HealthyPhase 1NCT02696616

Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers

A Phase 1 study testing BI 655088 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.

Trial summary

Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 655088
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteBelgium
Study dates: 16 Mar 2016to 14 Feb 2019
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects
Age of 18 to 50 years
Body mass index (BMI) of 18.5 to 29.9 kg/m2
Additional inclusion criteria may apply

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders
Additional exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Belgium1 site

SGS Life Science Services - Clinical Research
Edegem, 2650

Other trials in Belgium

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 655088 Administered by Intravenous Infusion in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel Group Design)

Conditions: Healthy
Being tested: BI 655088, Placebo

What participants receive

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

BI 655088Drug
PlaceboDrug

Study groups in NCT02696616
Study group	Role	What they receive
BI 655088	Experimental	Not described Receives: Drug: BI 655088
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Number of Subjects With Drug-related Adverse Events
The number of subjects with drug-related adverse events.
Measured: up to 99 days after start of drug administration

Secondary outcomes (3)

Maximum Measured Concentration of BI 655088 in Plasma (Cmax)
Maximum measured concentration of BI 655088 in plasma (Cmax).
Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion.
Measured: Up to 2016 hours. See endpoint description for a detailed timeframe.
Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
AUC0-tz (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 to the last quantifiable data point).
Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion.
Measured: Up to 2016 hours. See endpoint description for a detailed timeframe.
Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
AUC0-∞ (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 extrapolated to infinity).
Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion.
Measured: Up to 2016 hours. See endpoint description for a detailed timeframe.

Timeline

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

16 Mar 201614 Feb 2019

First posted2 Mar 2016 (estimated)
Study start16 Mar 2016
Primary completion14 Feb 2019
Study completion14 Feb 2019

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: Single blind
Who is masked: Participant
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02696616
Sponsor's protocol ID: 1339.1
Other IDs: 2014-002413-29, 2014
Status last verified: Apr 2022
First submitted: 26 Feb 2016
Last updated: 25 Jan 2023
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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 655088 Administered by Intravenous Infusion in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel Group Design)
ClinicalTrials.gov ID: NCT02696616
Acronym / sponsor ID: 1339.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 16 Mar 2016 (actual)
Primary completion: 14 Feb 2019 (actual)
Study completion: 14 Feb 2019 (actual)
First posted: 2 Mar 2016 (estimated)
Results: Posted 25 Jan 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
BI 655088	Experimental	Drug: BI 655088
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male subjects
Age of 18 to 50 years
Body mass index (BMI) of 18.5 to 29.9 kg/m2
Additional inclusion criteria may apply

Key exclusion criteria (7 listed)

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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 655088	Drug	BI 655088
Placebo	Drug	Placebo

Primary outcome

Number of Subjects With Drug-related Adverse Events
Time frame: up to 99 days after start of drug administration
The number of subjects with drug-related adverse events.

3 secondary outcomes

Maximum Measured Concentration of BI 655088 in Plasma (Cmax)
Time frame: Up to 2016 hours. See endpoint description for a detailed timeframe.
Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Up to 2016 hours. See endpoint description for a detailed timeframe.
Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Time frame: Up to 2016 hours. See endpoint description for a detailed timeframe.

Results and safety

Results posted to the registry on 25 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	12	12
BI 655088 2 mg	5	4
BI 655088 6 mg	6	6
BI 655088 20 mg	6	6
BI 655088 50 mg	6	6
BI 655088 100 mg	6	6
BI 655088 200 mg	6	6

Primary outcome: Number of Subjects With Drug-related Adverse Events

Time frame: up to 99 days after start of drug administration. Number. Unit: Participants

Measure	Placebo n = 12	BI 655088 2 mg n = 5	BI 655088 6 mg n = 6	BI 655088 20 mg n = 6	BI 655088 50 mg n = 6	BI 655088 100 mg n = 6	BI 655088 200 mg n = 6
Value	2	1	2	1	0	0	0

Population analysed: Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, and disposition.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
2 mg BI	1 of 5 (20%)	4 of 5 (80%)	0 of 5
6 mg BI	0 of 6 (0%)	3 of 6 (50%)	0 of 6
20 mg BI	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
50 mg BI	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
100 mg BI	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
200 mg BI	1 of 6 (16.7%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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 655088 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 4 inclusion and 7 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 25 Jan 2023. 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. Some participants in this study may receive a placebo. 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 25 Jan 2023). 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?

Number of Subjects With Drug-related Adverse Events (time frame: up to 99 days after start of drug administration). 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 NCT02696616.

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 25 Jan 2023.