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Hypoxic ventilatory response (HVR): Effect of Esketamine
EU CTIS ID: 2023-504229-37-00
What this study is testing
Part 1 Effect of esketamine on the sustained hypoxic ventilatory response with hypoxia lasting 25 min. Part 2 Reversal of remifentanil-induced depression of the acute hypoxic ventilatory response by esketamine with hypoxia lasting 2 times 7 min (once at low and once at high CO2 levels)
- Therapeutic use (Phase IV)
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
- aged 18-45 years
- • Body mass index 19-30 kg/m2;
- • Able to read and understand the subject information.
You likely can't join if
- • A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •• A history of clinically significant (as deemed by the investigators) medical or psychiatric disease. These include: clinically significant illness or disease (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or any clinically significant abnormal symptom or organ impairment, as judged by the investigator, found by medical history, physical examinations or vital signs at screening;
- • any allergy to food or medication;
- • weekly alcohol intake of more than 3 units/day or more than 21 units/week in women and 5 units/day and 35 units/week in men;
- • pregnancy or lactation;
- • women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative urine pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug. By contraception we mean for women: intrauterine device (IUD), diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation. Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms.
See the full eligibility criteria
- aged 18-45 years
- • Body mass index 19-30 kg/m2;
- • Able to read and understand the subject information.
- • A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •• A history of clinically significant (as deemed by the investigators) medical or psychiatric disease. These include: clinically significant illness or disease (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or any clinically significant abnormal symptom or organ impairment, as judged by the investigator, found by medical history, physical examinations or vital signs at screening;
- • any allergy to food or medication;
- • weekly alcohol intake of more than 3 units/day or more than 21 units/week in women and 5 units/day and 35 units/week in men;
- • pregnancy or lactation;
- • women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative urine pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug. By contraception we mean for women: intrauterine device (IUD), diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation. Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms.
- • participation in an investigational drug trial in the 3 months before the current study;
- • illicit drug use in the 30 days before the current study;
- • a positive drug urine dipstick on the screening or study days.
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.