ORX142 for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ORX142, an experimental drug, to evaluate its safety and how the body processes it. It involves different groups of healthy adults, including those who are sleep-deprived, to understand the effects of single and multiple doses. Individuals who are generally healthy and free from major health issues, such as heart or sleep problems, are suitable candidates for this trial. As a Phase 1 trial, the research aims to understand 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 taking 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 ORX142 is likely to be safe for humans?
Research has shown that ORX142 is under study to assess its safety and tolerability. So far, 89 healthy adults have taken ORX142, and researchers are examining its effects after single and multiple doses. These early trials test ORX142 on healthy individuals to ensure safety. This step is standard for new treatments to confirm they don't cause harm before testing on larger groups or those with the illness.
No specific information about side effects has been shared, which typically indicates that nothing unexpected or serious has been observed at this stage. It is important to note that ORX142 remains in the early testing phase, so ongoing studies are crucial to confirm its safety.12345Why do researchers think this study treatment might be promising?
ORX142 is unique because it targets the brain's orexin system, which plays a key role in regulating wakefulness and alertness. Unlike current options that often work by promoting wakefulness through stimulating the central nervous system or modulating neurotransmitters like dopamine, ORX142 directly interacts with orexin receptors. This novel mechanism of action could provide a more precise way to manage symptoms related to sleep deprivation without the jittery side effects associated with typical stimulants. Researchers are particularly excited about its potential to deliver quick results, possibly offering relief in a matter of hours rather than days.
What evidence suggests that ORX142 could be effective?
Research has shown that ORX142, a drug targeting specific brain receptors, may improve alertness. In this trial, participants will receive ORX142 in various study parts, including evaluating its effects in healthy older adults, assessing food effects, and studying its impact on acutely sleep-deprived individuals. Studies have found that ORX142 helped people stay awake longer than those who took a placebo, a pill with no active ingredients. This drug works by activating certain brain receptors that control sleep and wakefulness. Early results suggest that ORX142 could help manage sleep deprivation, but further research is needed to confirm these findings.13467
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 80 who experience excessive daytime sleepiness or hypersomnia. The detailed eligibility criteria are not provided, but typically participants should not have other significant health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single and multiple doses of ORX142 to evaluate safety, tolerability, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ORX142
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centessa Pharmaceuticals (UK) Limited
Lead Sponsor