Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Open-label, Single Dose, Parallel Arm, Active Comparator Clinical Phase I Study
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 193
- Locations
- 2
- Primary Endpoint
- Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Overview
Brief Summary
This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
adalimumab - US
Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab
Intervention: adalimumab (Drug)
BI 695501
Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501
Intervention: BI695501 (Drug)
adalimumab - EU
Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab
Intervention: adalimumab (Drug)
Outcomes
Primary Outcomes
Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)(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)