Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Open-label, Single Dose, Parallel Arm, Active Comparator Clinical Phase I Study

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI695501; Drug: adalimumab

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • 1297.1.002 Boehringer Ingelheim Investigational Site
  • Christchurch, New Zealand
    • 1297.1.001 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 695501; Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501	Drug: BI695501; BI 695501 single s.c injection
Active Comparator: adalimumab - US; Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab	Drug: adalimumab; 40mg adalimumab single s.c. injection
Active Comparator: adalimumab - EU; Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab	Drug: adalimumab; 40mg adalimumab single s.c. injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). 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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 4, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: 1297.1