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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HT-2157
Placebo
Sponsored by
Dart NeuroScience, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Volunteers (Part 1)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HT-2157

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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
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)
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

Secondary Outcome Measures

Safety and tolerability of multiple (7-day) doses of HT-2157
To assess the safety and tolerability of multiple (7-day) doses of HT-2157 administered in the fed state to healthy male and female subjects. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events.
Safety and tolerability of multiple (21-day) ascending-doses of HT 2157
To assess the safety and tolerability of multiple (21-day) ascending-doses of HT 2157 administered in the fed state to patients with MDD. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events.
21-day ascending-dose plasma PK profile of HT-2157
To assess the multiple (21-day) ascending-dose plasma PK profile (including AUC, Cmax, Tmax, T1/2, CL/F, Lambda z, VZ/F, RaCmax, RaAUC) of HT-2157 (and its metabolite) administered in the fed state to patients with MDD

Full Information

First Posted
August 4, 2011
Last Updated
November 17, 2015
Sponsor
Dart NeuroScience, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01413932
Brief Title
Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder
Official Title
A Two-part Study: Part 1 is a Multiple-dose (7-day), Open-label Evaluation of the Safety, Tolerability, and Pharmacokinetics of HT-2157 in Healthy Subjects. 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dart NeuroScience, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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-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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers (Part 1), Major Depressive Disorder (Part 2)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HT-2157
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HT-2157
Intervention Description
QD oral dosing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
QD oral dosing
Primary Outcome Measure Information:
Title
7-day plasma PK profile of HT-2157
Description
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
Time Frame
7-day
Title
To assess the brain penetration of HT-2157
Description
To assess the brain penetration (PK [including Cmax, Tmax, AUC if possible] in cerebrospinal fluid [CSF]) of HT-2157 (and its metabolite)
Time Frame
21-days
Title
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
Description
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
Time Frame
21-days
Secondary Outcome Measure Information:
Title
Safety and tolerability of multiple (7-day) doses of HT-2157
Description
To assess the safety and tolerability of multiple (7-day) doses of HT-2157 administered in the fed state to healthy male and female subjects. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events.
Time Frame
7-days
Title
Safety and tolerability of multiple (21-day) ascending-doses of HT 2157
Description
To assess the safety and tolerability of multiple (21-day) ascending-doses of HT 2157 administered in the fed state to patients with MDD. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events.
Time Frame
21-days
Title
21-day ascending-dose plasma PK profile of HT-2157
Description
To assess the multiple (21-day) ascending-dose plasma PK profile (including AUC, Cmax, Tmax, T1/2, CL/F, Lambda z, VZ/F, RaCmax, RaAUC) of HT-2157 (and its metabolite) administered in the fed state to patients with MDD
Time Frame
21-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Perera, MD
Organizational Affiliation
Dart NeuroScience, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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