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The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses at increasing dose levels, 2) to determine the pharmacokinetic (PK) profile after single and multiple ascending oral doses, 3) to investigate the effects of food on SUVN-I6107 pharmacokinetics and 4) to evaluate the pharmacodynamic (PD) effects of single and multiple ascending oral doses of SUVN-I6107 on quantitative electroencephalogram (qEEG) and event-related potential (ERP) assessments.
This research study is a randomized, single-center, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD), first-in-human study in healthy participants.
This study consist of 2 segments: Segment 1 will be the SAD portion and Segment 2 will be the MAD portion.
Segment 1 will include up to 5 sequential cohorts. Up to 40 healthy male or female subjects, ages 18 - 45 years (inclusive) old at screening will be enrolled.
Segment 2 will include up to 3 sequential cohorts. The dosing will be administered for 14 consecutive days. Up to 24 healthy male or female subjects, ages 50 to 80 years (inclusive) old at screening will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose | Experimental | single ascending doses administered orally |
|
| Multiple Ascending Dose | Experimental | multiple ascending doses administered orally for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUVN-I6107 | Drug | SUVN-I6107 Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Number of participants with adverse events (AE), discontinuations due to AE or serious adverse event [SAE], and withdrawals from the study due to AE. | From Day 1 to Day 11 (Segment 1) and from Day 1 to Day 24 (Segment 2) |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Descriptive statistics of QTcF for observed values and changes from baseline will be summarized at each scheduled time point. | From Baseline to Day 11 (Segment 1) and to Day 24 (Segment 2) |
| Number of Participants With Clinically Significant Changes in Blood Pressure | From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2) | |
| Number of Participants With Clinically Significant Changes in Pulse Rate | From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2) | |
| Number of Participants With Clinically Significant Changes in Body Temperature | From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2) | |
| Number of Participants With Clinically Significant Changes in Respiration Rate | From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2) | |
| Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score | The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) | SUVN-I6107 concentrations levels will be assessed after single and multiple ascending oral doses. | Day 1 and Day 14 |
| Maximum observed concentration (Cmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative electroencephalogram (qEEG) | Change in absolute quantitative electroencephalogram (qEEG) power from predose to postdose. | Day 1 (Segment 1); Day 7 and Day 12 (Segment 2) |
| Latency for parameter from the Active, Auditory Oddball Event-related potential (ERP) test |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | San Antonio | Texas | 78209 | United States |
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| Placebo |
| Drug |
A look-alike tablet with no active ingredient. |
|
| From baseline to Day 24 (Segment 2) |
SUVN-I6107 maximum observed concentration will be assessed after single and multiple ascending oral doses.
| Day 1 and Day 14 |
| Time to reach maximum concentration (Tmax) | Time to reach maximum concentration will be assessed after single and multiple ascending oral doses. | Day 1 and Day 14 |
| Terminal half-life (t½) | SUVN-I6107 elimination rate will be assessed after single and multiple ascending oral doses. | Day 1 and Day 14 |
Change in latency (in milliseconds) for the P300 parameter from the Active, Auditory Oddball ERP test from predose to postdose. |
| Day 1 (Segment 1); Day 7 and Day 12 (Segment 2) |