drugset / Trial / NCT03145038
Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects
Non-randomizedCrossoverOpen-labelOther
Summary
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.
Timeline
- Start
- 2017-05-16
- Primary completion
- 2017-08-29
- Completion
- 2017-10-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vericiguat | Other / unclassified | 2.5 mg | Oral |
| Subject | Vericiguat | Other / unclassified | 10 mg | Oral |
Indications
No indication recorded.