HealthyPhase 1NCT03195088
Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects
A Phase 1 study testing BI 473494 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects. The secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 473494
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jul 2017to 14 Nov 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure [BP], Pulse Rate [PR]), 12-lead Electrocardiogram [ECG], and clinical laboratory tests
- Age of 18 to 45 years (incl.)
- Body Mass Index [BMI] of 20.0 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice [GCP] and local legislation
Who cannot join
- Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR] or Electrocardiogram [ECG]) is 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, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 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
- Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- Further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 473494 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)
The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects.
The secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing.
- Conditions
- Healthy
- Being tested
- BI 473494, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 473494Drug
Solution for injection
PlaceboDrug
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection. Receives: Drug: Placebo |
| BI 473494 35 μg | Experimental | Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection. Receives: Drug: BI 473494 |
| BI 473494 75 μg | Experimental | Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection. Receives: Drug: BI 473494 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Drug-related Adverse Events (AEs) Analysed as Investigator Defined Drug-related AEs
Percentage of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented. Medical judgment was used to determine the relationship between the AEs and the study medication, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Measured: From drug administration until End of trial (EOT), up to 40 days.
Secondary outcomes (2)
Area Under the Concentration-time Curve of BI 473494 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)
AUC0-tz, area under the concentration-time curve of BI 473494 over the time interval from 0 to the last quantifiable time point is presented.
Measured: Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1
Maximum Measured Concentration of BI 473494 (Cmax)
Cmax, maximum measured concentration of BI 473494 is presented.
Measured: Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m 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.
- First posted22 Jun 2017
- Study start27 Jul 2017
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Why it stopped: Terminated (Business Reasons)
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195088
- Sponsor's protocol ID
- 1400-0001
- Other IDs
- 2016-003224-24, 2016
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2017
- Last updated
- 14 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 473494 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)
- ClinicalTrials.gov ID
- NCT03195088
- Acronym / sponsor ID
- 1400-0001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated (Business Reasons)
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Posted 22 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects.
The secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboHealthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection. |
| BI 473494 35 μg | Experimental | Drug: BI 473494Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection. |
| BI 473494 75 μg | Experimental | Drug: BI 473494Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure [BP], Pulse Rate [PR]), 12-lead Electrocardiogram [ECG], and clinical laboratory tests
- Age of 18 to 45 years (incl.)
- Body Mass Index [BMI] of 20.0 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice [GCP] and local legislation
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR] or Electrocardiogram [ECG]) is 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, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 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 473494Solution for injection | Drug | BI 473494 35 μg, BI 473494 75 μg |
| PlaceboSolution for injection | Drug | Placebo |
Primary outcome
Percentage of Participants With Drug-related Adverse Events (AEs) Analysed as Investigator Defined Drug-related AEs
Time frame: From drug administration until End of trial (EOT), up to 40 days.
Percentage of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented. Medical judgment was used to determine the relationship between the AEs and the study medication, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
2 secondary outcomes
Area Under the Concentration-time Curve of BI 473494 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)
Time frame: Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1
Maximum Measured Concentration of BI 473494 (Cmax)
Time frame: Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 473494 in people with Healthy, run by Boehringer Ingelheim at 1 site 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 8 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 14 Jul 2022. 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 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. 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 22 Jun 2022). 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 Participants With Drug-related Adverse Events (AEs) Analysed as Investigator Defined Drug-related AEs (time frame: From drug administration until End of trial (EOT), up to 40 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2022.