Madison, Wisconsin
Madison, Wisconsin, 53704, United States
NCT Number: NCT05581823
The primary purpose of this study is to evaluate the effect of carbamazepine, a strong CYP3A4 inducer, on the steady-state pharmacokinetics (PK) of tavapadon in healthy adult participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Madison, Wisconsin, 53704, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Serious risk of suicide in the opinion of the investigator is also exclusionary.
NOTE: Other protocol-defined Exclusion criteria may apply.
Oral tablets
Other names: CVL-751, PF-06649751
Extended-release oral tablets
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 31
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 31
Time frame: Day 1 up to Day 36
Time frame: Up to Day 31
Time frame: Up to Day 31
Time frame: Up to Day 30
Time frame: Up to Day 31
Time frame: Up to Day 31
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for 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, Fixed-sequence, Crossover Trial to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Induction by Carbamazepine on the Steady-state Pharmacokinetics of Tavapadon in Healthy Adult Participants
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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