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

First listed
May 29, 2020
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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