NCT06647810

Brief Summary

This trial aims to test how two different formulations of BI 690517 are taken up by the body and how probenecid influences the amount of BI 690517 in the blood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

November 13, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

29 days

First QC Date

October 17, 2024

Last Update Submit

January 7, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)

    For the relative bioavailability of BI 690517.

    Up to day 3.

  • Cmax (maximum measured concentration of BI 690517 in plasma)

    For the relative bioavailability of BI 690517.

    Up to day 3.

  • AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)

    For the drug interaction of BI 690517 with probenecid.

    Up to day 3.

  • Cmax (maximum measured concentration of BI 690517 in plasma)

    For the drug interaction of BI 690517 with probenecid.

    Up to day 3.

Secondary Outcomes (2)

  • AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)

    Up to day 3.

  • AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)

    Up to day 3.

Study Arms (3)

BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2

EXPERIMENTAL
Drug: BI 690517 formulation 1Drug: BI 690517 formulation 2Drug: Probenecid

BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1

EXPERIMENTAL
Drug: BI 690517 formulation 1Drug: BI 690517 formulation 2Drug: Probenecid

Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2

EXPERIMENTAL
Drug: BI 690517 formulation 1Drug: BI 690517 formulation 2Drug: Probenecid

Interventions

BI 690517 formulation 1DRUG

BI 690517 formulation 1

Also known as: Vicadrostat
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2
BI 690517 formulation 2DRUG

BI 690517 formulation 2

Also known as: Vicadrostat
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2
ProbenecidDRUG

Probenecid

Also known as: Probenecid Biokanol®
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects according to the assessment of the investigator, as 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 55 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)

You may not qualify if:

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed 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 45 to 90 bpm (beats per minute)
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

MeSH Terms

Interventions

Probenecid

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 18, 2024

Study Start

November 13, 2024

Primary Completion

December 12, 2024

Study Completion

January 7, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Locations

DE(1)