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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nycomed
ClinicalTrials.gov Identifier:
NCT01354782
First received: May 16, 2011
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Roflumilast
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • To determine the pharmacokinetic profiles after single and repeated dose of roflumilast 500 µg administered to healthy Chinese subjects. [ 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: During screening, clinical part and final check ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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.


  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354782

Locations
China
Nycomed Investigational Site
Beijing, China, 100032
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Clinical Trial Operations Headquarters
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT01354782     History of Changes
Other Study ID Numbers: RO-2455-101-EC
Study First Received: May 16, 2011
Last Updated: May 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Nycomed:
Pharmacokinetic
Roflumilast

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014