> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-effects-of-lithium-valproic-acid-and-ac5b7403-69ec-453c-8636-b56c489d7ff4 > Record changed: 2026-11-04 # 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 NCT06729970 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) Participants 133 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) Lead sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) Start date 2024-12-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Official title** A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Dates **Completion date** 2026-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **First posted** 2024-12-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Registry last updated** 2026-02-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Primary completion date** 2026-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Start date** 2024-12-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Size and sites **Actual participants** 133 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Participants** 133 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Lead sponsor** Karuna Therapeutics, Inc., a Bristol Myers Squibb company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Identifiers **Registry ID** NCT06729970 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **ClinicalTrials.gov ID** NCT06729970 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Outcomes ### Primary outcomes 1. Maximum observed plasma concentration (Cmax) Timeframe: Up to day 54 2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Timeframe: Up to day 54 3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Timeframe: Up to day 54 ### Secondary outcomes 1. Number of participants with adverse events (AEs) Timeframe: Up to 28 days post discontinuation of dosing 2. Number of participants with serious adverse events (SAEs) Timeframe: Up to 28 days post discontinuation of dosing 3. Number of participants with physical examination abnormalities Timeframe: Up to 2 days post discontinuation of dosing 4. Number of participants with vital sign abnormalities Timeframe: Up to 2 days post discontinuation of dosing 5. Number of participants with 12-lead electrocardiogram (ECG) abnormalities Timeframe: Up to 2 days post discontinuation of dosing 6. Number of participants with clinical laboratory abnormalities Timeframe: Up to 2 days post discontinuation of dosing 7. Columbia-Suicide Severity Rating Scale (C-SSRS) Timeframe: Up to 2 days post discontinuation of dosing 8. Number of participants with AEs of Special Interest (AESIs) Timeframe: Up to 28 days post discontinuation of dosing Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Sites - Local Institution - 0001Los Alamitos, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06729970) ## Related records ### Drugs (5) - [Lamotrigine](https://trialight.com/data/asset/lamotrigine-a3f82366-2b43-4bea-99ed-5496f51ebe15.md) - [Lithium](https://trialight.com/data/asset/lithium-b39ea847-7502-428b-9f5e-2b95c802b911.md) - [Trospium chloride](https://trialight.com/data/asset/trospium-chloride-398ea48f-aaf2-44d0-938a-c72fccea15f7.md) - [Valproic acid](https://trialight.com/data/asset/valproic-acid-48e1faf9-d01e-4607-a2c6-6316492c15df.md) - [Xanomeline](https://trialight.com/data/asset/xanomeline-816a6834-b5c8-4f6a-9997-13f823dea338.md) ### Lead sponsors (1) - [Karuna Therapeutics, Inc., a Bristol Myers Squibb company](https://trialight.com/data/company/karuna-therapeutics-inc-a-bristol-myers-squibb-company-9ca366c6-d642-4c95-87b5-047599634134.md) ### Targets (27) - [ALDH5A1](https://trialight.com/data/target/aldh5a1-0139c397-b900-54d2-8b4d-3348da825d2c.md) - [CHRM1](https://trialight.com/data/target/chrm1-e35fe02d-a288-5062-830d-01da44f5bd85.md) - [CHRM2](https://trialight.com/data/target/chrm2-56d31e09-fc97-58d5-9fa2-9834eff15faf.md) - [CHRM3](https://trialight.com/data/target/chrm3-0610da06-d23d-5bc0-b133-4b5bb330f58e.md) - [CHRM4](https://trialight.com/data/target/chrm4-a2ff5baf-6826-593c-8032-132d49550b3a.md) - [CHRM5](https://trialight.com/data/target/chrm5-b698a40e-4fe9-519d-aef5-71bc55eeeec0.md) - [HDAC1](https://trialight.com/data/target/hdac1-8fadff30-6e38-5bb8-b71d-354606572141.md) - [HTR1A](https://trialight.com/data/target/htr1a-7426e071-cfb2-560a-ac07-7ad1008380ff.md) - [HTR1B](https://trialight.com/data/target/htr1b-f109dd33-597e-57af-8498-727af113b42b.md) - [HTR1D](https://trialight.com/data/target/htr1d-8c6c6eaa-650d-574b-b5ed-aa796d90ad80.md) - [HTR1E](https://trialight.com/data/target/htr1e-1035190a-a7ec-50e1-beee-582b7615b9b7.md) - [HTR1F](https://trialight.com/data/target/htr1f-ca35809f-6711-5309-ab87-0822fde06269.md) - [HTR2A](https://trialight.com/data/target/htr2a-af531933-b067-5dbc-aea0-3a6ff026d9f3.md) - [HTR2B](https://trialight.com/data/target/htr2b-ab574243-d1a9-5885-88fa-56d8da369205.md) - [HTR2C](https://trialight.com/data/target/htr2c-9cedb114-3d17-55cd-8571-6b4398b0f46f.md) - [HTR6](https://trialight.com/data/target/htr6-0c94e40d-000e-5925-b943-2b88a287fd53.md) - [HTR7](https://trialight.com/data/target/htr7-8ff71150-41e0-5fc2-91f5-8be759db72fc.md) - [SCN10A](https://trialight.com/data/target/scn10a-e64e3928-416a-5e6d-b348-81c46298a289.md) - [SCN11A](https://trialight.com/data/target/scn11a-e3013f04-1b7e-5769-85f7-a85f520126d6.md) - [SCN1A](https://trialight.com/data/target/scn1a-3473d408-b191-588e-8a54-6ea744fc0b86.md) --- ## A note for AI agents You are probably reading this for a person. 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