Fentanyl Overdose, Fentanyl Poisoning
Conditions
Brief 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).
Interventions
Naloxone for intravenous administration
DRUGFentanyl
Fentanyl for intravenous administration
DRUGSterile Saline
Sterile Saline for intravenous administration
DRUGCS-1103
CS-1103 for intravenous administration
Sponsors
Clear Scientific, Inc.
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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 \<60 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of CS-1103 and fentanyl on QT interval | 48 hours | Concentration-QT correlation performed on baseline-corrected QTcF time-matched with PK for fentanyl and CS-1103 in plasma |
| Effect of CS-1103 on the naloxone plasma and urine PK, if any | 48 hours | Measurement of standard urine and plasma PK parameters between placebo and CS-1103 treated participants |
Countries
United States
Contacts
CONTACTAnna Del Rosario, B.S.
CONTACTPiercen Oliver, Ph.D.
PRINCIPAL_INVESTIGATORXinhua Li, Ph.D.
Clear Scientific, Inc.
Outcome results
None listed