Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects

Study Overview
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Brief Summary
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The primary objective is to assess the pharmacokinetics (PK) of roflumilast and its metabolite roflumilast N-oxide after single and repeated oral administrations of roflumilast 500 μg in healthy Chinese subjects.

Official Title
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An Open, Single Centre, Single and Repeated Dose Study to Investigate the Pharmacokinetic Profile of Roflumilast and Roflumilast N-oxide After Administration of 500 μg Dose of Roflumilast in Healthy Chinese Subjects

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Roflumilast


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Healthy male and female (24 male and 8 female) subjects of Chinese ethnic origin, age 40 years and older. Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results. Body weight according to a Body Mass Index (BMI) between 19 and 28 kg/[m²], (both inclusive) and a body weight ≥ 50 kg. Females with childbearing potential who are using medically acceptable and reliable method of contraception for the entire study duration, such as tubal ligation, hysterectomy, intrauterine device without hormones or post-menopausal females, the latter is defined as females who have had no menstrual period for at least 2 years. Main Exclusion Criteria: History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food History of allergic reactions to roflumilast or any inactive ingredients of the trial medication History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease (within the last 2 years) History of malignancy within the past 5 years Electrocardiogram (ECG) abnormalities of clinical relevance (e.g. QTc according to Bazett's formula: QTc > 450 msec (male), QTc > 470 msec (female), PQ ≥ 220 msec) Blood pressure ≥ 140 mm HG systolic or ≥ 90 mm HG diastolic Elevated transaminases > 2 x upper Limit of normal range and or increased of the total bilirubin > 1.5 upper Limit of normal range Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables Chronic or clinically relevant acute infections Proneness to orthostatic dysregulation, faintings, or blackouts Positive results in any of the virology tests of acute or chronic infectious HIV and hepatitis A, B, and C virus infections Positive drug screen Abuse of alcohol or drugs Positive β-HCG pregnancy test (female) Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roflumilast<br>(This is a pharmacokinetic study) | Drug: Roflumilast<br>* Period I: single dose of roflumilast 500 μg orally in the morning. Period II: repeated dose of roflumilast 500 μg orally in the morning for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetic profiles after single and repeated dose of roflumilast 500 µg administered to healthy Chinese subjects. | PK samples at pre-dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h and 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h post dose after single dose and at the time points pre-dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h and 24h after administration of a repeated dose | Period I: single dose, PK-Investigation over 8 days, Period II: repeated dose for 14 days, PK-Investigation on days 14 and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of single and repeated dose roflumilast 500 µg will be evaluated in terms of adverse event, ECG, blood pressure, pulse rate, and clinical laboratory tests. |  | During screening, clinical part and final check | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetic, Roflumilast