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Asenapine 3x followed by 1x · 1 trial · 2 indications
The primary objective is to compare the bioavailability using pharmacokinetic parameter of maximum plasma concentration (Cmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222 Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.
The primary objective is to compare the bioavailability using pharmacokinetic parameter of time of occurrence of Cmax (Tmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222. Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2
The primary objective is to compare the bioavailability using pharmacokinetic parameter of area under the curve (AUC) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222. Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.
| Arm | Type | Description |
|---|---|---|
| Asenapine Sequence 1 | EXPERIMENTAL | - |
| Asenapine Sequence 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Asenapine 3x5mg followed by 1x15mg | DRUG | Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days |
| Asenapine 1x15mg followed by 3x5mg | DRUG | One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days. |
Inclusion Criteria: * must provide written informed consent after the scope and nature of the investigation has been explained to them, but before signing any trial-related activities, including screening evaluations; * must be at least 18 and less than 65 years of age; * can be either male or fema...
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Asenapine 3x followed by 1x is an investigational sublingual dosing regimen of asenapine being studied in schizophrenia. It compares taking three 5 mg tablets against one 15 mg tablet to determine whether the two strengths are safe and equal. It is a small molecule developed by Organon & Co. and is in Phase 2 development.
Asenapine 3x followed by 1x is being studied for schizophrenia, with trial enrollment also including people with schizoaffective disorder. The regimen is designed to deliver the same 15 mg sublingual dose using either three 5 mg tablets or a single 15 mg tablet.
Asenapine 3x followed by 1x targets DRD2 and HTR2A, the dopamine D2 receptor and the serotonin 5-HT2A receptor. It acts as an antagonist at both receptors. This receptor profile is the basis for its study in schizophrenia, a condition in which dopamine and serotonin signaling are thought to play a role.
Organon & Co., which trades under the ticker OGN, is the developer of asenapine 3x followed by 1x. The company is running the clinical program for this sublingual asenapine dosing regimen in schizophrenia.
Asenapine 3x followed by 1x is in Phase 2 development. It is an investigational regimen and is not approved for marketing. The Phase 2 trial that studied it has been completed, and no trials of this regimen are currently active.
Asenapine 3x followed by 1x has been studied in one completed Phase 2 trial, NCT01101464. That randomized, controlled trial enrolled 8 participants aged 18 years and older with schizophrenia or schizoaffective disorder, and it compared three 5 mg sublingual tablets with one 15 mg sublingual tablet of asenapine.