A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
Phase 1
Recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT06729970
- Lead Sponsor
- Karuna Therapeutics
- Brief Summary
The purpose of this study is to evaluate the effects of lithium, valproic acid, and lamotrigine on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium, valproic acid, and lamotrigine in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- Healthy male and female [individual not of childbearing potential (INOCBP)] participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory determinations.
- BMI of 18.0 to 32.0 kg/m2, inclusive.
Exclusion Criteria
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. Note: Any grade of hepatic impairment (Child-Pugh Grade A or higher) is excluded.
- Parts B and D only: History of pancreatitis.
- Any significant acute or chronic medical illness, in the opinion of the investigator.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
- Parts E & F only: history of skin rash and mucus ulcerations of no obvious cause and Gilbert's syndrome
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A Xanomeline/Trospium Chloride - Part A Lithium - Part B Xanomeline/Trospium Chloride - Part B Valproic Acid - Part C Xanomeline/Trospium Chloride - Part C Lithium - Part D Xanomeline/Trospium Chloride - Part D Valproic Acid - Part E Xanomeline/Trospium Chloride - Part E Lamotrigine - Part F Xanomeline/Trospium Chloride - Part F Lamotrigine - Part A Xanomeline/Trospium Chloride - Part A Lithium - Part B Xanomeline/Trospium Chloride - Part B Valproic Acid - Part C Xanomeline/Trospium Chloride - Part C Lithium - Part D Xanomeline/Trospium Chloride - Part D Valproic Acid -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to day 54 Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Up to day 54 Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Up to day 54
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 28 days post discontinuation of dosing Number of participants with serious adverse events (SAEs) Up to 28 days post discontinuation of dosing Number of participants with physical examination abnormalities Up to 2 days post discontinuation of dosing Number of participants with vital sign abnormalities Up to 2 days post discontinuation of dosing Number of participants with 12-lead electrocardiogram (ECG) abnormalities Up to 2 days post discontinuation of dosing Number of participants with clinical laboratory abnormalities Up to 2 days post discontinuation of dosing Columbia-Suicide Severity Rating Scale (C-SSRS) Up to 2 days post discontinuation of dosing Number of participants with AEs of Special Interest (AESIs) Up to 28 days post discontinuation of dosing
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms mediate KarXT-lithium/valproic acid PK interactions in Karuna Therapeutics' NCT06729970 trial?
How do KarXT-lithium/valproic acid pharmacokinetic interactions compare to standard-of-care mood stabilizer combinations?
Which CYP enzymes or transporters predict adverse events in KarXT-lithium/valproic acid drug interactions?
What are the safety profiles of KarXT combined with lithium or valproic acid in healthy volunteers?
How do KarXT's pharmacokinetic interactions compare to other muscarinic agonist-mood stabilizer combinations in bipolar disorder?
Trial Locations
- Locations (1)
CenExel Collaborative Neuroscience Research, LLC - Los Alamitos
🇺🇸Los Alamitos, California, United States
CenExel Collaborative Neuroscience Research, LLC - Los Alamitos🇺🇸Los Alamitos, California, United StatesSteven Reynolds, Site 0001Contact