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Danavorexton for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
Awards & highlights

Summary

This trial tests the safety and effects of danavorexton, a drug given to healthy adults, when used with anesthetics. Researchers want to see if it is safe and how it behaves in the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE)
Secondary outcome measures
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Danavorexton
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Danavorexton
Ceoi: Observed Plasma Concentration at the end of Infusion for Danavorexton

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort P: Danavorexton TBDExperimental Treatment3 Interventions
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.
Group II: Cohort A3: Danavorexton High DoseExperimental Treatment4 Interventions
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.
Group III: Cohort A2: Danavorexton Middle DoseExperimental Treatment4 Interventions
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.
Group IV: Cohort A1: Danavorexton Low DoseExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sevoflurane
2016
Completed Phase 4
~1260
Propofol
2017
Completed Phase 4
~1530
Danavorexton Placebo
2021
Completed Phase 1
~30
Danavorexton
2022
Completed Phase 1
~50

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TakedaLead Sponsor
1,213 Previous Clinical Trials
4,187,125 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,230 Previous Clinical Trials
501,062 Total Patients Enrolled
~7 spots leftby Sep 2025
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