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

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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Part AXanomeline/Trospium Chloride-
Part ALithium-
Part BXanomeline/Trospium Chloride-
Part BValproic Acid-
Part CXanomeline/Trospium Chloride-
Part CLithium-
Part DXanomeline/Trospium Chloride-
Part DValproic Acid-
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 abnormalitiesUp to 2 days post discontinuation of dosing
Number of participants with vital sign abnormalitiesUp to 2 days post discontinuation of dosing
Number of participants with 12-lead electrocardiogram (ECG) abnormalitiesUp to 2 days post discontinuation of dosing
Number of participants with clinical laboratory abnormalitiesUp 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

© Copyright 2024. All Rights Reserved by MedPath