The purpose of this study is to measure the amount of ketamine in blood over time in subjects diagnosed with Major Depressive Disorder (MDD) and explore the anti-depressive effects of ketamine delivered by transdermal patch.
SHX-C301 is a Phase 1, first in human, single-blind, multi-center clinical study to evaluate the pharmacokinetics (PK), safety and antidepressant effects of SHX-001 transdermal patch low dose delivered based on prediction and high dose delivered based on the estimation from the low dose PK in subjects with MDD and sub-optimally controlled by standard of care.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
Clinical Research Site
Gaithersburg, Maryland, United States
Clinical Research Site
Boston, Massachusetts, United States
Clinical Research Site
Dayton, Ohio, United States
Pharmacokinetics of SHX-001 (Cmax)
Maximum observed plasma concentration
Time frame: 1 week
Pharmacokinetics of SHX-001 (Tmax)
Time of maximum observed plasma concentration
Time frame: 1 week
Pharmacokinetics of SHX-001 (T1/2)
Apparent terminal half-life
Time frame: 1 week
Anti-depressive effects of SHX-001
Antidepressant effects will be explored by assessing changes in depression assessments (clinician and self-rated)
Time frame: 1 week
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