A Study to Evaluate the Effects of Lithium and Valproic Acid on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium and Valproic Acid in Healthy Participants
Phase 1
Not yet recruiting
- Conditions
- Interventions
- Registration Number
- NCT06729970
- Lead Sponsor
- Karuna Therapeutics
- Brief Summary
The purpose of this study is to evaluate the effects of lithium and valproic acid on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium and valproic acid in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 88
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.
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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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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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 -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Day 1 and Day 14-16 Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Day 1-3 and Day 14-16 Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Day 1-3 and Day 14-16
- 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 Severe AEs (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
Trial Locations
- Locations (1)
Site 0001
🇺🇸Princeton, New Jersey, United States