A Study to Evaluate the Effects of ACT-541468 on Respiration in Patients With Moderate Chronic Obstructive Pulmonary Disease

NCT03646864 | Completed Phase 1 FDA Drug

• 2 other identifiers: ID-078-1092018-001828-19
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

Brief Summary

A study to evaluate the effects of ACT-541468 on respiration in patients with moderate chronic obstructive pulmonary disease

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Mean SaO2 during total sleep time (TST) after multiple-dose administration (i.e., at Night 5) as measured by finger pulse oximetry and PSG

  Duration: for up to 8 hours

Other Outcomes (5)

• Mean SaO2 during TST after single-dose administration (i.e., at Night 1) as measured by finger pulse oximetry and PSG

  Duration: for up to 8 hours

• Percentage of TST during which SaO2 is < 90%, < 85%, and < 80% following single- and multiple-dose administration as measured by finger pulse oximetry and PSG

  Duration: for up to 8 hours

• Mean SaO2 during each sleep phase (awake, non REM, REM) following single- and multiple-dose administration as measured by finger pulse oximetry and PSG

  Duration: for up to 8 hours

Study Arms (2)

Treatment A

EXPERIMENTAL

ACT-541468 50 mg from Day 1 to Day 5 of Period A

Drug: ACT-541468

Treatment B

PLACEBO COMPARATOR

Placebo from Day 1 to Day 5 of Period B

Other: Placebo

Interventions

ACT-541468 DRUG

ACT-541468 will be orally administered as a tablet (50 mg strength) at a once daily (o.d.) dose of 50 mg in the evening.

Treatment A

Placebo OTHER

Placebo will be orally administered as a tablet matching ACT-541468, o.d. in the evening.

Treatment B

Eligibility Criteria

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

You may qualify if:

• Signed informed consent prior to any study-mandated procedure
• Male and female subjects aged ≥ 18 years
• Body mass index of 18.0 to 35.0 kg/m2
• Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Screening Visit 2 and on Day 1 pre-dose of the first period. They must consistently and correctly use a reliable method of contraception with a failure rate of \< 1% per year, be sexually inactive, or have a vasectomized partner.
• Women of non-childbearing potential, i.e., postmenopausal
• Diagnosis of moderate COPD documented by medical history (including risk factors and familial history) and confirmed by the assessment of dyspnea using the Modified British Medical Research Council (mMRC) questionnaire, the COPD assessment test (CATTM), and the post bronchodilator pulmonary function tests which should meet the modified Global Initiative for Obstructive Lung Disease (GOLD) criterion for moderate obstruction severity:
• Moderate COPD: Forced expiratory volume in 1 sec (FEV1) / Forced vital capacity (FVC) ratio ≤ 70% and 40% ≤ FEV1 \< 80% of predicted
• Subjects with 0 to 1 (not leading to hospital admission) exacerbation in the last year (i.e., who belong to Group A and B of the GOLD classification)

You may not qualify if:

• Pregnant or lactating women
• History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment
• Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results such as history of non-compliance to medical regimen, psychiatric disease, neurological disorders which may impact sleep, motor performance, or cognition
• Need for continuous oxygen therapy or non invasive ventilation that would interfere with the study evaluation (e.g., required during the night), as per investigator judgement
• Subjects with clinically significant abnormality on the screening night PSG as per investigator judgement, including evidence of Periodic limb movement disorder with arousal index ≥ 15/h, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, parasomnia including nightmare disorder, sleep terror disorder, and/or sleepwalking disorder but excluding any COPD-related abnormalities
• Emergency treatment with antibiotics or systemic corticosteroids or any hospitalization due to COPD within 2 months prior to Screening
• SaO2 \< 90% during wakefulness and/or SaO2 \< 85% for \> 5 consecutive min during the screening night PSG
• AHI \> 10 within the last 3 months prior to Screening, or at the polygraphy (PG) assessed after Screening visit 1 and before Screening visit 2 (if no previous data available only) or on the screening night PSG (only for subjects having AHI\<10 at Screening visit 1 or after PG)

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (5)

Advanced Sleep Research

Berlin, 10117, Germany

Location

Klinische Forschungsgruppe Nord

Dresden, 01069, Germany

Location

Klinische Forschungsgruppe Nord

Hanover, 30159, Germany

Location

framol-med GmbH, Lungenpraxis

Rheinau, 48431, Germany

Location

ZMS

Warendorf, 48231, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

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

Model Details: 2-way crossover study

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: November 15, 2018
• Primary Completion: September 19, 2019
• Study Completion: September 19, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)