CompletedPhase 2

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease

United States33 participantsStarted 2025-10-06

Plain-language summary

This study will assess the pharmacokinetics (PK), pharmacodynamics (PD) and safety of ensifentrine and glycopyrrolate fixed dose (FDC) product, the individual components of the FDC (ensifentrine and glycopyrrolate, each in the FDC formulation), ensifentrine 1.5 mg in the FDC formulation and ensifentrine 3 mg in the marketed formulation each administered via a standard jet nebulizer, in adult participants with chronic obstructive pulmonary disease (COPD).

Who can participate

Age range40 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Not a woman of child-bearing potential OR
✓. Agrees to follow the contraceptive guidance and not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study
✓. FEV1/forced vital capacity (FVC) ratio of \< 0.70 AND
✓. FEV1 ≥ 40 % and ≤ 80% of predicted normal

Exclusion criteria

✕. Unstable cardiac disease (myocardial infarction within 1 year prior to randomization, unstable angina within 6 months prior to randomization, unstable or life-threatening arrhythmia requiring intervention within 3 months prior to randomization, diagnosis of New York Heart Association (NYHA) class III or IV heart disease)
✕. Any other clinically significant medical conditions including uncontrolled diseases (e.g., endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric \[e.g., untreated significant depression, anxiety, or history of suicidality\], or ophthalmic diseases) that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject

What they're measuring

Ensifentrine single dose area under the curve from time 0 to time t (AUC0-t)

Timeframe: Day 1 through 48 hours after each dose of study medication

Ensifentrine single dose area under the curve from time 0 extrapolated to infinity (AUC0-inf)

Timeframe: Day 1 through 48 hours after each dose of study medication

Ensifentrine single dose maximum observed concentration (Cmax)

Timeframe: Day 1 through 48 hours after each dose of study medication

Glycopyrronium single dose AUC0-t

Timeframe: Day 1 through 48 hours after each dose of study medication

Glycopyrronium single dose AUC0-inf

Timeframe: Day 1 through 48 hours after each dose of study medication

Glycopyrronium single dose Cmax

Timeframe: Day 1 through 48 hours after each dose of study medication

Change from average baseline in forced expiratory volume over 1 second (FEV1) to FEV1 area under the curve versus time from time 0 to 12 hours (AUC0-12h)

Timeframe: Baseline through 12 hours after each dose of study medication

Trial details

NCT IDNCT07132983

SponsorVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials

Plain-language summary

Who can participate

Age range40 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Not a woman of child-bearing potential OR
✓. Agrees to follow the contraceptive guidance and not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study
✓. FEV1/forced vital capacity (FVC) ratio of \< 0.70 AND
✓. FEV1 ≥ 40 % and ≤ 80% of predicted normal

Exclusion criteria

✕. Unstable cardiac disease (myocardial infarction within 1 year prior to randomization, unstable angina within 6 months prior to randomization, unstable or life-threatening arrhythmia requiring intervention within 3 months prior to randomization, diagnosis of New York Heart Association (NYHA) class III or IV heart disease)
✕. Any other clinically significant medical conditions including uncontrolled diseases (e.g., endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric \[e.g., untreated significant depression, anxiety, or history of suicidality\], or ophthalmic diseases) that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject

What they're measuring

Ensifentrine single dose area under the curve from time 0 to time t (AUC0-t)

Timeframe: Day 1 through 48 hours after each dose of study medication

Ensifentrine single dose area under the curve from time 0 extrapolated to infinity (AUC0-inf)

Timeframe: Day 1 through 48 hours after each dose of study medication

Ensifentrine single dose maximum observed concentration (Cmax)

Timeframe: Day 1 through 48 hours after each dose of study medication

Glycopyrronium single dose AUC0-t

Timeframe: Day 1 through 48 hours after each dose of study medication

Glycopyrronium single dose AUC0-inf

Timeframe: Day 1 through 48 hours after each dose of study medication

Glycopyrronium single dose Cmax

Timeframe: Day 1 through 48 hours after each dose of study medication

Change from average baseline in forced expiratory volume over 1 second (FEV1) to FEV1 area under the curve versus time from time 0 to 12 hours (AUC0-12h)

Timeframe: Baseline through 12 hours after each dose of study medication