Status:
COMPLETED
Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder
Lead Sponsor:
Dart NeuroScience, LLC
Conditions:
Healthy Volunteers (Part 1)
Major Depressive Disorder (Part 2)
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief 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-c...
Detailed 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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01413932
Start Date
July 1 2011
End Date
December 1 2012
Last Update
December 16 2015
Active Locations (1)
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1
Clinical Site
Glendale, California, United States, 91206