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Healthy SubjectsPhase 1NCT04557280

A Comparative Study of Selatogrel (ACT-246475) Formulations in Healthy Subjects

A Phase 1 study testing Selatogrel in people with Healthy Subjects, run by Viatris Innovation GmbH at 1 site in United States.

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

The main purpose is to study the pharmacokinetics of selatogrel (ACT-246475) using different administration modes and formulations. The clinical pharmacology data will be used to support demonstration of bioequivalence and interchangeability of the different formulations. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
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 siteUnited States
Study dates
6 Nov 2020to 19 Dec 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 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
  • Healthy male or female participant aged between 18 and 59 years (inclusive) at screening.
  • Body mass index of 18.0 to 31.9 kg/m2 (inclusive) at screening and a minimum weight of 50.0 kg at screening and on Day -1.
  • Systolic blood pressure 100 to 140 mmHg, diastolic blood pressure 50 to 90 mmHg, and pulse rate 45 to 100 bpm (inclusive), measured on the left arm, after 5 minutes in the supine position at screening and Day-1.
  • 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at screening and on Day-1.
  • Clinical laboratory values are within the standard normal ranges or determined to be clinically insignificant in the opinion of the investigator at screening and on Day -1.
  • Women must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline (i.e., Day -1 of the first period). Women of childbearing potential must consistently and correctly use (from screening, during the entire study, and for at least 30 days after last study treatment injection) an acceptable effective method of contraception, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated at least 1 month before first treatment administration.
  • Women of non-childbearing potential.

Who cannot join

  • Pregnant or lactating woman.
  • Previous exposure to selatogrel (ACT-246475).
  • Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs, P2Y12 receptor antagonists, or any medication with blood-thinning activity (i.e., injectable or oral anticoagulants) within 3 weeks prior to study treatment administration.
  • Treatment with another investigational small molecule drug within 30 days or 5 x terminal half-lives ([t½], whichever is longer) or with an investigational biologic drug within 90 days prior to screening.
  • Known hypersensitivity to P2Y12 receptor antagonists or to excipients used in any of the formulations.
  • History or clinical evidence of alcoholism or drug abuse within 3 years prior to screening.
Show all 10Show fewer
  • History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
  • Family or personal history of prolonged bleeding (e.g., after surgical intervention) or bleeding disorders (e.g., thrombocytopenia, clotting disturbances), intracranial vascular diseases, stroke, transient ischemic attack, reasonable suspicion of vascular malformations, peptic ulcers.
  • Platelet count less than 120 x10^9 per litre at screening and on Day-1.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Altasciences Clinical Kansas, Inc

    Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Randomized, Open-label, 3-period Cross-over Study to Assess the Pharmacokinetics of Selatogrel (ACT-246475) in Healthy Subjects After Subcutaneous Administration by Syringe and Auto-injector

The main purpose is to study the pharmacokinetics of selatogrel (ACT-246475) using different administration modes and formulations. The clinical pharmacology data will be used to support demonstration of bioequivalence and interchangeability of the different formulations.

Being tested
Selatogrel

What participants receive

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

  • SelatogrelCombination product

    Also called ACT-246475

    A single subcutaneous injection of 16 mg.

  • SelatogrelDrug

    Also called ACT-246475

    A single subcutaneous injection of 16 mg.

Study groups in NCT04557280
Study groupRoleWhat they receive
Treatment A: liquid formulation via auto-injectorExperimentalSelatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an auto-injector forming an integral ready-to-use single-dose drug delivery system.
Receives: Combination Product: Selatogrel
Treatment B: liquid formulation via syringeExperimentalSelatogrel will be administered as a liquid formulation in a sealed prefilled syringe.
Receives: Combination Product: Selatogrel
Treatment C: lyophilizate-based formulation via syringeExperimentalSelatogrel will be administered as a reconstituted lyophilizate-based formulation for injection.
Receives: Drug: Selatogrel

What is being measured

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

  1. Area under the plasma concentration-time curve (AUC0-t) of selatogrel

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

  2. 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.

  3. The maximum plasma concentration (Cmax) of selatogrel

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

  4. Time to reach Cmax (tmax)

    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.

Secondary outcomes (7)

  1. Change from baseline in systolic and diastolic supine blood pressure

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

  2. Change from baseline in pulse rate

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

  3. Change from baseline in body weight

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

  4. Change from baseline in the electric activity of the heart (12-lead electrocardiogram)

    Changes in the PQ-, PR-, RR-, and QRS-interval will be measured. In addition, the QTc-interval corrected for heart rate using Bazett's (QTcB) and Fridericia's formula (QTcF) will be assessed.

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

  5. Change from baseline in coagulation laboratory tests

    Blood samples will be taken under fasted conditions and the following tested: prothrombin time and international normalized ratio, as well as activated partial thromboplastin time.

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

  6. Change from baseline in clinical chemistry tests

    Blood samples will be taken under fasted conditions and the following tested: aspartate aminotransferase / alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, total and direct bilirubin, lactate dehydrogenase; creatinine, urea; urate; glucose; cholesterol, triglycerides; sodium, potassium, chloride, calcium; protein, albumin.

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

  7. Change from baseline in clinical hematology tests

    Blood samples will be taken under fasted conditions and the following tested: hemoglobin, hematocrit, erythrocytes, leukocytes; as well as a differential blood count (including basophils, eosinophils, neutrophils, lymphocytes and monocytes); and platelets.

    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 posted21 Sep 2020
  2. Study start6 Nov 2020
  3. Primary completion19 Dec 2020
  4. Study completion19 Dec 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
Randomised
Intervention model
Crossover
Model description
Single-center, randomized, 3-period crossover.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04557280
Sponsor's protocol ID
ID-076-105
Status last verified
Nov 2022
First submitted
7 Sep 2020
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Zenklusen I, Hsin CH, Schilling U, Kankam M, Krause A, Ufer M, Dingemanse J. Transition from Syringe to Autoinjector Based on Bridging Pharmacokinetics and Pharmacodynamics of the P2Y12 Receptor Antagonist Selatogrel in Healthy Subjects. Clin Pharmacokinet. 2022 May;61(5):687-695. doi: 10.1007/s40262-021-01097-9. Epub 2021 Dec 28.

    PubMed 34961905

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Selatogrel in people with Healthy Subjects, run by Viatris Innovation GmbH at 1 site in United States.

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 8 inclusion and 10 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 3 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 United States. 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?

Area under the plasma concentration-time curve (AUC0-t) of selatogrel (time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.). The study lists 5 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 NCT04557280, which also lists 1 linked publication.

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 3 Jul 2025.

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