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About
This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild and moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of selatogrel (ACT-246475).
Enrollment
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Inclusion criteria
All participants (Groups 1,2 and 3)
Additional principal inclusion criteria for participants with hepatic impairment (Groups 1 and 2)
Hepatic impairment due to liver cirrhosis according to the Child-Pugh classification:
Systolic blood pressure (SBP) 95-160 mmHg, diastolic blood pressure (DBP) 60-95 mmHg, and pulse rate 50-100 bpm (inclusive), measured on the same arm, after 5 minutes in the supine position at screening and on Day 1 (pre-dose).
Estimated glomerular filtration rate (eGFR) at screening using the Modification of Diet in Renal Disease (MDRD) formula of:
Stable concomitant medications for at least 3 weeks prior to screening and up to Day 1 and expected to be stable during the conduct of the study.
Additional principal inclusion criteria for healthy participants (Group 3)
Normal blood pressure measured on the same arm, after 5 minutes in the supine position at screening and on Day 1 pre-dose defined as:
eGFR greater than or equal to 80 mL/min/1.73 m2 at screening using the MDRD formula.
Exclusion criteria
All participants (Groups 1, 2 and 3)
Additional exclusion criteria for participants with hepatic impairment (Groups 1 and 2)
Additional exclusion criteria for healthy participants (Group 3)
Primary purpose
Allocation
Interventional model
Masking
24 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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