Anzhen Hospital
Beijing, 100029, China
Location status: Recruiting
NCT Number: NCT07615868
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 1
Beijing, 100029, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
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.
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
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
Time frame: Up to 36 hours post-dose
The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax
Time frame: Up to 36 hours post-dose
The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax
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
Contact information is provided by the study sponsor or research team.
Viatris Innovation GmbH
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07711106
Arterial Occlusive Diseases, Arteriosclerosis
Saint Petersburg, Russia
View Trial DetailsNCT07696533
Chronic Coronary Syndrome, Obstructive Coronary Artery Disease
Harrow, United Kingdom
View Trial DetailsNCT07195149
Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD
Bialystok, Poland
View Trial DetailsNCT07638137
Angina (Stable), Angina Pectoris
Leganés, Madrid, Spain
View Trial Details