American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215, United States
NCT Number: NCT03842761
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
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Notify Me18 year and older
All sexes
Interventional
Phase 1
San Antonio, Texas, 78215, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria for all trial participants:
Key inclusion for Patient Groups 1 and 2
Key inclusion for Healthy Volunteer group
Key exclusion for all trial participants
Key exclusion for Patient Groups
Tablet
Tablet
Time frame: Up to day 28
Time frame: Baseline and Up to 72 hours
Time frame: Up to 72 hours
Time frame: Up to 72 hours
Time frame: Up to 72 hours
Time frame: Baseline and Up to 28 days
Time frame: Baseline and Up to 28 days
Time frame: Baseline and Up to 28 days
Time frame: Baseline and Up to 28 days
Boehringer Ingelheim
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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