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

NCT ID: NCT01413932

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HT-2157

Group Type EXPERIMENTAL

HT-2157

Intervention Type DRUG

QD oral dosing

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

QD oral dosing

Interventions

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HT-2157

QD oral dosing

Intervention Type DRUG

Placebo

QD oral dosing

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No clinically relevant abnormalities
* Age 18 to 55 years, inclusive
* Body Mass Index (BMI) of 18.5 to 32 kg/m2


* 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

Exclusion Criteria

\- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs


* Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
* Current and primary Axis I disorder other than MDD
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dart NeuroScience, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Perera, MD

Role: STUDY_DIRECTOR

Dart NeuroScience, LLC

Locations

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Clinical Site

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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HT-2157-107

Identifier Type: -

Identifier Source: org_study_id