Danavorexton for Anesthesia in Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new drug, danavorexton, in adults under anesthesia. Researchers aim to observe how danavorexton interacts with anesthetics commonly used during surgeries. Participants will receive either danavorexton or a placebo (a substance with no active drug) through an IV while anesthetized. This trial may suit healthy adults who do not smoke and have regular sleep habits. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that danavorexton is likely to be safe for humans?
Research has shown that danavorexton has been tested for safety in earlier studies. One study found that 64% of patients experienced mild side effects after starting the treatment, with 48% directly linked to it. Another study examined danavorexton's effects on breathing in healthy men and found the treatment generally well-tolerated. While some side effects occurred, they were mild and manageable. These findings suggest that danavorexton is fairly safe, though it might cause some mild side effects.12345
Why do researchers think this study treatment might be promising?
Danavorexton is unique because it offers a potentially novel approach to managing anesthesia in adults. Unlike standard anesthetics like propofol or sevoflurane, Danavorexton is administered intravenously and may provide an alternative mechanism of action by potentially affecting different receptors or pathways involved in maintaining anesthesia. Researchers are particularly excited about Danavorexton because it might enhance safety and tolerability compared to existing anesthetics, especially in terms of dose flexibility and reduced side effects. Plus, its ability to be fine-tuned across different dosing cohorts could allow for more personalized anesthetic care.
What evidence suggests that danavorexton could be an effective treatment when administered with anesthetics?
Research has shown that danavorexton, a drug that activates certain brain receptors, can help people wake up faster from anesthesia. Studies have also found that it reduces drowsiness caused by painkillers like fentanyl and improves breathing issues linked to these drugs. In this trial, participants will receive different doses of danavorexton—low, middle, and high—to evaluate its effects. Specifically, high doses have significantly reduced drowsiness. These findings suggest that danavorexton may help people recover more quickly from anesthesia, making it a promising option for those undergoing surgery.678910
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous infusion of danavorexton or placebo after being anesthetized for about 40 minutes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Danavorexton
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Danavorexton dose to be decided (TBD) or danavorexton placebo-matching infusion, once, intravenously on Day 1 in healthy adult participants with intravenous propofol as induction and primary maintenance anesthetic. Dose of danavorexton will be based on the review of observed safety and tolerability data and pharmacokinetic (PK) data of previous cohorts.
Danavorexton high dose or danavorexton placebo-matching infusion, single, intravenously on Day 1 in healthy adult participants with intravenous propofol as induction anesthetic and inhaled sevoflurane as the primary maintenance anesthetic.
Danavorexton middle dose or danavorexton placebo-matching infusion, once, intravenously on Day 1 in healthy adult participants with intravenous propofol as induction anesthetic and inhaled sevoflurane as the primary maintenance anesthetic.
Danavorexton low dose or danavorexton placebo-matching infusion, once, intravenously on Day 1 in healthy adult participants with intravenous propofol as induction anesthetic and inhaled sevoflurane as the primary maintenance anesthetic.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
Citations
Danavorexton (TAK-925): an orexin receptor 2 agonist as a ...
Collectively, these data demonstrate that danavorexton enhanced recovery from anaesthesia and from opioid-induced sedation, and reduced opioid-induced ...
Effects of the orexin receptor 2 agonist danavorexton on ...
Danavorexton promoted recovery from anaesthesia and fentanyl-induced sedation, and antagonised fentanyl-induced respiratory depression without compromising ...
Effects of the orexin receptor 2 agonist danavorexton on ...
Conclusions: Danavorexton promoted recovery from anaesthesia and fentanyl-induced sedation, and antagonised fentanyl-induced respiratory depression without ...
Effects of the orexin receptor 2 agonist danavorexton on ...
Conclusions: Danavorexton promoted recovery from anaesthesia and fentanyl-induced sedation, and antagonised fentanyl-induced respiratory ...
TAK-925 (Danavorexton), an Orexin Receptor 2 Agonist ...
High-dose danavorexton significantly decreased sedation on a visual analog scale (-29.7 [95% CI, -54.1 to -5.3] mm; P < 0.001) and the Richmond ...
Safety and pharmacodynamics of a single infusion ...
These findings show that danavorexton can improve subjective and objective measures of EDS in patients with OSA and residual EDS despite adequate CPAP use.
TAK-925 (Danavorexton), an Orexin Receptor 2 Agonist ...
This study assessed the safety and effect of danavorexton on ventilation in healthy men in an established remifentanil-induced respiratory depression model.
Safety and pharmacodynamics of a single infusion ...
Among 25 randomized patients, 16 (64.0%) had treatment-emergent adverse events (TEAEs) and 12 (48.0%) had TEAEs considered related to treatment, all mild or ...
NCT05025397 | A Study of Danavorexton in Anesthetized ...
The aims of the study are: to assess the safety profile of danavorexton when it is administered with anesthetics. to learn what effect danavorexton has on ...
Danavorexton in healthy volunteers receiving an opioid
Some side effects of remifentanil include: blurred vision, chest pain, confusion, dizziness or feeling lightheaded when getting up, irregular ...
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