Overland Park, Kansas
Overland Park, Kansas, 66212, United States
NCT Number: NCT05965219
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Overland Park, Kansas, 66212, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for All Participants:
Inclusion criteria
for Part A:
Inclusion criteria
for Part B:
Inclusion criteria
for Part C:
Exclusion criteria
for All Participants:
Exclusion criteria
for Part A:
Exclusion criteria
for Part B:
Exclusion criteria
for Part C:
[Note: Other inclusion and exclusion criteria as per protocol may apply.]
Emraclidine tablets.
Itraconazole oral solution.
Other names: Sporanox
Carbamazepine tablets.
Other names: Tegretol-XR
Metformin tablets.
Other names: Glucophage
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the first dose up to 1 month following last dose with investigational medicinal product (IMP) in each part of the study
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Time frame: 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.
Cerevel Therapeutics, LLC
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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