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This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the safety, tolerability, and pharmacokinetic profile.
This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-911 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions.
The primary objectives are to evaluate the safety and tolerability of SUVN-911 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-911, if possible.
The secondary objectives are to evaluate the single and repeat dose plasma and urine pharmacokinetics of SUVN-911 following oral administration of single and multiple ascending doses in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose | Active Comparator | Single dose of SUVN-911 or placebo in healthy male subjects |
|
| Multiple ascending dose | Active Comparator | Multiple doses of SUVN-911 or placebo in healthy male subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUVN-911 | Drug | Oral Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ECG (Electrocardiogram) | electrocardiogram outcomes | Range of Day 1-17 |
| Vital signs | blood pressure determination | Range of Day 1-17 |
| C-SSRS (Columbia Suicidal Severity Rating Scale) | Columbia Suicidal Severity Rating in multiple doses | Range of Day 1-17 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | Plasma concentration | Day 1 and Day 14 |
| Maximum observed concentration (Cmax) | Maximum concentration observed |
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Inclusion Criteria:
Exclusion Criteria:
Standard exclusion criterion for Phase 1 clinical trial in healthy subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Lomeli | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QuintilesIMS Phase 1 Services, LLC | Kansas City | Kansas | 66211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35963959 | Derived | Nirogi R, Benade V, Goyal VK, Pandey SK, Mohammed AR, Shinde A, Dogiparti D, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of Ropanicant (SUVN-911), a Novel Alpha4 Beta2 Nicotinic Acetylcholine Receptor (alpha4beta2 nAChR) Antagonist, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2022 Sep;42(9):747-762. doi: 10.1007/s40261-022-01189-9. Epub 2022 Aug 13. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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subjects randomized to drug or placebo
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Double blind
| Placebo |
| Drug |
Oral Tablet |
|
| Day 1 and Day 14 |
| Time to reach maximum concentration (Tmax) | Determination of maximum time taken to reach the maximum concentration | Day 1 and Day 14 |
| Terminal half-life (t½) | Elimination rate | Day 1 and Day 14 |
| D001519 |
| Behavior |