Back to resultsPharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Pharmacokinetic, Roflumilast
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
Sites / Locations
- Nycomed Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Roflumilast
Arm Description
(This is a pharmacokinetic study)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01354782
Brief Title
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Pharmacokinetic, Roflumilast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Roflumilast
Arm Type
Experimental
Arm Description
(This is a pharmacokinetic study)
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the pharmacokinetic profiles after single and repeated dose of roflumilast 500 µg administered to healthy Chinese subjects.
Description
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
Time Frame
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 Measure Information:
Title
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.
Time Frame
During screening, clinical part and final check
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Nycomed Investigational Site
City
Beijing
ZIP/Postal Code
100032
Country
China
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4497&filename=RO-2455-101-EC-RDS-2012-04-26.pdf
Description
RO-2455-101-EC-RDS-2012-04-26.pdf
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Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects
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