Naloxone Hydrochloride: Naloxone for intravenous administration
Fentanyl: Fentanyl for intravenous administration
Sterile Saline: Sterile Saline for intravenous administration
CS-1103: CS-1103 for intravenous administration
Study summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of fentanyl (200 μg, IV), with naloxone blockade (400 μg, IV).
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Major Inclusion Criteria:
1. Healthy participants aged 18 to 55 years, inclusive;
2. Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;
3. A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg;
4. Females must not be lactating and must have a negative pregnancy test during screening and admission.
Major Exclusion Criteria:
1. Estimated glomerular filtration rate \<90 mL/min/1.73 m2;
2. History of cardiovascular disease;
3. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
Primary outcome measure(s)
Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations — 3 days plus follow-up on Day 10 Physical examinations
Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs) — 3 days plus follow-up on Day 10 Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted
Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs — 3 days plus follow-up on Day 10 Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters — 3 days plus follow-up on Day 10 Clinical chemistry, hematology, coagulation, and urinalysis
Time course of CS-1103 blood and urine concentrations — 48 hours Measurement of plasma and urine concentrations of CS-1103
Time course and magnitude of urine excretion of fentanyl — 48 hours Measurement of concentration of fentanyl in urine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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