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OpenTrials
Completed

NCT Number: NCT06729970

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Los Alamitos, California, 90720-3115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xanomeline/Trospium Chloride

Drug

Specified dose on specified days

Other names: BMS-986510, KarXT

Lithium

Drug

Specified dose on specified days

Valproic acid

Drug

Specified dose on specified days

Lamotrigine

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to day 54

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to day 54

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to day 54

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 28 days post discontinuation of dosing

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 28 days post discontinuation of dosing

  3. Number of participants with physical examination abnormalities

    Time frame: Up to 2 days post discontinuation of dosing

  4. Number of participants with vital sign abnormalities

    Time frame: Up to 2 days post discontinuation of dosing

  5. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Time frame: Up to 2 days post discontinuation of dosing

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 2 days post discontinuation of dosing

  7. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to 2 days post discontinuation of dosing

  8. Number of participants with AEs of Special Interest (AESIs)

    Time frame: Up to 28 days post discontinuation of dosing

Sponsors and collaborators

Lead sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2024
Registry last updated
Feb 24, 2026

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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