Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder

Dart NeuroScience, LLC26 enrolled

Overview

This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability, and pharmacokinetics of HT-2157 in healthy normal volunteers Part 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in patients with major depressive disorder

This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability, and pharmacokinetics of HT-2157 administered for 7-days in healthy normal volunteers Part 2 is a randomized, double-blind, placebo-controlled, multiple ascending-dose evaluation of the safety, tolerability, pharmacokinetics of HT-2157 administered for 21-days in patients with major depressive disorder. The primary objective of Part 2 is to assess the CNS penetration of HT-2157 in cerebrospinal fluid. In addition, the potential activity of HT-2157 in this patient population may be assessed using exploratory biologic and pharmacodynamic markers of potential efficacy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers (Part 1)Major Depressive Disorder (Part 2)

Interventions

HT-2157DRUG

QD oral dosing

PlaceboDRUG

QD oral dosing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main Inclusion Criteria (Part 1) * No clinically relevant abnormalities * Age 18 to 55 years, inclusive * Body Mass Index (BMI) of 18.5 to 32 kg/m2 Main Inclusion Criteria (Part 2) * No clinically relevant abnormalities * Age 18 to 55 years, inclusive * Body Mass Index (BMI) of 18.5 to 32 kg/m2 * Mild-to-Moderate major depressive disorder Main Exclusion Criteria (Part 1) \- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs Main Exclusion Criteria (Part 2) * Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs * Current and primary Axis I disorder other than MDD

Locations (1)

Clinical Site

Glendale, California, United States

Outcomes

Primary Outcomes

7-day plasma PK profile of HT-2157

To assess the multiple dose (7-day) plasma PK profile (including AUC, Cmax, Tmax, T1/2, CL/F, Lambda z, VZ/F) of HT-2157 (and its metabolite) administered in the fed state to healthy male and female subjects

Time frame: 7-day

To assess the brain penetration of HT-2157

To assess the brain penetration (PK \[including Cmax, Tmax, AUC if possible\] in cerebrospinal fluid \[CSF\]) of HT-2157 (and its metabolite)

Time frame: 21-days

PD profile (CSF and peripheral biomarkers, exploratory biologic and pharmacodynamic markers of potential efficacy) of multiple (21-day) doses of HT-2157 patients with MDD

To assess the PD profile (CSF and peripheral biomarkers, exploratory biologic and pharmacodynamic markers of potential efficacy) of multiple (21-day) doses of HT-2157 administered in the fed state to patients with MDD

Time frame: 21-days

Secondary Outcomes

Safety and tolerability of multiple (7-day) doses of HT-2157

To assess the safety and tolerability of multiple (7-day) doses of HT-2157 administered in the fed state to healthy male and female subjects. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events.

Time frame: 7-days

Safety and tolerability of multiple (21-day) ascending-doses of HT 2157

To assess the safety and tolerability of multiple (21-day) ascending-doses of HT 2157 administered in the fed state to patients with MDD. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events.

Time frame: 21-days

Data from ClinicalTrials.gov

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