drugset / Trial / NCT03098680
A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
Phase 1
Terminated
18 enrolled
Cambridge University Hospitals NHS Foundation Trust
AstraZeneca · collabUniversity of Cambridge · collab
RandomizedParallel-groupSingle-blindBasic science
Summary
Unwanted effects on the cardiovascular system is one of the most common causes of safety related discontinuation of a drug. This study aims to develop an in silico model of the human cardiovascular system that can be used to predict unwanted cardiovascular effects of drugs. This will be achieved through a drug administration study that will generate comprehensive pharmacokinetic and pharmacodynamic data following the administration of the following drugs, all known to have effects on the cardiovascular system. Half the participants will receive: Placebo, Salbutamol, Nicardipine, Dobutamine and the other half will receive Placebo, Phenylephrine, Verapamil, Phentolamine.
Timeline
- Start
- 2017-04-24
- Primary completion
- 2020-02-29
- Completion
- 2020-02-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dobutamine | Small molecule | 5 ug/kg | — |
| Subject | Nicardipine | Small molecule | 5 mg | — |
| Subject | Phentolamine | Small molecule | 3 mg | — |
| Subject | Phenylephrine | Small molecule | 300 ug | — |
| Subject | Salbutamol | Unknown | 10 ug | — |
| Subject | Verapamil | Other / unclassified | 5 mg | — |