A Study of Danavorexton in Anesthetized Adults

NCT ID: NCT05025397

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2022-03-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cohort A1: Danavorexton Low Dose

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.

Group Type: EXPERIMENTAL

Danavorexton

Intervention Type: DRUG

Danavorexton intravenous infusion.

Danavorexton Placebo

Intervention Type: DRUG

Danavorexton placebo-matching intravenous infusion.

Propofol

Intervention Type: DRUG

Propofol intravenous bolus.

Sevoflurane

Intervention Type: DRUG

Sevoflurane inhalation.

Cohort A2: Danavorexton Middle Dose

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 Type: EXPERIMENTAL

Danavorexton

Intervention Type: DRUG

Danavorexton intravenous infusion.

Danavorexton Placebo

Intervention Type: DRUG

Danavorexton placebo-matching intravenous infusion.

Propofol

Intervention Type: DRUG

Propofol intravenous bolus.

Sevoflurane

Intervention Type: DRUG

Sevoflurane inhalation.

Cohort A3: Danavorexton High Dose

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 Type: EXPERIMENTAL

Danavorexton

Intervention Type: DRUG

Danavorexton intravenous infusion.

Danavorexton Placebo

Intervention Type: DRUG

Danavorexton placebo-matching intravenous infusion.

Propofol

Intervention Type: DRUG

Propofol intravenous bolus.

Sevoflurane

Intervention Type: DRUG

Sevoflurane inhalation.

Cohort P: Danavorexton TBD

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 Type: EXPERIMENTAL

Danavorexton

Intervention Type: DRUG

Danavorexton intravenous infusion.

Danavorexton Placebo

Intervention Type: DRUG

Danavorexton placebo-matching intravenous infusion.

Propofol

Intervention Type: DRUG

Propofol intravenous infusion.

Interventions

Danavorexton

Danavorexton intravenous infusion.

Intervention Type: DRUG

Danavorexton Placebo

Danavorexton placebo-matching intravenous infusion.

Intervention Type: DRUG

Propofol

Propofol intravenous bolus.

Intervention Type: DRUG

Sevoflurane

Sevoflurane inhalation.

Intervention Type: DRUG

Propofol

Propofol intravenous infusion.

Intervention Type: DRUG

Other Intervention Names

TAK-925

Eligibility Criteria

Inclusion Criteria

1. 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.

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

3. Aged 18 to 55 years, inclusive, at the screening visit.

4. 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.

5. Must be American Society of Anesthesiologists (ASA) Classification I with a Mallampati score less than (<) III, and judged to be in good health based on results of safety laboratory tests (biochemistry, hematology, and urinalysis testing) performed at the screening visit and on medical history, physical examination, vital-sign measurements, and 12-lead electrocardiogram (ECG) performed at screening and Study Day 1 visits.

6. Not expected to have difficulty with the use of an laryngeal mask airway (LMA) as determined by the anesthesiologist or site staff.

Exclusion Criteria

1. Received immunotherapy within the past year.

2. Has a history or family history of malignant hyperthermia or are known or suspected to have an allergy to inhalational anesthetics, propofol, neuromuscular blocking agents and/or other drugs used during general anesthesia.

3. Has facial hair that could interfere with the seal of a facemask per investigator or site staff and is unwilling to shave it off before check-in.

4. Has undergone major surgery or donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the screening visit.

5. Has a risk of suicide according to endorsement of Item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening/baseline visit or have made a suicide attempt in the previous 6 months.

6. Has a positive alcohol or drug screen at screening or Day 1 or has a history of alcohol consumption exceeding 2 standard drinks per day on average within the 12 months before screening. Participants who test positive for cannabis will be excluded.

7. Has caffeine consumption of more than 400 milligram per day (mg/day) for 2 weeks before screening (1 serving of coffee is approximately equivalent to 120 milligram [mg] of caffeine).

8. Has a screening ECG with a QT interval with Fridericia correction method (QTcF) greater than (>) 450 millisecond (ms) (men) or >470 ms (women).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Endeavor Clinical Trials

San Antonio, Texas, United States

Countries

United States

Related Links

https://clinicaltrials.takeda.com/study-detail/61421bb6c15195002c0ba2d8

To obtain more information on the study, click here/on this link

Other Identifiers

TAK-925-1019

Identifier Type: -

Identifier Source: org_study_id