Pharmacokinetics and Safety in Healthy Volunteers

NCT02045979 | Completed Phase 1 Results

• 2 other identifiers: 1297.82013-003722-84
• Study Type: interventional
• Target: 327
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®

  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).

  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®

  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.

• Maximum Concentration (Cmax) 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.

Secondary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

BI 695501

EXPERIMENTAL

Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501

Drug: BI 695501

adalimumab-EU source

ACTIVE COMPARATOR

Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source

Drug: adalimumab-EU source

adalimumab-US source

ACTIVE COMPARATOR

Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-US source

Drug: adalimumab-US source

Interventions

BI 695501 DRUG

BI 695501 single s.c. injection

BI 695501

adalimumab-EU source DRUG

adalimumab-EU source single s.c. injection

adalimumab-EU source

adalimumab-US source DRUG

adalimumab-US source single s.c. injection.

adalimumab-US source

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (blood pressure \[BP\] and pulse rate \[PR\]), 12-lead electrocardiogram (ECG), and clinical laboratory tests;
• Age-greater than or equal to 18 years and less than or equal to 55 years;
• Body mass index (BMI) =18.5 to =29.9 kg/m2; and
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.

You may not qualify if:

• Any clinically relevant abnormal finding of the medical examination (including blood pressure (BP), pulse rate (PR), and electrocardiogram (ECG) deviating from normal and of clinical relevance;
• Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders, or diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders;
• History of relevant orthostatic hypotension, fainting spells, or blackouts;
• Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation;
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients);
• Intake of prescribed or over-the-counter drugs with a long half-life (greater than 24 hours) within at least one month or at least 5 half-lives of the respective drug (whichever is longer) prior to administration or during the trial;
• Previous exposure of a biologic drug;
• Use of drugs which might reasonably influence the results of the trial prior to dosing and at any time during the trial;
• Intake of an investigational drug in another trial within two months prior to intake of study medication in this trial or intake of an investigational drug during the course of this trial;
• Smoker (greater than 10 cigarettes or greater than 3 cigars or greater than 3 pipes/day);
• Inability to refrain from smoking during days of confinement at the trial site;
• History of alcohol abuse (estimated average more than 4 units/day);
• Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the study medication administration and until Day 7 post study medication administration;
• Unwillingness/inability to limit alcohol intake to a maximum of three units per day until e.o.s.;
• Current drug abuse;

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (3)

1297.8.1001 Boehringer Ingelheim Investigational Site

Antwerp, Belgium

Location

1297.8.2001 Boehringer Ingelheim Investigational Site

Auckland, New Zealand

Location

1297.8.2002 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

Related Publications (3)

• Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.

  PMID: 33263165 DERIVED

• Kang J, Eudy-Byrne RJ, Mondick J, Knebel W, Jayadeva G, Liesenfeld KH. Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity. Br J Clin Pharmacol. 2020 Nov;86(11):2274-2285. doi: 10.1111/bcp.14330. Epub 2020 Jun 11.

  PMID: 32363771 DERIVED

• Wynne C, Altendorfer M, Sonderegger I, Gheyle L, Ellis-Pegler R, Buschke S, Lang B, Assudani D, Athalye S, Czeloth N. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE(R)-PK) in healthy subjects. Expert Opin Investig Drugs. 2016 Dec;25(12):1361-1370. doi: 10.1080/13543784.2016.1255724.

  PMID: 27813422 DERIVED

MeSH Terms

Interventions

BI 695501

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: January 31, 2014
• Primary Completion: June 20, 2014
• Study Completion: June 20, 2014
• Last Updated: June 20, 2018
• Results First Posted: June 20, 2018

Record last verified: 2017-09

Locations

NZ (2); BE (1)