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HealthyPhase 1NCT03100916

This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood

A Phase 1 study testing BI 690517 and BI 690517 (Reference) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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

The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy male subjects following oral administration of multiple rising doses over 14 days (MRD part). 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 690517 and BI 690517 (Reference)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteGermany
Study dates
5 May 2017to 24 Nov 2017
Phase
Phase 1
Are there results?
None posted in the registry

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 according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP(Blood Pressure), PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
  • Age of 18 to 50 years (incl.)
  • BMI(Body Mass Index) of 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and local legislation
  • Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception with their female partner throughout the study and until one month after the last administration of trial medication. Adequate methods are:
  • Sexual abstinence or
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  • A vasectomy performed at least 1 year prior to screening in combination with a barrier method (condom) or
  • Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner or
  • The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide) Unprotected sexual intercourse with a female partner is not allowed throughout the study and until one month after the last administration of trial medication.

Who cannot join

  • Any finding in the medical examination (including BP, PR or 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
  • Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
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  • 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; orthostatic dysregulation identified during screening or on Day 1)
  • Chronic or relevant acute infections
  • History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients or Synacthen®), previous diagnostic test with Synacthen®
  • 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)
  • Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  • Inability to refrain from smoking on specified trial days
  • Alcohol abuse (consumption of more 30 g per day)
  • 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 one week prior to administration of trial medication or during the trial
  • Inability to comply with dietary regimen of trial site
  • A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
  • A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
  • Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
  • Values for serum sodium and potassium outside normal range at screening
  • Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CRS Clinical Research Services Mannheim GmbH

    Mannheim, 68167

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 690517 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Within Dose Groups) and Effect of Food on the Bioavailability of BI 690517 (Openlabel, Randomised, Two-way Cross-over)

The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy male subjects following oral administration of multiple rising doses over 14 days (MRD part).

Secondary objectives for the MRD part are the exploration of PK (Pharmacokinetic(s)), including dose proportionality, as well as investigation of linearity and PD (Pharmacodynamic(s)) of BI 690517 after multiple dosing.

For the FE (food effect) part, the secondary objective is to investigate the relative bioavailability of BI 690517 under fasted conditions (Reference, R) compared to BI 690517 (single dose) after a high fat high caloric breakfast (Test, T).

Conditions
Healthy
Being tested
BI 690517, Placebo, BI 690517 (Reference)

What participants receive

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

  • BI 690517Drug

    Also called Vicadrostat

    once daily

  • PlaceboDrug

    once daily

  • BI 690517 (Reference)Drug

    Also called Vicadrostat

    Fasting

  • BI 690517Drug

    Also called Vicadrostat

    Non- fasting

Study groups in NCT03100916
Study groupRoleWhat they receive
Dose Ranging ArmExperimentalNot described
Receives: Drug: BI 690517; Drug: Placebo
Food Effect armExperimentalNot described
Receives: Drug: BI 690517 (Reference); Drug: BI 690517

What is being measured

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

  1. [N (%)] of subjects with drug-related Adverse Events

    [N (%)] of subjects with drug-related Adverse Events

    Measured: Day 30

Secondary outcomes (7)

  1. AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose [AUCtau,1 will be AUC0-24])

    AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose [AUCtau,1 will be AUC0-24])

    Measured: 0-24 hours

  2. Cmax (maximum measured concentration of the analyte in plasma) (After the first dose)(Multiple rising dose part)

    Cmax (maximum measured concentration of the analyte in plasma) (After the first dose)(Multiple rising dose part)

    Measured: up to 24 hours

  3. AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)

    AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)

    Measured: 312 - 360 hours

  4. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)

    Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)

    Measured: after 312 hours and up to 360 hours

  5. Cmax (maximum measured concentration of the analyte in plasma) (Food effect part)

    Cmax (maximum measured concentration of the analyte in plasma) (Food effect part)

    Measured: Up to 48 hours

  6. AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Measured: Up to 48 hours

  7. AUC0- tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

    AUC0- tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

    Measured: Up to 48 hours

Timeline

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

  1. First posted4 Apr 2017
  2. Study start5 May 2017
  3. Primary completion24 Nov 2017
  4. Study completion24 Nov 2017

Resources

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03100916
Sponsor's protocol ID
1378-0002
Other IDs
2017-000104-18, 2017
Status last verified
Sep 2024
First submitted
31 Mar 2017
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 690517 and BI 690517 (Reference) 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 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 20 Sep 2024. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

[N (%)] of subjects with drug-related Adverse Events (time frame: Day 30). 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 NCT03100916.

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 20 Sep 2024.

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