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CVL-231 as IR formulation

Phase 1

Schizophrenia | Small molecule | Psychiatry |AbbVie Inc.|Trials Updated: Apr 26, 2022

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

CVL-231 as IR formulation clinical trials

CVL-231 as IR formulation · 1 trial · 1 indication

Phase 1 1
NCT05106309Pharmacokinetics of CVL-231 Following Single Oral Administration of Modified- and Immediate-release Formulations in Fasted and Fed Healthy ParticipantsSchizophrenia
COMPLETED16 Analytics
PHASE1COMPLETED
Pharmacokinetics of CVL-231 Following Single Oral Administration of Modified- and Immediate-release Formulations in Fasted and Fed Healthy Participants
SchizophreniaUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
10 mg CVL-231 as IR formulationDRUGTablets
30 mg CVL-231 as slow-release MR formulationDRUGCapsules
30 mg CVL-231 as medium release MR formulationDRUGCapsules
30 mg CVL-231 as fast release MR formulationDRUGCapsules
30 mg CVL-231 Target Release, FastedDRUGCapsules
30 mg CVL-231 Target Release, FedDRUGCapsules
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Frequently asked questions about CVL-231 as IR formulation

What is CVL-231 as IR formulation?

CVL-231 as IR formulation is an immediate-release oral small molecule that AbbVie Inc. is developing for schizophrenia. It is an investigational Phase 1 asset and has not been approved for any use. The immediate-release version is distinct from other formulations of CVL-231 studied in clinical development.

What is CVL-231 as IR formulation used for?

CVL-231 as IR formulation is being studied for schizophrenia, a psychiatric disorder. The clinical work to date has focused on how the drug behaves in the body rather than on treating patients, since the program remains in Phase 1 development. No approved indication exists for this formulation.

Who makes CVL-231 as IR formulation?

AbbVie Inc. (ticker ABBV) is the developer of CVL-231 as IR formulation. The company holds the program for this immediate-release oral small molecule, which is being evaluated in schizophrenia. AbbVie is the sponsor of the registered clinical trial for this formulation.

What phase is CVL-231 as IR formulation in?

CVL-231 as IR formulation is in Phase 1 development. It is an investigational drug and is not FDA approved. The single registered trial for this formulation has been completed, and no active trials for it are currently listed.

What clinical trials is CVL-231 as IR formulation in?

CVL-231 as IR formulation has been studied in one completed Phase 1 trial, NCT05106309. That trial examined the pharmacokinetics of CVL-231 after single oral doses of modified-release and immediate-release formulations in fasted and fed healthy participants, and it enrolled 16 participants. The study was uncontrolled and is now complete.