerevel Therapeutics, LLC
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part C: Metformin Followed by Emraclidine + Metformin Emraclidine Participants will receive a single oral dose of metformin 850 mg on Day 1 in TP 1 followed by emraclidine 30 mg, orally, QD for Days 1 to 10, with a single oral dose of metformin 850 mg co-administered on Day 8 in TP 2. Part A: Emraclidine Followed by Itraconazole + Emraclidine Emraclidine Participants will receive a single oral dose of emraclidine 10 milligrams (mg) on Day 1 in Treatment Period (TP) 1 followed by itraconazole 200 mg, orally, twice daily (BID) on Day 1 and once daily (QD) from Days 2 to 14, with a single oral dose of emraclidine 10 mg co-administered on Day 5 in TP 2. Part A: Emraclidine Followed by Itraconazole + Emraclidine Itraconazole Participants will receive a single oral dose of emraclidine 10 milligrams (mg) on Day 1 in Treatment Period (TP) 1 followed by itraconazole 200 mg, orally, twice daily (BID) on Day 1 and once daily (QD) from Days 2 to 14, with a single oral dose of emraclidine 10 mg co-administered on Day 5 in TP 2. Part B: Emraclidine Followed by Carbamazepine + Emraclidine Emraclidine Participants will receive a single oral dose of emraclidine 30 mg on Day 1 in TP 1 followed by carbamazepine 100 mg BID from Days 1 to 3, 200 mg BID from Days 4 to 6, and 300 mg BID from Days 7 to 19, orally, with a single oral dose of emraclidine 30 mg on Day 16 in TP 2. Part B: Emraclidine Followed by Carbamazepine + Emraclidine Carbamazepine Participants will receive a single oral dose of emraclidine 30 mg on Day 1 in TP 1 followed by carbamazepine 100 mg BID from Days 1 to 3, 200 mg BID from Days 4 to 6, and 300 mg BID from Days 7 to 19, orally, with a single oral dose of emraclidine 30 mg on Day 16 in TP 2. Part C: Metformin Followed by Emraclidine + Metformin Metformin Participants will receive a single oral dose of metformin 850 mg on Day 1 in TP 1 followed by emraclidine 30 mg, orally, QD for Days 1 to 10, with a single oral dose of metformin 850 mg co-administered on Day 8 in TP 2.
- Primary Outcome Measures
Name Time Method Part C: AUC0-t of Metformin Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364 Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A Part B: Cmax of Emraclidine and its Metabolite CV-0000364 Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B Part C: Cmax of Metformin Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364 Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364 Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A Part B: AUCinf of Emraclidine and its Metabolite CV-0000364 Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B Part C: AUCinf of Metformin Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C Part B: AUC0-t of Emraclidine and its Metabolite CV-0000364 Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values Up to end of treatment in each part of the study (up to an average of 15 days) Number of Participants With Clinically Significant Changes in Vital Sign Measurements Up to end of treatment in each part of the study (up to an average of 15 days) Number of Participants With Clinically Significant Changes in Laboratory Assessments Up to end of treatment in each part of the study (up to an average of 15 days) Number of Participants With Treatment-emergent Adverse Events (TEAEs) Based on Severity From the first dose up to 1 month following last dose with investigational medicinal product (IMP) in each part of the study Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results Up to end of treatment in each part of the study (up to an average of 15 days) Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score Up to end of treatment in each part of the study (up to an average of 15 days) The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Trial Locations
- Locations (1)
Overland Park, Kansas
🇺🇸Overland Park, Kansas, United States