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

NCT01413932 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-12-16

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

HT-2157

QD oral dosing

DRUG

Placebo

QD oral dosing

Sponsors & Collaborators

  • Dart NeuroScience, LLC

    lead INDUSTRY

Principal Investigators

  • Philip Perera, MD · Dart NeuroScience, LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413932 on ClinicalTrials.gov