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A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea

Primary Purpose

Sleep Apnea

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Danavorexton

Placebo

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring Drug Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has OSA diagnosed according to the International Classification of Sleep Disorders-3 (ICSD-3) criteria and an AHI of 12-50 events/hour sleep (documented by an in-clinic PSG or at-home sleep test within the last 12 months). Participants who do not have PSG results from within 12 months available may be offered a screening home sleep test.
Those who use continuous positive airway pressure (CPAP), oral appliance, or hypoglossal nerve stimulator must be willing to forego this therapy during all in-clinic PSGs and during the home sleep test if one is required.
Has no known history of a sleep disorder other than OSA based on interviews at the screening visit, such as, for example, restless legs syndrome accompanied by periodic leg movements of sleep.
Has a regular bedtime (example, between 8 p.m. - 1 a.m.) and regular time in bed averaging between 6.0 and 10.0 hours/night, as verified by sleep tracking mat and sleep diary data. Sleep durations and bedtimes outside of this range can be discussed for inclusion on a case by case basis with the sponsor.
Has a body mass index (BMI) of 18 to 38.5 kilogram per square meter (kg/m^2) inclusive.

Exclusion Criteria:

Has an occupation requiring nighttime shift work or variable shift work within the past 2 months or has travelled with significant jet lag within 14 days before the study start or plans to travel with significant jet lag during the study.
Has nicotine dependence that is likely to have an effect on sleep (example, a participant who routinely awakens at night to smoke) or challenge the conduct of this study (smokes >=10 cigarettes/day), or the participant is unwilling to discontinue all smoking and nicotine use during the confinement periods.
Has a caffeine consumption of more than 600 milligram (mg)/day for 7 days before Period 1 Day 1 (1 serving of coffee is approximately equivalent to 120 mg of caffeine; 16 ounces of cola or energy drink contain approximately 39 and 148 mg of caffeine, respectively).

Sites / Locations

Adelaide Institute for Sleep Health (AISH), Flinders University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Danavorexton LD

Danavorexton HD

Arm Description

Placebo infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.

Danavorexton LD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.

Danavorexton HD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Upper Airway Collapsibility Index (UACI)

The UACI is a 10-minute evaluation that tests the key biological mechanism that causes obstructive sleep apnea (OSA).

Apnea-Hypopnea Index (AHI) Observed During Overnight Polysomnographys (PSGs)

PSG analysis will be performed to determine an apnea hypopnea index. AHI score is used to indicate the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. An apnea hypopnea index less than five events per hour is considered within normal limits.

Full Information

NCT ID

NCT05180890

First Posted

January 3, 2022

Last Updated

December 1, 2022

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT05180890

Brief Title

A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea

Official Title

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Safety, Tolerability, Pharmacodynamic, and Pharmacokinetic Effects of Overnight Intravenous TAK-925 in Patients With Obstructive Sleep Apnea

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

March 10, 2022 (Actual)

Primary Completion Date

November 23, 2022 (Actual)

Study Completion Date

November 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The main aim of the study is to check the side effects from overnight treatment with danavorexton and assess the tolerability of varying doses of danavorexton administered intravenously. Before starting treatment with danavorexton, participants will keep a sleep diary and use an under-mattress sensor for at least 7 nights to check regular sleep habits. There will be 3 Treatment Period up to 14 days apart. In each Treatment Period, participants will receive an intravenous (through the vein) infusion of either danavorexton or a placebo starting in the evening and continuing over a 10-hour period. A placebo looks exactly like danavorexton but does not have any medicine in it. Participants will take part in a follow-up phone appointment about a week after the last Treatment Period.

Detailed Description

The drug being tested in this study is called danavorexton. The study will look at the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD) effects of danavorexton. The study will enroll approximately 18 participants (to acquire data in 'n' greater than or equal to [>=] 12). Each participant will receive one of the following treatments in each Treatment Period: Danavorexton low dose (LD), danavorexton high dose (HD), or placebo. All participants will receive all 3 treatments. A washout period of a minimum of 2 days up to 14 days will be maintained between the end of infusion to the start time of next infusion. The order in which each participant receives the 3 treatments will be randomly assigned. Treatment order will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need). This single-center trial will be conducted in Australia. The overall time to participate in this study is up to 69 days. Participants will be followed remotely until 5 to 9 days after the last dose of study drug in the Treatment Period 3.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

Keywords

Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.

Arm Title

Danavorexton LD

Arm Type

Experimental

Arm Description

Danavorexton LD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.

Arm Title

Danavorexton HD

Arm Type

Experimental

Arm Description

Danavorexton HD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.

Intervention Type

Drug

Intervention Name(s)

Danavorexton

Other Intervention Name(s)

TAK-925

Intervention Description

Danavorexton intravenous infusion.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo intravenous infusion.

Primary Outcome Measure Information:

Title

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

Time Frame

From the first dose of danavorexton in Treatment Period 1 up to approximately 7 days after the last dose of danavorexton in Treatment Period 3 (up to 41 days)

Secondary Outcome Measure Information:

Title

Change From Baseline in Upper Airway Collapsibility Index (UACI)

Description

The UACI is a 10-minute evaluation that tests the key biological mechanism that causes obstructive sleep apnea (OSA).

Time Frame

Baseline (-15 minutes from the start of infusion [first UACI]), and at 20 minutes (second UACI), and 55 minutes (third UACI) on Day 1 of each Treatment Period

Title

Apnea-Hypopnea Index (AHI) Observed During Overnight Polysomnographys (PSGs)

Description

Time Frame

Day 1 up to Day 2 of each Treatment Period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has OSA diagnosed according to the International Classification of Sleep Disorders-3 (ICSD-3) criteria and an AHI of 12-50 events/hour sleep (documented by an in-clinic PSG or at-home sleep test within the last 12 months). Participants who do not have PSG results from within 12 months available may be offered a screening home sleep test. Those who use continuous positive airway pressure (CPAP), oral appliance, or hypoglossal nerve stimulator must be willing to forego this therapy during all in-clinic PSGs and during the home sleep test if one is required. Has no known history of a sleep disorder other than OSA based on interviews at the screening visit, such as, for example, restless legs syndrome accompanied by periodic leg movements of sleep. Has a regular bedtime (example, between 8 p.m. - 1 a.m.) and regular time in bed averaging between 6.0 and 10.0 hours/night, as verified by sleep tracking mat and sleep diary data. Sleep durations and bedtimes outside of this range can be discussed for inclusion on a case by case basis with the sponsor. Has a body mass index (BMI) of 18 to 38.5 kilogram per square meter (kg/m^2) inclusive. Exclusion Criteria: Has an occupation requiring nighttime shift work or variable shift work within the past 2 months or has travelled with significant jet lag within 14 days before the study start or plans to travel with significant jet lag during the study. Has nicotine dependence that is likely to have an effect on sleep (example, a participant who routinely awakens at night to smoke) or challenge the conduct of this study (smokes >=10 cigarettes/day), or the participant is unwilling to discontinue all smoking and nicotine use during the confinement periods. Has a caffeine consumption of more than 600 milligram (mg)/day for 7 days before Period 1 Day 1 (1 serving of coffee is approximately equivalent to 120 mg of caffeine; 16 ounces of cola or energy drink contain approximately 39 and 148 mg of caffeine, respectively).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Adelaide Institute for Sleep Health (AISH), Flinders University

City

Adelaide

ZIP/Postal Code

5042

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing 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.

IPD Sharing URL

https://vivli.org/ourmember/takeda/

Links:

URL

https://clinicaltrials.takeda.com/study-detail/5af25efdcb954c82?idFilter=%5B%22TAK-925-1020%22%5D

Description

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A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea

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