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Tests treatment safety and results for Fentanyl Overdose
Official title A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
ClinicalTrials.gov ID: NCT07459166
What this study is testing
What is Naloxone Hydrochloride?
Naloxone Hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for fentanyl overdose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Major
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.