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Healthy SubjectsPhase 1NCT04406896

The Effect of Reduced Liver Function on Selatogrel Pharmacokinetics

A Phase 1 study testing Selatogrel in people with Healthy Subjects and Hepatic Impairment, run by Viatris Innovation GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Hepatic Impairment
What is being tested?
Selatogrel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteGermany
Study dates
22 Jul 2020to 23 Oct 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All participants (Groups 1,2 and 3)
  • Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
  • Male or female participant aged between 18 and 79 years (inclusive) at screening.
  • Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
  • Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (pre-dose). They must consistently and correctly use (from screening, during the entire study, and for at least 30 days after last study treatment administration) an acceptable effective method of contraception method, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must have been initiated at least 1 month before treatment administration.
  • Women of non-childbearing potential.
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  • 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:
  • Group 1: Mild hepatic impairment, Child-Pugh A = score 5-6.
  • Group 2: Moderate hepatic impairment, Child-Pugh B = score 7-9.
  • 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:
  • greater than or equal to 60 mL/min/1.73 m2 for participants with mild hepatic impairment (Group 1)
  • greater than or equal to 45 mL/min/1.73 m2 for participants with moderate hepatic impairment (Group 2).
  • 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:
  • SBP 90 to 140 mmHg, DBP 60 to 90 mmHg, and pulse rate 50 to 100 bpm (inclusive) for participants less than 60 years of age.
  • SBP 95 to 160 mmHg, DBP 65 to 95 mmHg, and pulse rate 50 to 100 bpm (inclusive) for participants 60 years and older.
  • eGFR greater than or equal to 80 mL/min/1.73 m2 at screening using the MDRD formula.

Who cannot join

  • All participants (Groups 1, 2 and 3)
  • Pregnant or lactating woman.
  • Previous exposure to selatogrel.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
  • Known hypersensitivity to P2Y12 receptor antagonists or any excipients of the drug formulation.
  • Known platelet disorders.
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  • Legal incapacity or limited legal capacity at screening.
  • Additional exclusion criteria for participants with hepatic impairment (Groups 1 and 2)
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition (e.g., cholecystectomy), which might interfere with the absorption, distribution, metabolism, and excretion (ADME) of the study treatment (except for hepatic impairment, appendectomy, and herniotomy).
  • Acute hepatitis, hepatic cancer, primary biliary cirrhosis, or any form of cholestatic disease.
  • Clinical evidence or suspected acute liver failure as judged by the investigator.
  • Severe ascites and/or pleural effusion.
  • Encephalopathy greater than grade 2.
  • Clinical evidence of current alcohol or drug abuse.
  • Clinically relevant abnormalities on a 12-lead ECG, except for abnormalities related to hepatic impairment, after 5 minutes in the supine position at screening and on Day 1 pre-dose.
  • Additional exclusion criteria for healthy participants (Group 3)
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition (e.g., cholecystectomy), which might interfere with the ADME of the study treatment (except for appendectomy and herniotomy).
  • History or clinical evidence of alcohol or drug abuse within the 3 years prior to screening.
  • Family or personal history of prolonged bleeding or bleeding disorders, intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers.
  • Previous treatment with any prescribed medications or over-the-counter medications within 2 weeks or 5 times the terminal half-life (t½), whichever is longer prior to study treatment administration (excludes contraceptives and hormone replacement therapy).

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CRS Clinical Research Services

    Kiel, 24105

Other trials in Germany

About this study

Official title: An Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of Selatogrel in Subjects With Mild and Moderate Hepatic Impairment Compared to Matched Healthy Subjects

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).

Being tested
Selatogrel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelatogrelDrug

    Also called ACT-246475

    A single subcutaneous injection of 16 mg.

Study groups in NCT04406896
Study groupRoleWhat they receive
Participants with mild hepatic impairment (Group 1)ExperimentalParticipant with Child-Pugh Grade A Score of 5-6.
Receives: Drug: Selatogrel
Participants with moderate hepatic impairment (Group 2)ExperimentalParticipant with moderate hepatic impairment with a Child-Pugh Grade B Score of 7-9.
Receives: Drug: Selatogrel
Healthy participants (Group 3)ExperimentalNot described
Receives: Drug: Selatogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The maximum plasma concentration (Cmax) of selatogrel

    Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.

  2. Time to reach Cmax (tmax)

    Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.

  3. Area under the plasma concentration-time curves (AUC0-t) of selatogrel

    Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.

  4. The area under the plasma concentration-time curve from zero to infinity (AUC0-inf) of selatogrel

    Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.

  5. Terminal half-life (t½) of selatogrel

    Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.

  6. The apparent clearance (CL/F) of selatogrel

    Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.

  7. The apparent volume of distribution (Vz/F) of selatogrel

    Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.

  8. Plasma protein binding of selatogrel

    Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose and post-dose).

Secondary outcomes (7)

  1. Change from baseline in supine blood pressure

    Measured: Multiple predefined times on Day 1 (pre-dose) up to Day 3.

  2. Change from baseline in temperature

    Measured: Multiple predefined times on Day 1 (pre-dose) up to Day 3.

  3. Change from baseline in pulse rate

    Measured: Multiple predefined times on Day 1 (pre-dose) up to Day 3.

  4. Change from baseline in body weight

    Measured: Multiple predefined times on Day 1 (pre-dose) up to Day 3.

  5. Change from baseline in clinical laboratory tests

    Measured: Multiple predefined times on Day 1 (pre-dose) up to Day 3.

  6. Change from baseline at each time point of measurement in ECG variables.

    Measured: Multiple predefined times on Day 1 (pre-dose) up to Day 3.

  7. Inhibition of platelet aggregation

    Measured: Multiple predefined times on Day 1 (pre-dose) up to Day 3.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start22 Jul 2020
  3. Primary completion23 Oct 2020
  4. Study completion23 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Sequential
Model description
Moderate hepatic impaired participants will be dosed after an interim analysis of at least 6 participants with mild hepatic impairment. Healthy participants will be matched to hepatic impaired participants.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04406896
Sponsor's protocol ID
ID-076-108
Other IDs
2020-001315-25
Status last verified
Nov 2022
First submitted
25 May 2020
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Selatogrel in people with Healthy Subjects and Hepatic Impairment, run by Viatris Innovation GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04406896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.

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