A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems

Sponsor
Cambridge University Hospitals NHS Foundation Trust
Study ID
NCT03098680
Phase
PHASE1
Status
Terminated

Conditions

  • Cardiovascular System Disease
  • Drug-Related Side Effects and Adverse Reactions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Albuterol Sulfate — DRUG
    see arm/group descriptions
  • Nicardipine Hydrochloride — DRUG
    see arm/group descriptions
  • Dobutamine Hydrochloride — DRUG
    see arm/group descriptions
  • Phenylephrine Hydrochloride — DRUG
    see arm/group descriptions
  • Verapamil Hydrochloride — DRUG
    see arm/group descriptions
  • Phentolamine Mesylate — DRUG
    see arm/group descriptions
  • Placebo — DRUG
    see arm/group descriptions

Study Details

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.

Key Dates

Start date
Apr 24, 2017
Status verified
Mar 2021
Primary completion
Feb 29, 2020
Completion
Feb 29, 2020

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group A (Placebo, Salbutamol, Nicardipine, Dobutamine)
    Participants will receive each drug, to be given on separate study days. The drugs will be given as a 3 stage infusion with dose increasing at each stage. Each stage will be 30 minutes in duration. Placebo; Salbutamol(Albuterol) Sulfate (Dose: 2mcg/min, 5mcg/min, 10mcg/min); Nicardipine Hydrochloride (Dose: 1mg/hr, 2.5mg/hr, 5mg/hr); Dobutamine Hydrochloride (Dose: 1mcg/kg/min, 2.5mcg/kg/min, 5mcg/kg/min)
  • Experimental: Group B (Placebo, Phenylephrine, Verapamil, Phentolamine)
    Participants will receive each drug, to be given on separate study days. The drugs will be given as a 3 stage bolus with dose increasing at each stage. Each stage will be 30 minutes apart. Placebo; Phenylephrine Hydrochloride (Dose: 100mcg, 200mcg, 300mcg); Verapamil Hydrochloride (Dose: 1mg, 2.5mg, 5mg); Phentolamine Mesylate (Dose: 1mg, 2mg, 3mg)

Primary Outcome Measure

Heart rate [ Time Frame: At every study visit (each lasting up to 8 hours) ]

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