Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
55
Countries
3
Sites
15
Heart failure with preserved ejection fraction (HFpEF)
The main objective of the trial is to understand the safety and tolerability of MYK-224 in participants with HFpEF.
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company, Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 25 Apr 2024 → 16 Jan 2025
- Decision date (initial)
- 2024-04-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bristol-Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2023-505919-21-00
- WHO UTN
- U1111-1292-8451
- ClinicalTrials.gov
- NCT06122779
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacokinetic, Safety
The main objective of the trial is to understand the safety and tolerability
of MYK-224 in participants with HFpEF.
Secondary objectives 1
- The secondary objective of the trial is to identify the amount of MYK-224 that reaches the bloodstream.
Conditions and MedDRA coding
Heart failure with preserved ejection fraction (HFpEF)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | LLT | 10076396 | Heart failure with preserved ejection fraction | 10007541 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adult patients with stable, symptomatic HFpEF with a normal heart pumping ability.
Exclusion criteria 1
- Some key exclusion criteria include: patients must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The main trial endpoint is the number of side effects that occur within the study
Secondary endpoints 1
- The secondary trial endpoint is a summary of the amount of MYK-224 in the bloodstream.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10873510 · Product
- Active substance
- BMS-986435
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10873509 · Product
- Active substance
- BMS-986435
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10873508 · Product
- Active substance
- BMS-986435
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2, Ballycoolin Ballycoolin
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 12, Other, Code 2, Code 8, Code 9 |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other, Data management |
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2, Ballycoolin Ballycoolin
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 12, Other, Code 2, Code 8, Code 9 |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
Locations
3 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 12 | 5 |
| Poland | Ended | 15 | 3 |
| Spain | Ended | 14 | 7 |
| Rest of world
Canada, United States
|
— | 14 | — |
Investigational sites
Fondazione Toscana Gabriele Monasterio
Cardiology and Cardiovascular Medicine, Via Giuseppe Moruzzi 1, 56124, Pisa
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department of Advanced Biomedical Sciences, Via Sergio Pansini 5, 80131, Naples
ASST Grande Ospedale Metropolitano Niguarda
Cardiology IV, Piazza Dell'ospedale Maggiore 3, 20162, Milan
IRCCS Policlinico San Donato
Cardiology, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Azienda Ospedaliera Papa Giovanni XXIII
S.C. Cardiology, Piazza Oms 1, 24127, Bergamo
Clinical Trials Umed Sp. z o.o.
N/A, Bud A-2, Ul. Pomorska 251, Lodz
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
N/A, Ul. Dr. K. Jaczewskiego 8, 20-954, Lublin
Uniwersytecki Szpital Kliniczny W Bialymstoku
N/A, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Hospital Universitario Virgen De Valme
Internal Medicine, Avenida Bellavista S/n, 41014, Sevilla
University Clinical Hospital Virgen De La Arrixaca
Internal Medicine, Carretera De Cartagena Sn, El Palmar, Murcia
Bellvitge University Hospital
Cardiology, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Universitario Puerta De Hierro De Majadahonda
Cardiology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario Virgen De La Victoria
Cardiology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Clinico Universitario De Valencia
Cardiology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Ramon Y Cajal
Internal Medicine, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-06-04 | 2025-01-21 | 2024-09-02 | 2024-10-03 | |
| Poland | 2024-05-29 | 2025-01-14 | 2024-09-02 | 2024-10-03 | |
| Spain | 2024-04-25 | 2025-01-16 | 2024-05-06 | 2024-10-03 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-30 | Italy | Acceptable 2024-04-15
|
2024-04-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-22 | Italy | Acceptable 2024-04-15
|
2024-08-22 |