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A Two-part Study: Part 1 is a Multiple-dose (7-day), Open-label Evaluation of the Safety, Tolerability, and Pharmacokinetics of HT-2157 in Healthy Subjects. Part 2 is a Randomized, Double-blind, Placebo-controlled, Multiple (21-day) Ascending-dose Evaluat

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Conditions:		Healthy Volunteers (Part 1) - Major Depressive Disorder (Part 2)
Purpose:		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
Study Summary:		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
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
NCT ID:		NCT01413932
Primary Contact:		Study Director Philip Perera, MD Dart NeuroScience, LLC
Backup Contact:		N/A
Location Contact:		Glendale, California 91206 United States There is no listed contact information for this specific location. Site Status: N/A

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