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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02045979




Registration number
NCT02045979
Ethics application status
Date submitted
23/01/2014
Date registered
27/01/2014
Date last updated
20/06/2018

Titles & IDs
Public title
Pharmacokinetics and Safety in Healthy Volunteers
Scientific title
Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Double-blind, Single Dose, Parallel-arm, Active Comparator Clinical Phase I Study
Secondary ID [1] 0 0
2013-003722-84
Secondary ID [2] 0 0
1297.8
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 695501
Treatment: Drugs - adalimumab-EU source
Treatment: Drugs - adalimumab-US source

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

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

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


Treatment: Drugs: BI 695501
BI 695501 single s.c. injection

Treatment: Drugs: adalimumab-EU source
adalimumab-EU source single s.c. injection

Treatment: Drugs: adalimumab-US source
adalimumab-US source single s.c. injection.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-8) of BI 695501, US-licensed Humira® or EU-approved Humira® - Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-8) of BI 695501, US-licensed Humira® or EU-approved Humira®.
Abbreviation used: Pharmacokinetics (PK).
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
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®.
Timepoint [2] 0 0
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.
Primary outcome [3] 0 0
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®.
Timepoint [3] 0 0
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 outcome [1] 0 0
AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira® - 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).
Timepoint [1] 0 0
at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168 hours post dosing
Secondary outcome [2] 0 0
AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira® - 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).
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira® - 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).
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira® - 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).
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® - 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).
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
AUC 0-8,Obs of BI 695501, US-licensed Humira® or EU-approved Humira® - Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-8) 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).
Timepoint [6] 0 0
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 outcome [7] 0 0
Number (Proportion) of Subjects With Drug Related Adverse Events - 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.
Timepoint [7] 0 0
Day 1 through Day 71

Eligibility
Key inclusion criteria
Inclusion criteria:

Healthy males according to the following criteria:

1. 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;

2. Age-greater than or equal to 18 years and less than or equal to 55 years;

3. Body mass index (BMI) =18.5 to =29.9 kg/m2; and

4. Signed and dated written informed consent prior to admission to the study in
accordance with Good Clinical Practice and the local legislation.
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

1. 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;

2. 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;

3. History of relevant orthostatic hypotension, fainting spells, or blackouts;

4. 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;

5. History of relevant allergy/hypersensitivity (including allergy to drug or its
excipients);

6. 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;

7. Previous exposure of a biologic drug;

8. Use of drugs which might reasonably influence the results of the trial prior to dosing
and at any time during the trial;

9. 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;

10. Smoker (greater than 10 cigarettes or greater than 3 cigars or greater than 3
pipes/day);

11. Inability to refrain from smoking during days of confinement at the trial site;

12. History of alcohol abuse (estimated average more than 4 units/day);

13. 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;

14. Unwillingness/inability to limit alcohol intake to a maximum of three units per day
until e.o.s.;

15. Current drug abuse;

16. Blood donation (more than 100 mL within four weeks prior to administration of the
study medication or during the trial);

17. Vigorous exercise 72 hours prior to dosing. Unwilling to avoid vigorous exercise for 7
days post dosing. Contact sport should be avoided during the entire study;

18. Any out-of-range laboratory values considered clinically significant by the
investigator; subjects with creatine kinase (CK) values three times the upper limit of
normal (ULN) at Day -1 are excluded from participation;

19. Subjects considered unsuitable for inclusion by the investigator (e.g., inability to
understand and comply with the study requirements or presence of any condition which,
in the opinion of the investigator, would not allow safe participation in the study);
or

20. Inability to comply with dietary regimen of trial site.

21. Subjects with known Human immunodeficiency virus (HIV), Acquired Immunodeficiency
Syndrome, other clinically significant immunological disorders, or auto-immune
disorders, (e.g., Rheumatoid arthritis (RA), lupus erythematosus, scleroderma, etc.);

22. Subject has received a live or attenuated vaccine within 12 weeks prior to enrolling
in the trial; or

23. Positive finding in Interferon-gamma-release assay testing (IGRA-T). In cases where at
the screening visit the IGRA result is indeterminate, the subject will have a PPD skin
test performed, provided that the screening period timeframe can be maintained. If
not, the subject will not be enrolled in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish
pharmacokinetic similarity of BI 695501 to adalimumab.
Trial website
https://clinicaltrials.gov/show/NCT02045979
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications