Trial Outcomes & Findings for Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects (NCT NCT01505491)
NCT ID: NCT01505491
Last Updated: 2019-02-20
Results Overview
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.
COMPLETED
PHASE1
193 participants
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
2019-02-20
Participant Flow
This was phase I, open-label, randomised, parallel-arm, single-dose, active -comparator study with healthy subjects.
Subjects were screened for eligibility to participate in the trial. They attended a specialist sites which ensured strict implementation of inclusion/exclusion criteria and they were not to be entered in trial if any one of the specific entry criteria was violated. They were free to withdraw their consent at any time without penalty or prejudice.
Participant milestones
| Measure |
BI 695501
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
|
Humira®US
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
|
Humira®EU
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
62
|
64
|
|
Overall Study
COMPLETED
|
65
|
61
|
59
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
5
|
Reasons for withdrawal
| Measure |
BI 695501
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
|
Humira®US
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
|
Humira®EU
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
|
|---|---|---|---|
|
Overall Study
Other reason not listed
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Treated Set
Baseline characteristics by cohort
| Measure |
BI 695501
n=67 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
|
Humira®US
n=62 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
|
Humira®EU
n=64 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.3 Years
STANDARD_DEVIATION 8.2 • n=5 Participants • Treated Set
|
24.4 Years
STANDARD_DEVIATION 6.6 • n=7 Participants • Treated Set
|
27.6 Years
STANDARD_DEVIATION 8.9 • n=5 Participants • Treated Set
|
26.1 Years
STANDARD_DEVIATION 8.1 • n=4 Participants • Treated Set
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants • Treated Set
|
62 Participants
n=7 Participants • Treated Set
|
64 Participants
n=5 Participants • Treated Set
|
193 Participants
n=4 Participants • Treated Set
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants • Treated Set
|
7 Participants
n=7 Participants • Treated Set
|
7 Participants
n=5 Participants • Treated Set
|
24 Participants
n=4 Participants • Treated Set
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants • Treated Set
|
3 Participants
n=7 Participants • Treated Set
|
1 Participants
n=5 Participants • Treated Set
|
5 Participants
n=4 Participants • Treated Set
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Treated Set
|
1 Participants
n=7 Participants • Treated Set
|
1 Participants
n=5 Participants • Treated Set
|
2 Participants
n=4 Participants • Treated Set
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants • Treated Set
|
51 Participants
n=7 Participants • Treated Set
|
55 Participants
n=5 Participants • Treated Set
|
162 Participants
n=4 Participants • Treated Set
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=7 Participants • Treated Set
|
0 Participants
n=5 Participants • Treated Set
|
0 Participants
n=4 Participants • Treated Set
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.
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.
Outcome measures
| Measure |
BI 695501
n=67 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
|
Humira®US
n=62 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
|
Humira®EU
n=64 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
2740 Micro-gram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 48.2
|
2390 Micro-gram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 44.3
|
2050 Micro-gram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 53.2
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.
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.
Outcome measures
| Measure |
BI 695501
n=67 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
|
Humira®US
n=62 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
|
Humira®EU
n=64 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
|
|---|---|---|---|
|
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)
|
2480 Micro-gram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 40.0
|
2250 Micro-gram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 37.7
|
1890 Micro-gram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 46.1
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.
Maximum measured concentration of the BI 695501 in plasma (Cmax). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.
Outcome measures
| Measure |
BI 695501
n=67 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
|
Humira®US
n=62 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
|
Humira®EU
n=64 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
|
|---|---|---|---|
|
Maximum Measured Concentration of the BI 695501 in Plasma (Cmax)
|
4.47 Micro-gram/milliliter (μg/mL)
Geometric Coefficient of Variation 34.2
|
4.07 Micro-gram/milliliter (μg/mL)
Geometric Coefficient of Variation 34.2
|
3.74 Micro-gram/milliliter (μg/mL)
Geometric Coefficient of Variation 40.5
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.
Terminal half- life of the BI 695501 in plasma (t1/2).
Outcome measures
| Measure |
BI 695501
n=67 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
|
Humira®US
n=62 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
|
Humira®EU
n=64 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
|
|---|---|---|---|
|
Terminal Half- Life of the BI 695501 in Plasma (t1/2)
|
292 hour
Geometric Coefficient of Variation 104
|
230 hour
Geometric Coefficient of Variation 76.8
|
236 hour
Geometric Coefficient of Variation 98.3
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.
Apparent clearance of the BI 695501 in the plasma after extra-vascular administration (CL/F).
Outcome measures
| Measure |
BI 695501
n=67 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
|
Humira®US
n=62 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
|
Humira®EU
n=64 Participants
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
|
|---|---|---|---|
|
Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F)
|
0.244 Milliliter per minute (mL/min)
Geometric Coefficient of Variation 48.2
|
0.279 Milliliter per minute (mL/min)
Geometric Coefficient of Variation 44.3
|
0.326 Milliliter per minute (mL/min)
Geometric Coefficient of Variation 53.2
|
Adverse Events
BI 695501
Humira®US
Humira®EU
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 695501
n=67 participants at risk
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
|
Humira®US
n=62 participants at risk
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US
|
Humira®EU
n=64 participants at risk
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
19.4%
13/67 • From the first dose of study drug until end of the study, up to 79 days
|
16.1%
10/62 • From the first dose of study drug until end of the study, up to 79 days
|
26.6%
17/64 • From the first dose of study drug until end of the study, up to 79 days
|
|
Infections and infestations
Rhinitis
|
7.5%
5/67 • From the first dose of study drug until end of the study, up to 79 days
|
1.6%
1/62 • From the first dose of study drug until end of the study, up to 79 days
|
1.6%
1/64 • From the first dose of study drug until end of the study, up to 79 days
|
|
Nervous system disorders
Headache
|
25.4%
17/67 • From the first dose of study drug until end of the study, up to 79 days
|
25.8%
16/62 • From the first dose of study drug until end of the study, up to 79 days
|
20.3%
13/64 • From the first dose of study drug until end of the study, up to 79 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
3/67 • From the first dose of study drug until end of the study, up to 79 days
|
8.1%
5/62 • From the first dose of study drug until end of the study, up to 79 days
|
1.6%
1/64 • From the first dose of study drug until end of the study, up to 79 days
|
|
General disorders
Fatigue
|
6.0%
4/67 • From the first dose of study drug until end of the study, up to 79 days
|
0.00%
0/62 • From the first dose of study drug until end of the study, up to 79 days
|
7.8%
5/64 • From the first dose of study drug until end of the study, up to 79 days
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER