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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedStudy Start
First participant enrolled
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2022
CompletedMay 10, 2022
May 1, 2022
5 months
August 26, 2021
May 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE)
Up to Day 7
Secondary Outcomes (3)
Ceoi: Observed Plasma Concentration at the end of Infusion for Danavorexton
Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Danavorexton
Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Danavorexton
Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
Study Arms (4)
Cohort A1: Danavorexton Low Dose
EXPERIMENTALDanavorexton 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.
Cohort A2: Danavorexton Middle Dose
EXPERIMENTALDanavorexton 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.
Cohort A3: Danavorexton High Dose
EXPERIMENTALDanavorexton 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.
Cohort P: Danavorexton TBD
EXPERIMENTALDanavorexton 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.
Interventions
Danavorexton intravenous infusion.
Danavorexton placebo-matching intravenous infusion.
Propofol intravenous bolus.
Sevoflurane inhalation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Endeavor Clinical Trials
San Antonio, Texas, 78229-3818, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2021
First Posted
August 27, 2021
Study Start
September 28, 2021
Primary Completion
March 8, 2022
Study Completion
March 8, 2022
Last Updated
May 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.