Evaluating how lithium and valproic acid affect the pharmacokinetics of KarXT in healthy volunteers
A Phase 1, 4-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium and Valproic Acid on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium and Valproic Acid in Healthy Participants
This study tests how the medications lithium and valproic acid affect the way the new drug KarXT works in healthy people.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Karuna Therapeutics Industry-sponsored |
| Locations | 1 site (Los Alamitos, California) |
| Trial ID | NCT06729970 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the interactions between lithium, valproic acid, and KarXT by evaluating how these drugs influence each other's pharmacokinetics in healthy participants. The study will involve administering single doses of KarXT alongside lithium and valproic acid to determine any changes in drug absorption, distribution, metabolism, and excretion. Healthy volunteers will be closely monitored to ensure their safety and the validity of the results. The findings could provide insights into the safe co-administration of these medications.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male and female participants who are not of childbearing potential and meet specific health criteria.
Not a fit: Patients with significant medical conditions or those who have a history of certain diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of drug interactions, leading to safer prescribing practices for patients requiring these medications.
How similar studies have performed: While this study focuses on specific drug interactions, similar studies have shown success in understanding pharmacokinetics and drug-drug interactions.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Los Alamitos, California
- CenExel Collaborative Neuroscience Research, LLC - Los Alamitos — Los Alamitos, California, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.