Title
Ketamine for Major Depressive Disorder
A Phase 1 Pharmacokinetics and Pharmacodynamics of Ketamine Transdermal Drug Delivery System in Subjects With Sub-Optimally Responsive Major Depressive Disorders
Phase
Phase 1Lead Sponsor
Shenox Pharmaceuticals, LLCStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Major Depressive DisorderIntervention/Treatment
SHX-001 Active low dose SHX-001 Active High dose ...Study Participants
14The 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.
transdermal patch
Inclusion Criteria: Present a current depressive episode of at least 8 weeks Have a body mass index (BMI) of 18-35 kg/m2 (inclusive) at screening Agree to use adequate methods of contraception during the study (and for X days after discharge) Exclusion Criteria: A history of alcohol consumption exceeding 14 drinks/week within the 5 years before study entry. Use of prescription or non-prescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study medication except ongoing stable dose of antidepressant. Treatment with any investigational drug, use of any known CYP3A4 enzyme-inducing/inhibiting agents (e.g., barbiturates, phenothiazines, cimetidine, St. John's Wort) or herbal supplements within 7 days prior to the first dose of study medication A history of drug abuse or dependence within 180 days of screening A febrile illness within 5 days prior to the first dose of study medication. A known hypersensitivity to ketamine A history of use ketamine for Major Depressive Disorder and did not respond to ketamine Recent use of ketamine in any formulation for any indication (within 4 weeks prior to screening)
