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NCT05086952
A Study in Healthy Adult Male Participants to Learn the Way Vericiguat is Absorbed With and Without Food When Taken as a Single Dose in Liquid Form Suitable for Children Compared to a 10 Milligram (mg) Tablet That Releases the Active Substance Immediately
Phase 1 trial testing Vericiguat (BAY1021189) - Intervention A in Heart Failure in 36 participants. Completed in 15 February 2022.
22 December 2021
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 36 |
| Start date | 12 October 2021 |
| Primary completion | 22 December 2021 |
| Estimated completion | 15 February 2022 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Vericiguat (BAY1021189) - Intervention A — full drug profile →
- Vericiguat (BAY1021189) - Intervention B — full drug profile →
- Vericiguat (BAY1021189) - Intervention C — full drug profile →
- Vericiguat (Verquvo, BAY1021189) - Intervention D — full drug profile →
Conditions studied
- Heart Failure — all drugs for Heart Failure →
- Children — all drugs for Children →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 45, any sex, with Heart Failure or Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Researchers are looking for a better way to treat heart failure, a condition in which the heart does not pump blood as well as it should. Heart failure can happen in both adults and children. The study treatment, vericiguat, is already available for doctors to give to adults who have heart failure. It works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation. The current form of vericiguat is a tablet that releases the "active substance" immediately. The "active substance" is the part of the drug that works in the body to treat the condition. Vericiguat is currently only available as a treatment for adults. Researchers think vericiguat could help treat children with heart failure, but think it will be easiest for them to take a liquid treatment. Another study is planned to find out how well vericiguat works in children who have a specific type of heart failure. Before researchers can give vericiguat to children, they must first study different doses and ways of taking vericiguat in adults. In this study, the researchers will study a new liquid form of vericiguat in adults. This form is also known as the "pediatric formulation". In this study, the researchers want to find out how the new pediatric formulation of vericiguat moves into, through, and out of the body compared to the currently approved tablet form for adults. The researchers also want to find out if eating food affects the new pediatric formulation differently than the current tablet form of vericiguat. The study will include about 36 healthy white male participants aged between 18 and 45 years old. During this study, the participants will all take 4 different treatments in different orders. They will take: * a high dose of vericiguat in the new pediatric formulation, with food * a high dose of vericiguat in the new pediatric formulation, without food * a low dose of vericiguat in the new pediatric formulation, with food * a dose of the currently available tablet form, with food While taking each study treatment, the participants will stay at the study site for 4 days. There will be a break of at least 10 days between each treatment. Overall, the participants will be in this study for about 11 weeks. During the study, the participants will: * have blood and urine samples taken * have their overall health and heart health checked * answer questions about how the new pediatric formulation tastes * answer questions about any adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05086952
- Europe PMC full search
- ASCO Meeting Library
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Related trials
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- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
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Other Bayer trials
Trials by the same sponsor.
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- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05086952 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 2 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05086952.
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