A Study of Danavorexton in Anesthetized Adults

Overseen By Takeda Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must not be taking: Immunotherapy, Cannabis

Disqualifiers: Malignant hyperthermia, Alcohol, Caffeine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

28 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Inclusion Criteria

Current non-smoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before the administration of the study drug.

Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 32 kilogram per square meter (kg/m^2) at the screening visit.

Has regular sleep-wake habits (example, routinely spends 6.5 to 9 hours in bed nightly).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous infusion of danavorexton or placebo after being anesthetized for about 40 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

1 visit (phone or video)

Treatment Details

Interventions

• Danavorexton

Participant Groups

Group I: Cohort P: Danavorexton TBD Experimental Treatment 3 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 Dose Experimental Treatment 4 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 Dose Experimental Treatment 4 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 Dose Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

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