A Study of Danavorexton in Anesthetized Adults

• Status: Recruiting
• Trial end date: 2022-02-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda
• Treatments: Propofol; Sevoflurane

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).