NCT05106309 is a Phase 1 clinical trial of 10 mg CVL-231 as IR formulation in Schizophrenia, sponsored by Cerevel Therapeutics, LLC.

Who is sponsoring NCT05106309?

NCT05106309 is sponsored by Cerevel Therapeutics, LLC.

What drugs are being tested in NCT05106309?

Interventions in NCT05106309: 10 mg CVL-231 as IR formulation, 30 mg CVL-231 as slow-release MR formulation, 30 mg CVL-231 as medium release MR formulation, 30 mg CVL-231 as fast release MR formulation, 30 mg CVL-231 Target Release, Fasted, 30 mg CVL-231 Target Release, Fed.

What condition does NCT05106309 study?

NCT05106309 studies Schizophrenia.

Is NCT05106309 still recruiting?

NCT05106309 is currently completed. Last updated 27 April 2022.

Last reviewed 2022-04-27 · How we verify

NCT05106309

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetics of CVL-231 Following Single Oral Administration of Modified- and Immediate-release Formulations in Fasted and Fed Healthy Participants

Completed Phase 1 Last updated 27 April 2022

What this trial tests

Phase 1 trial testing 10 mg CVL-231 as IR formulation in Schizophrenia in 16 participants. Completed in 24 February 2022.

Timeline

29 December 2021

Primary endpoint
24 February 2022

24 February 2022

Quick facts

Lead sponsor	Cerevel Therapeutics, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	29 December 2021
Primary completion	24 February 2022
Estimated completion	24 February 2022
Sites	1 location across United States

Drugs / interventions tested

10 mg CVL-231 as IR formulation
30 mg CVL-231 as slow-release MR formulation — full drug profile →
30 mg CVL-231 as medium release MR formulation — full drug profile →
30 mg CVL-231 as fast release MR formulation — full drug profile →
30 mg CVL-231 Target Release, Fasted — full drug profile →
30 mg CVL-231 Target Release, Fed — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Cerevel Therapeutics, LLC — full company profile →

Who can join

Adults 18 to 55, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A 2-part, crossover design, open-label treatment trial with 4 periods, 4 sequences (Part A) to evaluate MR formulations of CVL-231 and a 2 periods, 2 sequences (Part B) to understand effect of food on CVL-231 exposures from an MR formulation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Progress and Pitfalls in Developing Agents to Treat Neurocognitive Deficits Associated with Schizophrenia.
Veselinović T, Neuner I. · · 2022 · cited 18× · PMID 35831706 · DOI 10.1007/s40263-022-00935-z

Verify or expand the search:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
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NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Cerevel Therapeutics, LLC trials

Trials by the same sponsor.

NCT06435923 — A Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat After a Single Oral Dose in · Phase 1 · completed
NCT06366243 — A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult Participants · Phase 1 · completed
NCT06301971 — A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Partici · Phase 1 · completed
NCT05965219 — A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclid · Phase 1 · completed
NCT05933187 — A Study Evaluating the Pharmacokinetics and Relative Bioavailability of Emraclidine Immediate-Release Tablets in Healthy · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05106309 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cerevel Therapeutics, LLC
Last refreshed: 27 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05106309.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing