RECRUITING

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

Conditions

Healthy Volunteers KarXT Lithium Valproic acid Drug-Drug Interaction study BMS-986510 Pharmacokinetics Lamotrigine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-12-26

Study Completion:2025-10-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06729970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Principal Investigator

Bristol-Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

CenExel Collaborative Neuroscience Research, LLC - Los Alamitos

Los Alamitos, California, 90720-3115

United States

Collaborators and Investigators

Sponsor: Karuna Therapeutics

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-26

Study Completion Date2025-10-17

Study Record Updates

Study Start Date2024-12-26

Study Completion Date2025-10-17

Terms related to this study

Keywords Provided by Researchers

KarXT
Lithium
Valproic acid
Drug-Drug Interaction study
Healthy Volunteers
BMS-986510
Pharmacokinetics
Lamotrigine

Additional Relevant MeSH Terms

Healthy Volunteers