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

NCT01354782 | Completed Phase 1

• 1 other identifier: RO-2455-101-EC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pharmacokinetic; Roflumilast

Outcome Measures

Primary Outcomes (1)

• 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

  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 (1)

• 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.

  During screening, clinical part and final check

Study Arms (1)

Roflumilast

EXPERIMENTAL

(This is a pharmacokinetic study)

Drug: Roflumilast

Interventions

Roflumilast DRUG

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.

Roflumilast

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Nycomed Investigational Site

Beijing, 100032, China

Location

Related Links

• RO-2455-101-EC-RDS-2012-04-26.pdf

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 17, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 26, 2016

Record last verified: 2016-09

Locations

CN (1)