Clinical trial NCT06391593: PD, PK, and Safety of ALTO-203 in Patients With MDD
Official title: Double-Blind, Single and Multiple Dose Study to Determine Pharmacodynamic Markers, Pharmacokinetic Parameters, and Safety of ALTO-203 in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Major Depressive Disorder
Anhedonia
Lead sponsor: Alto Neuroscience
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of moderate major depressive disorder (MDD)
* Presence of anhedonia symptoms
* Not taking antidepressant at Screening Visit 2
* Willing to comply with all study assessments and procedures

Exclusion Criteria:

* Evidence of unstable medical condition
* Diagnosed bipolar disorder, psychotic disorder, or dementia
* Concurrent use of prohibited medications
* Current moderate or severe substance use disorder
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Primary outcomes:
measure: 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).
timeFrame: Single-Dose Treatment Period - Pre-Dose, 1.5 hours, 3 hours, and 5 hours on Day 1 at Treatments 1, 2, and 3
measure: 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.
timeFrame: Multi-Dose Treatment Period Day 1 to Day 35
Secondary outcomes:
measure: 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.
timeFrame: Single-Dose Treatment Period Day 1 to Day 21
measure: Multi-Dose Period: To understand the pharmacokinetics (PK) of multi-doses of ALTO-203 in capsule formulation
timeFrame: Multi-Dose Treatment Period Day 1 to Day 35
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Site 4058
state: Arizona
city: Oceanside
country: United States
facility: Site 4082
state: California
city: Torrance
country: United States
facility: Site 4023
state: California
city: Clermont
country: United States
facility: Site 4059
state: Florida
city: Orlando
country: United States
facility: Site 4005
state: Florida
city: Atlanta
country: United States
facility: Site 4031
state: Georgia
city: Pikesville
country: United States
facility: Site 4054
state: Maryland
city: Las Vegas
country: United States
facility: Site 4036
state: Nevada
city: Berlin
country: United States
facility: Site 4022
state: New Jersey
city: Princeton
country: United States
facility: Site 4134
state: New Jersey
city: Westlake
country: United States
facility: Site 4075
state: Ohio
city: Austin
country: United States
facility: Site 4040
state: Texas
city: Houston
country: United States
facility: Site 4072
state: Texas
city: Clinton
country: United States
facility: Site 4007
state: Utah
city: Bellevue
country: United States
facility: Site 4033
state: Washington
Study officials:
References: