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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dart NeuroScience, LLC

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