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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dart NeuroScience, LLC
ClinicalTrials.gov Identifier:
NCT01413932
First received: August 4, 2011
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Volunteers (Part 1)
Major Depressive Disorder (Part 2)
 Drug: HT-2157
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Dart NeuroScience, LLC:

Primary Outcome Measures:
  • 7-day plasma PK profile of HT-2157 [ Time Frame: 7-day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 21-days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 21-days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7-days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 21-days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 21-days ] [ Designated as safety issue: No ]
    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


Enrollment: 26
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HT-2157 Drug: HT-2157
QD oral dosing
Placebo Comparator: Placebo Drug: Placebo
QD oral dosing

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413932

Locations
United States, California
Clinical Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Dart NeuroScience, LLC
Investigators
Study Director: Philip Perera, MD Dart NeuroScience, LLC
  More Information

No publications provided

Responsible Party: Dart NeuroScience, LLC
ClinicalTrials.gov Identifier: NCT01413932     History of Changes
Other Study ID Numbers: HT-2157-107
Study First Received: August 4, 2011
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013