NCT05025397

A Study of Danavorexton in Anesthetized Adults

A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Danavorexton in Anesthetized Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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 anesthetized adults. On Day 1, participants will receive a single intravenous (IV) infusion of danavorexton or a placebo after participants have been anesthetized for about 40 minutes. Clinic doctors will arrange a follow-up visit by phone or video on Day 7.

Detailed description

The drug being tested in this study is called danavorexton or TAK-925. Danavorexton is being tested to evaluate safety, tolerability, PK, and pharmacodynamics (PD) in healthy participants. The study will enroll approximately 28 participants. This study consists of 4 cohorts: Cohorts A1, A2, A3 and P (healthy participants aged 18 to 55 years). In each of the 4 cohorts, participants will be randomly assigned (by chance) to receive danavorexton or danavorexton placebo-matching -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Cohort A1: Danavorexton Low Dose * Cohort A2: Danavorexton Middle Dose * Cohort A3: Danavorexton High Dose * Cohort P: Danavorexton TBD Additional optional cohorts may be added to the study based on the outcomes from the mandatory cohorts described above. This trial will be conducted in the United States. The overall time to participate in this study is 37 days including screening period, residential period, and safety follow up period. A follow-up visit by phone or video will be conducted on Day 7.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Danavorexton	Danavorexton intravenous infusion.
DRUG	Danavorexton Placebo	Danavorexton placebo-matching intravenous infusion.
DRUG	Propofol	Propofol intravenous bolus.
DRUG	Sevoflurane	Sevoflurane inhalation.
DRUG	Propofol	Propofol intravenous infusion.

Timeline

• Start date: 2021-09-28
• Primary completion: 2022-03-08
• Completion: 2022-03-08
• First posted: 2021-08-27
• Last updated: 2022-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study