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 up to 5 years

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

~1520