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

NCT05180890 | Completed Phase 1

• 1 other identifier: TAK-925-1020
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Change From Baseline in Upper Airway Collapsibility Index (UACI)

  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

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

  Day 1 up to Day 2 of each Treatment Period

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Danavorexton LD

EXPERIMENTAL

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

Drug: Danavorexton

Danavorexton HD

EXPERIMENTAL

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

Drug: Danavorexton

Interventions

Danavorexton DRUG

Danavorexton intravenous infusion.

Also known as: TAK-925

Danavorexton HD; Danavorexton LD

Placebo DRUG

Placebo intravenous infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 body mass index (BMI) of 18 to 38.5 kilogram per square meter (kg/m\^2) inclusive.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Adelaide Institute for Sleep Health (AISH), Flinders University

Adelaide, 5042, Australia

Location

Related Links

• To obtain more information on the study, click on this link

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

TAK-925

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 6, 2022
• Study Start: March 10, 2022
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

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.

Locations

AU (1)