The Effect of Reduced Liver Function on Selatogrel Pharmacokinetics

Sponsor
Viatris Innovation GmbH
Study ID
NCT04406896
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Accepted

Interventions

  • Selatogrel — DRUG
    A single subcutaneous injection of 16 mg.

Study Details

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).

Key Dates

Start date
Jul 22, 2020
Status verified
Nov 2022
Primary completion
Oct 23, 2020
Completion
Oct 23, 2020

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Participants with mild hepatic impairment (Group 1)
    Participant with Child-Pugh Grade A Score of 5-6.
  • Experimental: Participants with moderate hepatic impairment (Group 2)
    Participant with moderate hepatic impairment with a Child-Pugh Grade B Score of 7-9.
  • Experimental: Healthy participants (Group 3)

Primary Outcome Measure

The maximum plasma concentration (Cmax) of selatogrel [ Time Frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3. ]

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