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The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-G3031 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-G3031 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-G3031 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-G3031, 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-G3031 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose | Placebo Comparator | Single dose of SUVN-G3031or placebo in healthy male subjects |
|
| Multiple ascending dose | Placebo Comparator | Multiple doses of SUVN-G3031 or placebo in healthy male subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUVN-G3031 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects | Safety variables - Adverse events, vital signs, electrocardiograms, telemetry, physical examination, and clinical laboratory assessments. | Range of Day 1-19 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the SUVN-G3031 plasma concentration-time curve in a dosing interval (AUC0-tau) | Day 1 | |
| Area under the SUVN-G3031 plasma concentration-time curve from zero to infinity (AUC0-inf) | Day 14 |
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Inclusion Criteria:
• Healthy male aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murtaugh Thomas, MD | Senior Medical Research Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles | Overland Park | Kansas | 66211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32399853 | Derived | Nirogi R, Mudigonda K, Bhyrapuneni G, Muddana NR, Shinde A, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses. Clin Drug Investig. 2020 Jul;40(7):603-615. doi: 10.1007/s40261-020-00920-8. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000705512 | samelisant |
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| Drug |
|
| Maximum observed concentration (Cmax) and time of observation (tmax) | Day 1 and Day 14 |
| Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination half life (t½) | Day 1 and Day 14 |
| Accumulation index following multiple dosing of SUVN-G3031 (AI) | Day 14 |