Chronic Coronary SyndromePhase 1NCT07615868
A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Chinese Adults With Chronic Coronary Syndrome
A Phase 1 study testing Selatogrel in people with Chronic Coronary Syndrome, run by Viatris Innovation GmbH at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics, and tolerability of a single dose of selatogrel in Chinese adults with chronic coronary syndrome. Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- Selatogrel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2026to 20 Sep 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic coronary syndrome participants defined by the presence of any of the following conditions:
- History of coronary artery disease with coronary artery stenosis confirmed by a coronary catheterization (at any time prior to Screening) / computed tomography (CT) angiogram ≥ 50%.
- Previously documented myocardial infarction occurring more than 3 months prior to Screening.
- Acetylsalicylic acid as mono antiplatelet background therapy stable for at least 1 month prior to Screening.
- Minimum weight of 50.0 kg at Screening.
Who cannot join
- Known liver impairment significantly affecting the hepatic function (e.g., ascites, icterus, signs of coagulopathy).
- End-stage renal failure requiring dialysis.
- Treatment with another investigational small-molecule or peptide drug within 3 months or 5 × t1/2 (whichever is longer) or with an investigational antibody treatment within 6 months prior to Screening.
- History of major medical or surgical disorders, which in the opinion of the investigator, are likely to interfere with the metabolism, or excretion of the trial treatment(s) (appendectomy and herniotomy allowed).
- Concomitant diseases (e.g., advanced liver cirrhosis, mental illness, neurodegenerative disease, terminal malignancy, etc.) or conditions (e.g., inability to communicate well with the investigator in the local language, inability to consent) that, in the opinion of the investigator, may prevent subject from complying with study requirements or may be a confounder for the study interpretation.
- Conditions associated with atherosclerosis:
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- Acute coronary syndrome, percutaneous coronary intervention, Coronary Artery Bypass Grafting, or any intervention for peripheral artery disease within 3 months prior to randomization.
- Acute ischemic stroke or transient ischemic attack within 3 months prior to randomization
- Mitigation of bleeding risks:
- Active internal bleeding, or medical history of recent (< 1 month) bleeding disorders or conditions associated with high risk of bleeding (e.g., clotting disturbances, gastrointestinal bleed, hemoptysis, or any history of intracranial bleeding).
- Hemoglobin ≤ 10 g/dL at Screening.
- Loss of at least 250 mL of blood within 3 months prior to Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial to Assess the Pharmacokinetics, the Pharmacodynamics, and the Tolerability of a Single 16 mg Dose of Selatogrel (ACT-246475) in Chinese Adults With Chronic Coronary Syndrome
The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics, and tolerability of a single dose of selatogrel in Chinese adults with chronic coronary syndrome.
Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body.
Read more
Researchers will compare selatogrel to a placebo (a look-alike substance that contains no drug).
Participants will stay at the research clinic for 3 or 4 days (2 or 3 nights), during which time they will receive a single dose of selatogrel or placebo. A telephone call for post-trial safety follow-up will be done 30-40 days after the participant leaves the clinic.
- Conditions
- Chronic Coronary Syndrome
- Being tested
- Selatogrel, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelatogrelCombination product
Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration.
A single dose of 16 mg selatogrel will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.
Matching placeboCombination product
A single dose of placebo will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.
| Study group | Role | What they receive |
|---|---|---|
| Selatogrel | Experimental | Study treatment is administered in the morning as a subcutaneous single dose. Receives: Combination Product: Selatogrel |
| Placebo | Placebo comparator | Study treatment is administered in the morning as a subcutaneous single dose. Receives: Combination Product: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
Measured: Up to 36 hours post-dose
Area under the plasma concentration-time curve from zero to infinity (AUC0-infinity)
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
Measured: Up to 36 hours post-dose
Maximum plasma concentration (Cmax)
The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax
Measured: Up to 36 hours post-dose
Time to reach maximum plasma concentration (tmax)
The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax
Measured: Up to 36 hours post-dose
Terminal half-life (t1/2)
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
Measured: Up to 36 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start22 Jun 2026
- Primary completion19 Sep 2026
- Study completion20 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatris Innovation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Viatris Innovation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615868
- Sponsor's protocol ID
- ID-076-109
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Assess the Pharmacokinetics, the Pharmacodynamics, and the Tolerability of a Single 16 mg Dose of Selatogrel (ACT-246475) in Chinese Adults With Chronic Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07615868
- Acronym / sponsor ID
- ID-076-109
- Conditions
- Chronic Coronary Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 19 Sep 2026 (actual)
- Study completion
- 20 Sep 2026 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics, and tolerability of a single dose of selatogrel in Chinese adults with chronic coronary syndrome.
Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body.
Researchers will compare selatogrel to a placebo (a look-alike substance that contains no drug).
Participants will stay at the research clinic for 3 or 4 days (2 or 3 nights), during which time they will receive a single dose of selatogrel or placebo. A telephone call for post-trial safety follow-up will be done 30-40 days after the participant leaves the clinic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selatogrel | Experimental | Combination Product: SelatogrelStudy treatment is administered in the morning as a subcutaneous single dose. |
| Placebo | Placebo comparator | Combination Product: Matching placeboStudy treatment is administered in the morning as a subcutaneous single dose. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic coronary syndrome participants defined by the presence of any of the following conditions:
- Acetylsalicylic acid as mono antiplatelet background therapy stable for at least 1 month prior to Screening.
- Minimum weight of 50.0 kg at Screening.
Key exclusion criteria (12 listed)
- Known liver impairment significantly affecting the hepatic function (e.g., ascites, icterus, signs of coagulopathy).
- End-stage renal failure requiring dialysis.
- Treatment with another investigational small-molecule or peptide drug within 3 months or 5 × t1/2 (whichever is longer) or with an investigational antibody treatment within 6 months prior to Screening.
- History of major medical or surgical disorders, which in the opinion of the investigator, are likely to interfere with the metabolism, or excretion of the trial treatment(s) (appendectomy and herniotomy allowed).
- Concomitant diseases (e.g., advanced liver cirrhosis, mental illness, neurodegenerative disease, terminal malignancy, etc.) or conditions (e.g., inability to communicate well with the investigator in the local language, inability to consent) that, in the opinion of the investigator, may prevent subject from complying with study requirements or may be a confounder for the study interpretation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelatogrelSelatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. A single dose of 16 mg selatogrel will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. | Combination product | Selatogrel |
| Matching placeboA single dose of placebo will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. | Combination product | Placebo |
Primary outcome
Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
Time frame: Up to 36 hours post-dose
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
Area under the plasma concentration-time curve from zero to infinity (AUC0-infinity)
Time frame: Up to 36 hours post-dose
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
Maximum plasma concentration (Cmax)
Time frame: Up to 36 hours post-dose
The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax
Time to reach maximum plasma concentration (tmax)
Time frame: Up to 36 hours post-dose
The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax
Terminal half-life (t1/2)
Time frame: Up to 36 hours post-dose
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Viatris Innovation GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selatogrel in people with Chronic Coronary Syndrome, run by Viatris Innovation GmbH at 1 site in China.
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 5 inclusion and 12 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 27 Oct 2026. 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 China. 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. Some participants in this study may receive a placebo. 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 from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) (time frame: Up to 36 hours post-dose). 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?
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 27 Oct 2026.