Trials Sponsors Conditions Drugs Pricing

Conditions

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

Outcome Measures

Primary Outcomes (3)

7-day plasma PK profile of HT-2157
To assess the multiple dose (7-day) plasma PK profile (including AUC, Cmax, Tmax, T1/2, CL/F, Lambda z, VZ/F) of HT-2157 (and its metabolite) administered in the fed state to healthy male and female subjects
7-day
To assess the brain penetration of HT-2157
To assess the brain penetration (PK \[including Cmax, Tmax, AUC if possible\] in cerebrospinal fluid \[CSF\]) of HT-2157 (and its metabolite)
21-days
PD profile (CSF and peripheral biomarkers, exploratory biologic and pharmacodynamic markers of potential efficacy) of multiple (21-day) doses of HT-2157 patients with MDD
To assess the PD profile (CSF and peripheral biomarkers, exploratory biologic and pharmacodynamic markers of potential efficacy) of multiple (21-day) doses of HT-2157 administered in the fed state to patients with MDD
21-days

Secondary Outcomes (3)

Safety and tolerability of multiple (7-day) doses of HT-2157
7-days
Safety and tolerability of multiple (21-day) ascending-doses of HT 2157
21-days
21-day ascending-dose plasma PK profile of HT-2157
21-days

Study Arms (2)

HT-2157

EXPERIMENTAL

Drug: HT-2157

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HT-2157Drug

QD oral dosing

HT-2157

PlaceboDrug

QD oral dosing

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

No clinically relevant abnormalities
Age 18 to 55 years, inclusive

Sponsors & Collaborators

Dart NeuroScience, LLC
Industrylead

Study Sites (1)

Clinical Site

Glendale, California, 91206, United States

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

Philip Perera, MD
Dart NeuroScience, LLC
STUDY DIRECTOR

Enrollment

26 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 4, 2011

First Posted

August 10, 2011

Study Start

July 2011

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (2)

HT-2157

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (2)

HT-2157

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations