The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of four single, increasing doses of CS-1103, given by intravenous (IV) infusion in otherwise healthy, non-treatment seeking participants with methamphetamine use disorder in the presence of a clinically relevant dose of methamphetamine HCl (30 mg IV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Methamphetamine HCl for intravenous administration
Sterile Saline for intravenous administration
CS-1103 for intravenous administration
California Clinical Trials Medical Group
Glendale, California, United States
RECRUITINGNumber of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
Physical examinations
Time frame: 3 days plus follow-up on Day 10
Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)
Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted.
Time frame: 3 days plus follow-up on Day 10
Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs
Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
Time frame: 3 days plus follow-up on Day 10
Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters
Clinical chemistry, hematology, coagulation, and urinalysis
Time frame: 3 days plus follow-up on Day 10
Time course and magnitude of urine excretion of methamphetamine
Measurement of concentration of methamphetamine in urine
Time frame: 48 hours
Time course of CS-1103 blood and urine concentrations
Measurement of plasma and urine concentrations of CS-1103
Time frame: 48 hours
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