A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies, Gastrointestinal, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/15/2019 |
Start Date: | March 6, 2019 |
End Date: | July 24, 2020 |
Contact: | Boehringer Ingelheim |
Email: | clintriage.rdg@boehringer-ingelheim.com |
Phone: | 1-800-243-0127 |
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
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
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
Key Inclusion Criteria for all trial participants:
- Age ≥ 18 years at screening
- Male subjects with partners of child-bearing potential must be willing to use condoms
from the time of the first intake of study drug until completion of follow-up
- Mean Arterial Pressure (MAP) ≥ 85 mmHg at screening visit
Key inclusion for Patient Groups 1 and 2
- If on treatment with non-selective beta blockers (NSBB), stable dose since ≥ 8 weeks
prior to screening, with no planned dose change of the therapy during study conduct.
All other medications stable 4 weeks prior to screening.
- Patient Group 1: Patients with CTP A (with liver stiffness >15 kPa during screening)
and without a previous decompensation event [ascites, variceal hemorrhage,
encephalopathy, or jaundice (except Gilbert's disease or hemolysis when bilirubin will
be almost exclusively indirect hyperbilirubinemia)]
- Patient Group 2: Patients with CTP B (with liver stiffness >15 kPa during screening)
Key inclusion for Healthy Volunteer group
-Subjects who are healthy, according to the investigator's assessment, individually matched
to a participant among Patient Groups 1 and 2 according to the following criteria: age
within ± 5 years, body weight within ± 15%, and gender
Key exclusion for all trial participants
- Ongoing chronic alcohol or drug use, which in the investigator's opinion, makes the
patient an unreliable trial participant or unlikely to complete the trial.
- History of relevant orthostatic hypotension, fainting spells, or blackouts based on
the investigator´s judgment
Key exclusion for Patient Groups
- Patient Group 2: treatment-refractory ascites
- Patient Group 2: recent decompensation event (refractory ascites, recurrent variceal
hemorrhage, recurrent hepatic encephalopathy, spontaneous bacterial peritonitis or
hepatorenal syndrome) within 6 weeks of screening
We found this trial at
1
site
San Antonio, Texas 78215
Phone: +001 (210) 253-3426
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