Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505491
• Other study ID #: 1297.1
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2011
• Est. completion date: July 1, 2012

Study information

• Verified date: October 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: July 1, 2012
• Est. primary completion date: July 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• adalimumab
40mg adalimumab single s.c. injection
• BI695501
BI 695501 single s.c injection
• adalimumab
40mg adalimumab single s.c. injection

Locations

Country	Name	City	State
New Zealand	1297.1.002 Boehringer Ingelheim Investigational Site	Auckland
New Zealand	1297.1.001 Boehringer Ingelheim Investigational Site	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-8)	Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.	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
Primary	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)	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). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.	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
Primary	Maximum Measured Concentration of the BI 695501 in Plasma (Cmax)	Maximum measured concentration of the BI 695501 in plasma (Cmax). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.	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	Terminal Half- Life of the BI 695501 in Plasma (t1/2)	Terminal half- life of the BI 695501 in plasma (t1/2).	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	Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F)	Apparent clearance of the BI 695501 in the plasma after extra-vascular administration (CL/F).	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

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