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

NCT01413932 | Completed Phase 1

• 1 other identifier: HT-2157-107
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

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-2157 DRUG

QD oral dosing

HT-2157

Placebo DRUG

QD oral dosing

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Dart NeuroScience, LLC: lead

Study Sites (1)

Clinical Site

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Philip Perera, MD

  Dart NeuroScience, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 16, 2015

Record last verified: 2015-11

Locations

US (1)