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NCT06729970 · ClinicalTrials.gov registry record · 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
A Phase 1 study of Healthy Volunteers, sponsored by Karuna Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 133
- Enrollment target
- 1
- Study location
NCT06729970: Completed Phase 1 study of Healthy Volunteers, sponsored by Karuna Therapeutics.
NCT06729970 is a Phase 1 study of Healthy Volunteers that has completed, run by Karuna Therapeutics. The registered enrollment target is 133 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06729970, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Karuna Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 133 participants
- Enrollment target
- 1
- Study location
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
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2024-12-26 |
| Est. Completion | 2026-01-23 |
| Phase | Phase 1 |
What the finished NCT06729970 record still lists
NCT06729970 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (72% lower).
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.
NCT06729970 reports a single indexed study location in California.
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.
What interventions are being tested in trial NCT06729970?
The interventions under investigation include: Lamotrigine (DRUG), Xanomeline/Trospium Chloride (DRUG), Lithium (DRUG), Valproic Acid (DRUG).
Who is sponsoring clinical trial NCT06729970?
This trial is sponsored by Karuna Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06729970's enrollment target sits among peer trials
133 64th of 283 higher than 220 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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