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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014