A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
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
Outcome
Outcome not reported
Stopped (Enrollment): “Unable to recruit in time before end of PhD studentship”
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 | — |