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COMPLETED Phase 1

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 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Lamotrigine
  • DRUG Xanomeline/Trospium Chloride
  • DRUG Lithium
  • DRUG Valproic Acid

Study Locations (1)

California

  • Local Institution - 0001 — Los Alamitos

Trial Details

FieldValue
Enrollment Target 133 participants
Start Date 2024-12-26
Est. Completion 2026-01-23
Phase Phase 1

Sponsor

Karuna Therapeutics

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06729970

The ClinicalTrials.gov registry entry for NCT06729970 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karuna Therapeutics, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions — of which Lamotrigine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06729970 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06729970 about?

NCT06729970 is a clinical study titled "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.

What is the current status of trial NCT06729970?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 133 participants. The study started on 2024-12-26. Estimated completion is 2026-01-23.

What conditions does trial NCT06729970 study?

This clinical trial studies the following conditions: Healthy Volunteers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06729970?

The interventions under investigation include: Lamotrigine (DRUG), Xanomeline/Trospium Chloride (DRUG), Lithium (DRUG), Valproic Acid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06729970?

This trial is sponsored by Karuna Therapeutics, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06729970 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial