HealthyPhase 1NCT02606903

Pharmacokinetics and Safety of BI 695501 Administered Via Prefilled Syringe or Autoinjector

A Phase 1 study testing BI 695501 prefilled syringe and BI 695501 autoinjector in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 695501 prefilled syringe and BI 695501 autoinjector
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteBelgium
Study dates: 28 Oct 2015to 4 Oct 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male, non-athletic* Caucasian subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure [BP], pulse rate [PR]), 12-lead ECG, and clinical laboratory tests.
Age between 18 and 65 years (inclusive)
BMI of 18 to 30 kg/m2 (inclusive)
BMI 18 to <20, or
BMI 20 to <25, or
BMI 25 to <=30

Show all 9Show fewer

Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and local legislation.
Subjects agree to use an acceptable method of contraception during the trial and for 6 month after the dose of trial drug.
Non-athletic defined as person performing no more than one hour of exercise per week

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) that deviates from normal and judged as clinically relevant by the investigator.
Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders or diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
History of relevant orthostatic hypotension, fainting spells, or blackouts.
Chronic or relevant acute infections.
Positive result for HIV, HBV, and hepatitis C (Hep C) at screening.
History of relevant allergy or hypersensitivity including allergy to the trial medication, its excipients or device materials (e.g. natural rubber or latex).

Show all 24Show fewer

Intake of drugs with a long half-life (more than 24 hours) within 30 days or less than 5 half-lives of the respective drug prior to administration of trial medication.
Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial.
Previous exposure to a biologic drug.
Intake of an investigational drug in another trial within 2 months prior to intake of trial medication in this trial or intake of an investigational drug during the course of this trial.
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
Inability to refrain from smoking during days of confinement at the trial site.
Alcohol abuse (consumption of more than 4 units/day).
Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the trial medication administration and until Day 14 post trial medication administration; and/or to limit alcohol intake to a maximum of 3 units per day until e.o.t.
Drug abuse or positive drug screening.
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial.
Intention to perform excessive physical activities within 1 week prior to administration of trial medication or contact sport during the entire trial and unwilling to avoid vigorous exercise for 14 days post dosing.
Inability to comply with dietary regimen of trial site.
Any out-of-range laboratory values considered clinically significant by the investigator; subjects with creatine kinase (CK) values 2 times the upper limit of normal (ULN) at Day -1 are excluded from participation.
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because he is considered not able to understand and comply with trial requirements, or has a condition that would not allow safe participation in the trial.
Subjects with any immunological disorders or auto-immune disorders, (e.g., RA, lupus erythematosus, scleroderma, etc.).
Subject has received a live vaccine within 12 weeks prior to enrolling in the trial.
History of TB or positive finding in IGRA.
Evidence of skin irritation or infection at the planned injection place.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

SGS Belgium NV Research Unit Stuivenberg
Antwerp, 2060

Other trials in Belgium

About this study

Official title: Randomized, Single-dose, Parallel-arm, Open-label Phase I Trial to Investigate and Compare the Pharmacokinetics, Safety and Tolerability of BI 695501 Administered Subcutaneously Via Prefilled Syringe or Autoinjector

To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector

Conditions: Healthy
Being tested: BI 695501 prefilled syringe, BI 695501 autoinjector

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 695501 prefilled syringeDrug
BI 695501 autoinjectorDrug

Study groups in NCT02606903
Study group	Role	What they receive
BI 695501 prefilled syringe	Experimental	Not described Receives: Drug: BI 695501 prefilled syringe
BI 695501 autoinjector	Experimental	Not described Receives: Drug: BI 695501 autoinjector

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Measured Concentration of BI 695501 in Plasma (Cmax)
Maximum measured concentration of BI 695501 in plasma (Cmax). The rate and extent of absorption of BI 695501 by assessment of maximum plasma concentration following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.
Measured: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.
Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to 1032 Hours After Dose (AUC0-1032)
Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to 1032 hours after dose (AUC0-1032). The rate and extent of absorption of BI 695501 by assessment of AUC0-1032 following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.
Measured: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h 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-infinity)
Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) based on observed concentration at time of last measurable concentration. The rate and extent of absorption of BI 695501 by assessment of (AUC0-∞) following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.
Measured: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.

Secondary outcomes (1)

Number of Subjects With Drug-related Adverse Events (AEs)
Number of subjects with drug-related Adverse Events (AEs). Any event with an onset after the administration of the trial medication up to a period of 70 days 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.
Measured: From the first drug administration until 43 days observation period after drug administration and up to 70 days safety follow up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 20154 Oct 2016

First posted17 Nov 2015 (estimated)
Study start28 Oct 2015
Primary completion7 Sep 2016
Study completion4 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02606903
Sponsor's protocol ID: 1297.6
Other IDs: 2015-003029-32, 2015
Status last verified: Jun 2018
First submitted: 16 Nov 2015
Last updated: 27 Dec 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Single-dose, Parallel-arm, Open-label Phase I Trial to Investigate and Compare the Pharmacokinetics, Safety and Tolerability of BI 695501 Administered Subcutaneously Via Prefilled Syringe or Autoinjector
ClinicalTrials.gov ID: NCT02606903
Acronym / sponsor ID: 1297.6
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 28 Oct 2015 (actual)
Primary completion: 7 Sep 2016 (actual)
Study completion: 4 Oct 2016 (actual)
First posted: 17 Nov 2015 (estimated)
Results: Posted 27 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BI 695501 prefilled syringe	Experimental	Drug: BI 695501 prefilled syringe
BI 695501 autoinjector	Experimental	Drug: BI 695501 autoinjector

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Healthy male, non-athletic* Caucasian subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure [BP], pulse rate [PR]), 12-lead ECG, and clinical laboratory tests.
Age between 18 and 65 years (inclusive)
BMI of 18 to 30 kg/m2 (inclusive)
BMI 18 to <20, or
BMI 20 to <25, or

Key exclusion criteria (24 listed)

Any finding in the medical examination (including BP, PR or ECG) that deviates from normal and judged as clinically relevant by the investigator.
Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders or diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
History of relevant orthostatic hypotension, fainting spells, or blackouts.
Chronic or relevant acute infections.
Positive result for HIV, HBV, and hepatitis C (Hep C) at screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 695501 prefilled syringe	Drug	BI 695501 prefilled syringe
BI 695501 autoinjector	Drug	BI 695501 autoinjector

Primary outcome

Maximum Measured Concentration of BI 695501 in Plasma (Cmax)
Time frame: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.
Maximum measured concentration of BI 695501 in plasma (Cmax). The rate and extent of absorption of BI 695501 by assessment of maximum plasma concentration following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.
Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to 1032 Hours After Dose (AUC0-1032)
Time frame: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.
Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to 1032 hours after dose (AUC0-1032). The rate and extent of absorption of BI 695501 by assessment of AUC0-1032 following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.
Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
Time frame: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h 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-infinity) based on observed concentration at time of last measurable concentration. The rate and extent of absorption of BI 695501 by assessment of (AUC0-∞) following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.

1 secondary outcome

Number of Subjects With Drug-related Adverse Events (AEs)
Time frame: From the first drug administration until 43 days observation period after drug administration and up to 70 days safety follow up period

Results and safety

Results posted to the registry on 27 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 695501 Autoinjector (AI)	35	35
BI 695501 Pre-filled Syringe (PFS)	36	36

Primary outcome: Maximum Measured Concentration of BI 695501 in Plasma (Cmax)

Time frame: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: Micro-gram (µg) per milliliter (mL)

Measure	BI 695501 Autoinjector (AI) n = 35	BI 695501 Pre-filled Syringe (PFS) n = 36
Value	3.79 (27.4)	3.48 (51.0)

BI 695501 Autoinjector (AI) vs BI 695501 Pre-filled Syringe (PFS): Ratio of adjusted geometric means (%): 110.19 (90% CI 96.80 to 125.44), ANOVA

Population analysed: Pharmacokinetic analysis set (PKS): The PKS consisted of all randomized subjects who received the single dose of trial medication, had at least one evaluable primary pharmacokinetic parameter, and were without important protocol deviations or violations thought to significantly affect the pharmacokinetics of BI 695501.

Primary outcome: Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to 1032 Hours After Dose (AUC0-1032)

Measure	BI 695501 Autoinjector (AI) n = 35	BI 695501 Pre-filled Syringe (PFS) n = 35
Value	1810 (47.5)	1840 (47.1)

BI 695501 Autoinjector (AI) vs BI 695501 Pre-filled Syringe (PFS): Ratio of adjusted geometric means (%): 100.14 (90% CI 85.15 to 117.76), ANOVA

Primary outcome: Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)

Measure	BI 695501 Autoinjector (AI) n = 35	BI 695501 Pre-filled Syringe (PFS) n = 35
Value	2080 (58.2)	2110 (58.0)

BI 695501 Autoinjector (AI) vs BI 695501 Pre-filled Syringe (PFS): Ratio of adjusted geometric means (%): 100.22 (90% CI 82.13 to 122.29), ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the first drug administration until 43 days observation period after drug administration and up to 70 days safety follow up period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 695501 Autoinjector (AI)	0 of 35 (0%)	28 of 35 (80%)	Not reported
BI 695501 Pre-filled Syringe (PFS)	0 of 36 (0%)	23 of 36 (63.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 695501 prefilled syringe and BI 695501 autoinjector in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Measured Concentration of BI 695501 in Plasma (Cmax) (time frame: PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02606903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.