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The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 in healthy male subjects following single or multiple ascending doses.
This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-D4010 administered orally once a day to healthy male subjects. The study will be conducted under double blind conditions.
The primary objective is to evaluate the safety and tolerability of SUVN-D4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-D4010,if possible.
The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of SUVN-D4010 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single and Multiple ascending dose | Experimental | Single dose of SUVN-D4010 in healthy male subjects |
|
| Placebo | Placebo Comparator | Placebo in healthy male subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUVN-D4010 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| ECG | Range of Day 1-17 | |
| Physical exams | Range of Day 1-17 | |
| Vitals signs | Range of Day 1-17 | |
| CSSRS (suicidality) | Columbia Suicidal Severity Rating Scale | Range of Day 1-17 |
| Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects | Incidence of Treatment-Emergent Adverse Events, Laboratory parameters | Range of Day 1-17 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau) | Day 1 | |
| Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf) | Day 14 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Dickerson | Research Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Lenexa | Kansas | 66219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33788154 | Derived | Nirogi R, Bhyrapuneni G, Muddana NR, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT4 Partial Agonist, SUVN-D4010, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2021 May;41(5):469-482. doi: 10.1007/s40261-021-01027-4. Epub 2021 Mar 31. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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|
| Maximum observed concentration (Cmax) and time of observation (tmax) |
| Day 1 and Day 14 |
| Oral clearance (CL/F) | Day 1 and Day 14 |
| Accumulation index following multiple dosing of SUVN-D4010 (AI) | Day 14 |
| Elimination half life (t½) | Day 1 and Day 14 |