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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Roflumilast

Study type

Interventional

Funder types

Industry

Identifiers

NCT01354782

RO-2455-101-EC

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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