Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI695501; Drug: adalimumab

• Registration Number: NCT01505491
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-06
• Primary Completion: 2012-07-01
• Study Completion: 2012-07-01
• Status Verified: 2018-10
• Results First Submitted: 2018-10-04
• Results First Submitted QC: 2018-10-04
• Last Update Submitted: 2018-10-04
• Results First Posted: 2019-02-20
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 193

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 695501	BI695501	Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501
adalimumab - US	adalimumab	Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab
adalimumab - EU	adalimumab	Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	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 extrapolated to infinity (AUC0-∞). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.
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)	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). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.
Maximum Measured Concentration of the BI 695501 in Plasma (Cmax)	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). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.

Secondary Outcome Measures

Name	Time	Method
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	Terminal half- life of the BI 695501 in plasma (t1/2).
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	Apparent clearance of the BI 695501 in the plasma after extra-vascular administration (CL/F).

Trial Locations

Locations (2)

1297.1.002 Boehringer Ingelheim Investigational Site; 🇳🇿 Auckland, New Zealand

1297.1.001 Boehringer Ingelheim Investigational Site; 🇳🇿 Christchurch, New Zealand