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Healthy VolunteersPhase 1NCT05025397

A Study of Danavorexton in Anesthetized Adults

A Phase 1 study testing Danavorexton, Propofol and Sevoflurane in people with Healthy Volunteers, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Danavorexton, Propofol and Sevoflurane
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteUnited States
Study dates
28 Sep 2021to 8 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 regular sleep-wake habits (example, routinely spends 6.5 to 9 hours in bed nightly).
  • Aged 18 to 55 years, inclusive, at the screening visit.
  • 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.
  • 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.
  • Not expected to have difficulty with the use of an laryngeal mask airway (LMA) as determined by the anesthesiologist or site staff.

Who cannot join

  • Received immunotherapy within the past year.
  • 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.
  • 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.
  • Has undergone major surgery or donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the screening visit.
  • 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.
  • 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.
  • 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).
  • Has a screening ECG with a QT interval with Fridericia correction method (QTcF) greater than (>) 450 millisecond (ms) (men) or >470 ms (women).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Endeavor Clinical Trials

    San Antonio, Texas, 78229-3818

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Danavorexton, Danavorexton Placebo, Propofol, Sevoflurane
Keywords
Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DanavorextonDrug

    Also called TAK-925

    Danavorexton intravenous infusion.

  • Danavorexton PlaceboDrug

    Danavorexton placebo-matching intravenous infusion.

  • PropofolDrug

    Propofol intravenous bolus.

  • SevofluraneDrug

    Sevoflurane inhalation.

  • PropofolDrug

    Propofol intravenous infusion.

Study groups in NCT05025397
Study groupRoleWhat they receive
Cohort A1: Danavorexton Low DoseExperimentalDanavorexton 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.
Receives: Drug: Danavorexton; Drug: Danavorexton Placebo; Drug: Propofol; Drug: Sevoflurane
Cohort A2: Danavorexton Middle DoseExperimentalDanavorexton 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.
Receives: Drug: Danavorexton; Drug: Danavorexton Placebo; Drug: Propofol; Drug: Sevoflurane
Cohort A3: Danavorexton High DoseExperimentalDanavorexton 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.
Receives: Drug: Danavorexton; Drug: Danavorexton Placebo; Drug: Propofol; Drug: Sevoflurane
Cohort P: Danavorexton TBDExperimentalDanavorexton 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.
Receives: Drug: Danavorexton; Drug: Danavorexton Placebo; Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE)

    Measured: Up to Day 7

Secondary outcomes (3)

  1. Ceoi: Observed Plasma Concentration at the end of Infusion for Danavorexton

    Measured: Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion

  2. AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Danavorexton

    Measured: Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion

  3. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Danavorexton

    Measured: Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start28 Sep 2021
  3. Primary completion8 Mar 2022
  4. Study completion8 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05025397
Sponsor's protocol ID
TAK-925-1019
Status last verified
May 2022
First submitted
26 Aug 2021
Last updated
10 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Suzuki M, Shiraishi E, Cronican J, Kimura H. Effects of the orexin receptor 2 agonist danavorexton on emergence from general anaesthesia and opioid-induced sedation, respiratory depression, and analgesia in rats and monkeys. Br J Anaesth. 2024 Mar;132(3):541-552. doi: 10.1016/j.bja.2023.12.032. Epub 2024 Feb 1.

    PubMed 38296753

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Danavorexton, Propofol and Sevoflurane in people with Healthy Volunteers, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE) (time frame: Up to Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05025397, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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