Pharmacokinetic Study of single and repeated dose of roflumilast 500 µg , in healthy Chinese subjects

Study identifier:RO-2455-101-EC

ClinicalTrials.gov identifier:NCT01354782

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 1

Healthy volunteers

Study drug

Roflumilast

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 May 2011

Primary Completion Date: 01 Jun 2011

Study Completion Date: 01 Sept 2011

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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

No locations available

Arms	Assigned Interventions
Experimental: Roflumilast (This is a pharmacokinetic study)	Drug: Roflumilast 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.

Documents available

RO-2455-101-EC-RDS-2012-04-26.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

AstraZeneca AstraZeneca

AstraZeneca