Clinical trial NCT01413932: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers (Part 1)
Major Depressive Disorder (Part 2)
Lead sponsor: Dart NeuroScience, LLC
Sponsor class: INDUSTRY
First posted: 2011-08-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: 7-day plasma PK profile of HT-2157
timeFrame: 7-day
measure: To assess the brain penetration of HT-2157
timeFrame: 21-days
measure: 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
timeFrame: 21-days
Secondary outcomes:
measure: Safety and tolerability of multiple (7-day) doses of HT-2157
timeFrame: 7-days
measure: Safety and tolerability of multiple (21-day) ascending-doses of HT 2157
timeFrame: 21-days
measure: 21-day ascending-dose plasma PK profile of HT-2157
timeFrame: 21-days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Clinical Site
state: California
Study officials:
affiliation: Dart NeuroScience, LLC
name: Philip Perera, MD
role: STUDY_DIRECTOR
References: