- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07652723
A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants
Open-label Randomized, Three-fold Cross-over, Single-center Interaction Study to Investigate the Influence of Multiple Doses of Acetylsalicylic Acid (ASA) (Aspirin) on the Pharmacodynamics of BAY 3389934 in Healthy Participants.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bayer Clinical Trials Contact
- Número de teléfono: 0018888422937
- Correo electrónico: clinical-trials-contact@bayer.com
Ubicaciones de estudio
-
-
Florida
-
Miami, Florida, Estados Unidos, 33014
- Reclutamiento
- Clinical Pharmacology of Miami, LLC - Cardiology Department
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests, and cardiac monitoring.
- Body mass index within the range 18.0 to 29.9 kg/m^2 (inclusive) at screening visit.
- Male or female (Women of Non-Childbearing Potential [WONCBP]) Contraceptive use by participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants: Participants are eligible to participate if they agree to the following during the study intervention period up to at least 1 day after end of infusion of study intervention to ensure sufficient elimination of BAY3389934 (5 times the elimination half-life of BAY3389934 is approximately 5 hours):
- Refrain from donating sperm
PLUS, either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
Must agree to use contraception /barrier as detailed below:
- Agree to use a male condom with female partner use of an additional highly effective contraceptive method with a failure rate of < 1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
- Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person
- Female participants: A female participant is eligible to participate if she is a WONCBP.
- A WONCBP must have a negative highly sensitive pregnancy test (serum) within 24 hours before the first dose of study intervention, the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
- Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator.
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal.
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication.
- Known severe allergies, e.g. allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions.
- Aspirin hypersensitivity/ allergy.
- Febrile illness within 2 weeks before the start of the first study intervention.
- Known or suspected liver disorders and bile secretion/flow (cholestasis, also history of it).
- History of Morbus Meulengracht (Gilbert´s syndrome) or total bilirubin levels above ULN at screening.
- History of known or suspected malignant tumors.
- Tendency to develop keloids or major scars after injuries.
- Participants experienced surgery (6-months prior to first study intervention), or IM injection (2-week prior to first study intervention).
- Known disorders with increased bleeding risk (e.g., periodontosis, symptomatic hemorrhoids, acute gastritis, peptic ulcer, vascular malformations and also history of it).
- Known sensitivity to common causes of bleeding or bruises (e.g., nasal).
- Known congenital or acquired coagulation disorders (e.g. von Willebrand's disease, hemophilia, platelet dysfunction, etc.).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Treatment sequence A-B-C
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
Experimental: Treatment sequence A-C-B
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
Experimental: Treatment sequence B-A-C
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
Experimental: Treatment sequence B-C-A
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
Experimental: Treatment sequence C-A-B
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
Experimental: Treatment sequence C-B-A
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of participants with treatment-emergent adverse events (TEAEs)
Periodo de tiempo: From first dose of study intervention until 14 days after last study intervention
|
An AE is any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention.
|
From first dose of study intervention until 14 days after last study intervention
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Ratios to baseline of Activated Partial Thromboplastin Time (aPTT) 4h and 5h after baseline
Periodo de tiempo: 4 hours and 5 hours after baseline
|
4 hours and 5 hours after baseline
|
|
Ratios to baseline of Prothrombin Time (PT) 4 h and 5 h after baseline
Periodo de tiempo: 4 hours and 5 hours after baseline
|
4 hours and 5 hours after baseline
|
|
Maximum ratio to baseline of Activated Partial Thromboplastin Time (aPTT) from baseline to 24 h post dose
Periodo de tiempo: Baseline and 24 hours post dose
|
Baseline and 24 hours post dose
|
|
Maximum ratio to baseline of Prothrombin Time (PT) from baseline to 24 h post dose
Periodo de tiempo: Baseline and 24 hours post dose
|
Baseline and 24 hours post dose
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 22366
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .