HealthyPhase 1NCT01958060

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers

A Phase 1 study testing BI 1034020 in people with Healthy, run by Boehringer Ingelheim at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous… Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 1034020
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 2 sitesGermany
Study dates: Oct 2013to Apr 2014
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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
Age within the range of 18 to 40 years
Body mass index within the range of 18.5 and 29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Who cannot join

Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement
Any evidence of a clinically relevant concomitant disease.
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
Surgery of the gastrointestinal tract (except appendectomy).
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

1312.1.1 Boehringer Ingelheim Investigational Site
Biberach
1312.1.2 Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1034020 in Healthy Male Volunteers (Partially Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)

Conditions: Healthy
Being tested: BI 1034020, Placebo to BI 1034020

What participants receive

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

BI 1034020Drug
intravenous part
Placebo to BI 1034020Drug
intravenous part

Study groups in NCT01958060
Study group	Role	What they receive
BI 1034020 intravenous part	Experimental	single rising doses Receives: Drug: BI 1034020; Drug: Placebo to BI 1034020
BI 1034020 subcutaneous part	Experimental	single rising doses Receives: Drug: BI 1034020; Drug: Placebo to BI 1034020

What is being measured

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

Percentage of Subjects With Drug Related Adverse Events
Percentage of subjects with investigator defined drug-related adverse events
Measured: from the first drug administration to end of trial, up to 50 days

Secondary outcomes (3)

Cmax
Maximum measured concentration of BI 1034020 in plasma (Cmax).
Measured: 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.
AUC0-inf
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial.
Measured: 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.
AUC0-tz
Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ).
Measured: 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

Timeline

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

Oct 2013Apr 2014

First posted8 Oct 2013 (estimated)
Study startOct 2013
Primary completionApr 2014
Study completionApr 2014

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: Single group
Masking: Single blind
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01958060
Sponsor's protocol ID: 1312.1
Other IDs: 2011-004615-23
Status last verified: Jul 2015
First submitted: 1 Oct 2013
Last updated: 30 Jul 2015
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 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1034020 in Healthy Male Volunteers (Partially Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
ClinicalTrials.gov ID: NCT01958060
Acronym / sponsor ID: 1312.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 35 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 8 Oct 2013 (estimated)
Results: Posted 30 Jul 2015

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: Single group
Masking: Single blind
Number of arms: 2

Arm	Type	Receives
BI 1034020 intravenous part	Experimental	Drug: BI 1034020, Drug: Placebo to BI 1034020single rising doses
BI 1034020 subcutaneous part	Experimental	Drug: BI 1034020, Drug: Placebo to BI 1034020single rising doses

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
Age within the range of 18 to 40 years
Body mass index within the range of 18.5 and 29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Key exclusion criteria (7 listed)

Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement
Any evidence of a clinically relevant concomitant disease.
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
Surgery of the gastrointestinal tract (except appendectomy).
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 1034020intravenous part	Drug	BI 1034020 intravenous part, BI 1034020 subcutaneous part
Placebo to BI 1034020intravenous part	Drug	BI 1034020 intravenous part, BI 1034020 subcutaneous part

Primary outcome

Percentage of Subjects With Drug Related Adverse Events
Time frame: from the first drug administration to end of trial, up to 50 days
Percentage of subjects with investigator defined drug-related adverse events

3 secondary outcomes

Cmax
Time frame: 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.
AUC0-inf
Time frame: 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.
AUC0-tz
Time frame: 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

Results and safety

Results posted to the registry on 30 Jul 2015, 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	10	8
BI 1034020 (5 mg/25 mL - iv)	6	6
BI 1034020 (10 mg/25 mL - iv)	6	6
BI 1034020 (20 mg/25 mL - iv)	5	5
BI 1034020 (50 mg/25 mL - iv)	7	6
BI 1034020 (100 mg/25 mL - iv)	1	1

Primary outcome: Percentage of Subjects With Drug Related Adverse Events

Time frame: from the first drug administration to end of trial, up to 50 days. Number. Unit: percentage of participants

Measure	Placebo n = 8	BI 1034020 (5 mg/25 mL - iv) n = 6	BI 1034020 (10 mg/25 mL - iv) n = 6	BI 1034020 (20 mg/25 mL - iv) n = 5	BI 1034020 (50 mg/25 mL - iv) n = 6	BI 1034020 (100 mg/25 mL - iv) n = 1
Value	37.5	33.3	33.3	0.0	50.0	100.0

Population analysed: Treated Set (TS)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: from the first drug administration to end of trial, up to 50 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 8 (0%)	6 of 8 (75%)	Not reported
BI 1034020 (5 mg/25 mL - iv)	0 of 6 (0%)	3 of 6 (50%)	Not reported
BI 1034020 (10 mg/25 mL - iv)	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
BI 1034020 (20 mg/25 mL - iv)	0 of 5 (0%)	3 of 5 (60%)	Not reported
BI 1034020 (50 mg/25 mL - iv)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
BI 1034020 (100 mg/25 mL - iv)	1 of 1 (100%)	1 of 1 (100%)	Not reported

Limitations and caveats (from the sponsor): Due to a drug-related Serious Adverse event in the first subject of 100 mg BI 1034020 single iv dose group, the trial was prematurely terminated. No further iv dosing was performed and no planned sc dosing scheme was performed in this trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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

2 sites 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 1034020 in people with Healthy, run by Boehringer Ingelheim at 2 sites in Germany.

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: stopped early, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 30 Jul 2015). 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?

Percentage of Subjects With Drug Related Adverse Events (time frame: from the first drug administration to end of trial, up to 50 days). 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 NCT01958060.

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 30 Jul 2015.