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NCT03145038
Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects
Phase 1 trial testing Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed in Pharmacokinetics in 30 participants. Completed in 9 October 2017.
29 August 2017
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 16 May 2017 |
| Primary completion | 29 August 2017 |
| Estimated completion | 9 October 2017 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed — full drug profile →
- Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted — full drug profile →
- Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed — full drug profile →
- Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast — full drug profile →
- Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast
- Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast — full drug profile →
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 45, male only, with Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat in the treatment of heart failure in paediatric patients is planned under the paediatric investigational plan (PIP). In order to administer vericiguat to children, a vericiguat paediatric formulation is needed. This paediatric formulation is characterized in this study prior to its use in paediatric patients.
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 NCT03145038
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03145038 (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: 29 December 2021
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/NCT03145038.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing