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

Viatris Innovation GmbH

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Selatogrel

Study type

Interventional

Funder types

Industry

Identifiers

NCT04557280

ID-076-105

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
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 design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 3 patient groups

Treatment A: liquid formulation via auto-injector

Experimental group

Description:

Selatogrel 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.

Treatment B: liquid formulation via syringe

Experimental group

Description:

Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe.

Treatment C: lyophilizate-based formulation via syringe

Experimental group

Description:

Selatogrel will be administered as a reconstituted lyophilizate-based formulation for injection.

Treatment:

Drug: Selatogrel