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

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ClinicalTrials.gov Identifier: NCT03646864
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: ACT-541468 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2-way crossover study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Moderate Chronic Obstructive Pulmonary Disease
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Treatment A
ACT-541468 50 mg from Day 1 to Day 5 of Period A
Drug: 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.

Placebo Comparator: Treatment B
Placebo from Day 1 to Day 5 of Period B
Other: Placebo
Placebo will be orally administered as a tablet matching ACT-541468, o.d. in the evening.




Primary Outcome Measures :
  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 [ Time Frame: Duration: for up to 8 hours ]

Other Outcome Measures:
  1. Mean SaO2 during TST after single-dose administration (i.e., at Night 1) as measured by finger pulse oximetry and PSG [ Time Frame: Duration: for up to 8 hours ]
  2. 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 [ Time Frame: Duration: for up to 8 hours ]
  3. Mean SaO2 during each sleep phase (awake, non REM, REM) following single- and multiple-dose administration as measured by finger pulse oximetry and PSG [ Time Frame: Duration: for up to 8 hours ]
  4. Mean AHI following single- and multiple-dose administration, as measured by PSG. [ Time Frame: Duration: for up to 8 hours ]
    AHI is defined as total number of apnea (pause in respiration for more than 10 sec) and hypopnea (reduction of breathing ≥ 50% during at least 10 sec) events divided by TST (in min) multiplied by 60.

  5. Safety profile including incidence of adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Duration: for up to 10 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646864


Contacts
Contact: Clinical Trial Disclosure Desk +41 58 844 0000 clinical-trials-disclosure@idorsia.com

Locations
Germany
Advanced Sleep Research Recruiting
Berlin, Germany, 10117
framol-med GmbH, Lungenpraxis Not yet recruiting
Rheinau, Germany, 48431
ZMS Recruiting
Warendorf, Germany, 48231
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.

Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03646864     History of Changes
Other Study ID Numbers: ID-078-109
2018-001828-19 ( EudraCT Number )
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases