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CSX-1004 Effects on Fentanyl-Induced Respiratory Depression
EU CTIS ID: 2025-524133-33-00
What this study is testing
To evaluate the effect of CSX-1004 Injection on fentanyl-induced respiratory depression in healthy adult participants and participants with OUD, as determined by change in isohypercapnic minute ventilation (MV).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must provide written informed consent prior to the initiation of any protocol-specific procedures.
- Male and female adults, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) within 18.0 to 32.0 kg/m², inclusive (minimum weight of at least 50.0 kg).
- Must be medically stable, as determined by medical history, physical examination, ECG, and vital signs at Screening
- Negative urine drug screen for fentanyl at Screening.
- Is willing and able to comply with the study requirements, including clinic confinement and blood sampling.
You likely can't join if
- History or presence of any clinically significant psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening.
- Part A: History of or currently meets the criteria for a diagnosis of substance use disorder according to DSM-5-TR criteria for any substances (excluding caffeine).
- Part B: Currently meets the criteria for a diagnosis of substance use disorder according to DSM-5-TR criteria for any substances, excluding opioids, caffeine, or nicotine.
- Part B: History of or currently meets the criteria for a diagnosis of severe opioid use disorder.
- Requires concomitant treatment with prohibited medications that cannot be safely discontinued prior to first drug administration.
See the full eligibility criteria
- Must provide written informed consent prior to the initiation of any protocol-specific procedures.
- Male and female adults, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) within 18.0 to 32.0 kg/m², inclusive (minimum weight of at least 50.0 kg).
- Must be medically stable, as determined by medical history, physical examination, ECG, and vital signs at Screening
- Negative urine drug screen for fentanyl at Screening.
- Is willing and able to comply with the study requirements, including clinic confinement and blood sampling.
- Part B: Diagnosis of mild or moderate opioid use disorder (DSM-5-TR) and self-reported daily opioid use, defined as daily oral MME doses ≥30 to ≤120 mg for at least 3 months.
- History or presence of any clinically significant psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening.
- Part A: History of or currently meets the criteria for a diagnosis of substance use disorder according to DSM-5-TR criteria for any substances (excluding caffeine).
- Part B: Currently meets the criteria for a diagnosis of substance use disorder according to DSM-5-TR criteria for any substances, excluding opioids, caffeine, or nicotine.
- Part B: History of or currently meets the criteria for a diagnosis of severe opioid use disorder.
- Requires concomitant treatment with prohibited medications that cannot be safely discontinued prior to first drug administration.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.