Status:
COMPLETED
Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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
- Inclusion criteria:
- Healthy males
- Body mass index (BMI) =18.5 to =29.9 kg/m2
- Exclusion criteria:
- Any clinically relevant abnormal finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator.
- Chronic or relevant acute infections. A negative result for Human Immunodeficiency Virus, Hepatitis B and Hepatitis C testing is required for participation.
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- 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
- Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
- Inability to refrain from smoking during days of confinement at the study center
- Alcohol abuse (average more than 30 g/day)
- Current drug abuse
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT01505491
Start Date
December 1 2011
End Date
July 1 2012
Last Update
February 20 2019
Active Locations (2)
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1
1297.1.002 Boehringer Ingelheim Investigational Site
Auckland, New Zealand
2
1297.1.001 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand