Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 685509 Over 28 Days in Patients With Mild and Moderate Hepatic Impairment and of Single Oral BI 685509 Dose Compared to Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- BI 685509
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- The percentage of subjects with drug-related Adverse Events (AEs) among different dose regimes over each up-titration
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment [Child-Turcotte-Pugh (CTP) classification A and B] over different dose regimes of BI 685509 compared to placebo. A secondary objective is to investigate pharmacokinetics of different doses of BI 685509 in patients with mild to moderate hepatic impairment (CTP A and CTP B). In addition, another secondary objective is to compare safety, tolerability, and pharmacokinetics in patients with mild to moderate hepatic impairment (CTP A and CTP B) of single BI 685509 dose to individually matched healthy volunteers
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose group 1
Low Dose
Intervention: BI 685509
Dose group 1
Low Dose
Intervention: Placebo
Dose group 2
Medium Dose
Intervention: BI 685509
Dose group 2
Medium Dose
Intervention: Placebo
Dose group 3
High Dose
Intervention: BI 685509
Dose group 3
High Dose
Intervention: Placebo
Dose Group 4
Dose for healthy volunteers dependent on results from prior dose groups with patients
Intervention: BI 685509
Dose Group 4
Dose for healthy volunteers dependent on results from prior dose groups with patients
Intervention: Placebo
Outcomes
Primary Outcomes
The percentage of subjects with drug-related Adverse Events (AEs) among different dose regimes over each up-titration
Time Frame: Up to day 28
Secondary Outcomes
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady)(Up to 72 hours)
- AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [AUCτ,ss will be AUC0-12,ss for bid dosing](Up to 72 hours)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of the last quantifiable data point)(Baseline and Up to 72 hours)
- Cmax (maximum measured concentration of the analyte in plasma)(Up to 72 hours)
- Change from baseline in body weight(Baseline and Up to 28 days)
- Change from baseline in seated systolic blood pressure (SBP)(Baseline and Up to 28 days)
- Change from baseline in seated diastolic blood pressure (DBP)(Baseline and Up to 28 days)
- Change from baseline in heart rate (HR)(Baseline and Up to 28 days)