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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

August 4, 2011
March 12, 2013
July 2011
December 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01413932 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder
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

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

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Healthy Volunteers (Part 1)
  • Major Depressive Disorder (Part 2)
  • Drug: HT-2157
    QD oral dosing
  • Drug: Placebo
    QD oral dosing
  • Experimental: HT-2157
    Intervention: Drug: HT-2157
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01413932
HT-2157-107
No
Dart NeuroScience, LLC
Dart NeuroScience, LLC
Not Provided
Study Director: Philip Perera, MD Dart NeuroScience, LLC
Dart NeuroScience, LLC
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP