Clinical trial NCT01505491: Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects
Official title: Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Open-label, Single Dose, Parallel Arm, Active Comparator Clinical Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-01-06
Enrollment: 193
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.


Eligibility criteria: Inclusion criteria:

1. Healthy males
2. Body mass index (BMI) =18.5 to =29.9 kg/m2

Exclusion criteria:

1. Any clinically relevant abnormal finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator.
3. Chronic or relevant acute infections. A negative result for Human Immunodeficiency Virus, Hepatitis B and Hepatitis C testing is required for participation.
4. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
5. Intake of prescribed or over-the-counter drugs with a long half-life (\>24 hours) within at least one month or less than 5 half-lives of the respective drug prior to administration or during the trial
6. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
7. Inability to refrain from smoking during days of confinement at the study center
8. Alcohol abuse (average more than 30 g/day)
9. Current drug abuse

Primary outcomes:
measure: Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
timeFrame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration
measure: Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)
timeFrame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration
measure: Maximum Measured Concentration of the BI 695501 in Plasma (Cmax)
timeFrame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration
Secondary outcomes:
measure: Terminal Half- Life of the BI 695501 in Plasma (t1/2)
timeFrame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration
measure: Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F)
timeFrame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: 1297.1.002 Boehringer Ingelheim Investigational Site
city: Christchurch
country: New Zealand
facility: 1297.1.001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: