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

Dart NeuroScience

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy Volunteers (Part 1)

Major Depressive Disorder (Part 2)

Treatments

Drug: HT-2157

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01413932

HT-2157-107

Details and patient eligibility

About

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

Full description

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

Enrollment

26 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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