A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Naloxone Hydrochloride, Fentanyl, Sterile Saline, CS-1103.
- Who it may be relevant to
- Registry conditions: Fentanyl Overdose, Fentanyl Poisoning. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Dose of Intravenous CS 1103 Following a Single Intravenous Dose of Fentanyl in Healthy Subjects With Naloxone Blockade
Overview
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
- Drug Naloxone Hydrochloride
Naloxone for intravenous administration - Drug Fentanyl
Fentanyl for intravenous administration - Drug Sterile Saline
Sterile Saline for intravenous administration - Drug CS-1103
CS-1103 for intravenous administration
Primary outcome measures
- Number of participants with CS-1103-related adverse events (AEs) assessed by 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) [Time frame: 3 days plus follow-up on Day 10]
- Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs [Time frame: 3 days plus follow-up on Day 10]
- Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters [Time frame: 3 days plus follow-up on Day 10]
- Time course of CS-1103 blood and urine concentrations [Time frame: 48 hours]
- Time course and magnitude of urine excretion of fentanyl [Time frame: 48 hours]
Secondary outcome measures (2)
- Effect of CS-1103 and fentanyl on QT interval [Time frame: 48 hours]
- Effect of CS-1103 on the naloxone plasma and urine PK, if any [Time frame: 48 hours]
Eligibility criteria
Major Inclusion Criteria:
- Healthy participants aged 18 to 55 years, inclusive;
- Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;
- A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg;
- Females must not be lactating and must have a negative pregnancy test during screening and admission.
Major Exclusion Criteria:
- Estimated glomerular filtration rate <90 mL/min/1.73 m2;
- History of cardiovascular disease;
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- California Clinical Trials Medical Group — Glendale
Identifiers
NCT: NCT07459166 · CS-1103-03 · 5UG3DA059286