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The goal of this clinical trial is to determine the pharmacodynamic effects of ALTO-203 in patients with MDD in a randomized, placebo-controlled, single-dose crossover treatment period. Additionally, safety, tolerability, and PK will be assessed in a subsequent randomized placebo-controlled multi-dose parallel-group treatment period of 28 days.
Participants will complete subjective response questionnaires and perform cognitive tasks during the single-dose period, in which participants will receive ALTO-203 25 μg and 75 μg, as well as placebo. During the multiple-dose period, participants will receive either ALTO-203 25 μg, 75 μg , or placebo. Safety will be assessed over the single dose and 28-day multiple dose periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTO-203 25 μg | Experimental | Drug: ALTO-203 25 μg Single-Dose Treatment Period: Single Dose, ALTO-203 25 μg Multi-Dose Treatment Period: ALTO-203 25 μg, administered orally, once daily for 28 days |
|
| ALTO-203 75 μg | Experimental | Drug: ALTO-203 75 μg Single-Dose Treatment Period: Single Dose, ALTO-203 75 μg Multi-Dose Treatment Period: ALTO-203 75 μg, administered orally, once daily for 28 days |
|
| Placebo | Placebo Comparator | Drug: Placebo Single-Dose Treatment Period: Single Dose, Placebo Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTO-203 25 μg | Drug | Active, ALTO-203 25 μg |
| |
| ALTO-203 75 μg |
| Measure | Description | Time Frame |
|---|---|---|
| Single Dose Period: To evaluate pharmacodynamic measures in patients with MDD after single doses of 25 μg ALTO-203, 75 μg ALTO-203, and placebo as measured by the alertness and mood components of the Bond-Lader Visual Analog Scale (BL-VAS). | The Bond-Lader Visual Analogue Scale (BL-VAS) is used to measure the effects of drugs on the participants' mood. It consists of 16 VAS measurements of different mood state. For each question, the participants will rate their feelings at the time of assessment by indicating the point on the 10 cm line which best represents their mood. Each item is scored by measuring the position relative to the left-hand end of the line. The combined domains of alertness and mood will be assessed for the primary endpoint. | Single-Dose Treatment Period - Pre-Dose, 1.5 hours, 3 hours, and 5 hours on Day 1 at Treatments 1, 2, and 3 |
| Multi-Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the multi-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo. | Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs. | Multi-Dose Treatment Period Day 1 to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Single Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the single-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo. | Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs. | Single-Dose Treatment Period Day 1 to Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 4058 | Tucson | Arizona | 85704 | United States | ||
| Site 4082 |
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The study will consist of two treatment periods. The initial Single-Dose Treatment Period is a randomized, double-blind, placebo-controlled 3-way crossover design with oral administration of a single dose of ALTO-203 25 μg, ALTO-203 75 μg, and matching placebo. In the subsequent Multi-Dose Parallel-Group Treatment Period, participants will receive ALTO-203 25 μg, ALTO-203 75 μg, or matching placebo randomized 1:1:1 for a total of 28 days.
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| Drug |
Active, ALTO-203 75 μg |
|
| Placebo | Drug | Comparator, Placebo-to-match |
|
| Multi-Dose Period: To understand the pharmacokinetics (PK) of multi-doses of ALTO-203 in capsule formulation |
Bioanalysis of plasma samples and observed plasma concentrations of ALTO-203 after multiple days of dosing. |
| Multi-Dose Treatment Period Day 1 to Day 35 |
| Oceanside |
| California |
| 92056 |
| United States |
| Site 4023 | Torrance | California | 90504 | United States |
| Site 4059 | Clermont | Florida | 34711 | United States |
| Site 4005 | Orlando | Florida | 32801 | United States |
| Site 4031 | Atlanta | Georgia | 30030 | United States |
| Site 4054 | Pikesville | Maryland | 21208 | United States |
| Site 4036 | Las Vegas | Nevada | 89121 | United States |
| Site 4022 | Marlton | New Jersey | 08053 | United States |
| Site 4134 | Princeton | New Jersey | 08540 | United States |
| Site 4075 | Westlake | Ohio | 44145 | United States |
| Site 4040 | Austin | Texas | 78737 | United States |
| Site 4072 | Houston | Texas | 77081 | United States |
| Site 4007 | Clinton | Utah | 84015 | United States |
| Site 4033 | Bellevue | Washington | 98007 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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