Pharmacokinetics and Safety in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: adalimumab-US source; Drug: BI 695501; Drug: adalimumab-EU source

• Registration Number: NCT02045979
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Study Start: 2014-01-31
• Primary Completion: 2014-06-20
• Study Completion: 2014-06-20
• Status Verified: 2017-09
• Results First Submitted: 2017-09-11
• Results First Submitted QC: 2017-09-11
• Last Update Submitted: 2017-09-11
• Results First Posted: 2018-06-20
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 327

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®	at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.	Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®.; Abbreviation used: Pharmacokinetics (PK).
Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®	at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.	Area under the concentration time curve from time zero to last measurable concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.
Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®	at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.	Maximum concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®.

Secondary Outcome Measures

Name	Time	Method
AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®	at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168 hours post dosing	Area under the concentration time curve (AUC) from time zero to 168 hours post dose (AUC 0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®.; PK is the abbreviation for Pharmacokinetic(s).
AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®	at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312 hours post dosing	Area under the concentration time curve (AUC) from time zero to 312 hours post dose (AUC 0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®.; PK is the abbreviation for Pharmacokinetic(s).
AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®	at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480 hours post dosing	Area under the concentration time curve (AUC) from time zero to 480 hours post dose (AUC 0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®.; PK is the abbreviation for Pharmacokinetic(s).
AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®	at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648 hours post dosing	Area under the concentration time curve (AUC) from time zero to 648 hours post dose (AUC 0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®.; PK is the abbreviation for Pharmacokinetic(s).
AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira®	at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032 hours post dosing	Area under the concentration time curve (AUC) from time zero to 1032 hours post dose (AUC 0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® PK is the abbreviation for Pharmacokinetic(s).
AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira®	at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.	Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) based on the last observed concentration at time of last measureable concentration (tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.; PK is the abbreviation of Pharmacokinetic(s).
Number (Proportion) of Subjects With Drug Related Adverse Events	Day 1 through Day 71	All events with an onset after the first administration of the trial medication up to a period of 70 days after the last administration of the trial medication (i.e., end of the REP) was assigned to the treatment phase for evaluation and was defined as a treatment-emergent AE (TEAE). A treatment-related AE was defined as any TEAE assessed by the investigator as related to the trial medication.; All safety data were displayed and analyzed using descriptive statistical methods. No formal inferential analyses were planned for safety comparisons. Tabulations of frequencies and proportions, as appropriate were used for the evaluation of categorical (qualitative) data, and tabulations of descriptive statistics were used to analyze continuous (quantitative) data.

Trial Locations

Locations (3)

1297.8.1001 Boehringer Ingelheim Investigational Site; 🇧🇪 Antwerpen, Belgium

1297.8.2002 Boehringer Ingelheim Investigational Site; 🇳🇿 Christchurch, New Zealand

1297.8.2001 Boehringer Ingelheim Investigational Site; 🇳🇿 Auckland, New Zealand