Pharmacokinetic Study of Single and Repeated Dose of Rofl... | NCT01354782

NCT01354782

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Roflumilast	Experimental	(This is a pharmacokinetic study)	Drug: Roflumilast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

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