A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems

NCT05731908 | Completed Phase 1 FDA Drug

• 1 other identifier: 1378-0016
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this trial is to assess the effect of mild and moderate hepatic impairment (Child-Pugh classification A and B) on the pharmacokinetics, safety, and tolerability of BI 690517 in comparison with a control group with normal hepatic function.

Conditions

Liver Diseases; Healthy

Outcome Measures

Primary Outcomes (2)

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

  Up to 4 days

• Maximum measured concentration of the analyte in plasma (Cmax)

  Up to 4 days

Secondary Outcomes (1)

• 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)

  Up to 4 days

Study Arms (3)

BI 690517 mild hepatic impairment (Child-Pugh A)

EXPERIMENTAL

Drug: BI 690517

BI 690517 normal hepatic function

EXPERIMENTAL

control group

Drug: BI 690517

BI 690517 moderate hepatic impairment (Child-Pugh B)

EXPERIMENTAL

Drug: BI 690517

Interventions

BI 690517 DRUG

BI 690517

Also known as: Vicadrostat

BI 690517 mild hepatic impairment (Child-Pugh A); BI 690517 moderate hepatic impairment (Child-Pugh B); BI 690517 normal hepatic function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged at least 18 years at screening
• Body mass index of 18.5 to 36.0 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
• Women of childbearing potential1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
• Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points)
• Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electric Cardiogram, and clinical laboratory tests at both screening and admission to trial site, with the exception of findings that in the opinion of the investigator are consistent with the participant's hepatic impairment.
• Healthy subjects according to the following criteria: the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
• Individually matched to participants with hepatic impairment according to sex, age, and weight

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 measurements of blood pressure and pulse rate out of range considered clinically significant by the investigator
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, except for laboratory values outside the reference range due to underlying disease
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, appendectomy or simple hernia repair)
• 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
• Relevant chronic or acute infections

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• IQVIA global CRO: collaborator

Study Sites (2)

Omega Research Orlando, LLC

Orlando, Florida, 32808, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 16, 2023
• Study Start: February 21, 2023
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)