Clinical trial NCT01354782: Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pharmacokinetic
Roflumilast
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-17
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: To determine the pharmacokinetic profiles after single and repeated dose of roflumilast 500 µg administered to healthy Chinese subjects.
timeFrame: Period I: single dose, PK-Investigation over 8 days, Period II: repeated dose for 14 days, PK-Investigation on days 14 and 15
Secondary outcomes:
measure: 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.
timeFrame: During screening, clinical part and final check
Other outcomes:
Locations:
city: Beijing
country: China
facility: Nycomed Investigational Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: