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

NCT ID: NCT03646864

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-15
• Study Completion Date: 2019-09-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment A

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

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: 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 B

Placebo from Day 1 to Day 5 of Period B

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

ACT-541468

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

Advanced Sleep Research

Berlin, , Germany

Klinische Forschungsgruppe Nord

Dresden, , Germany

Klinische Forschungsgruppe Nord

Hanover, , Germany

framol-med GmbH, Lungenpraxis

Rheinau, , Germany

ZMS

Warendorf, , Germany

Countries

Germany

Other Identifiers

2018-001828-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ID-078-109

Identifier Type: -

Identifier Source: org_study_id