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

NCT03098680 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-03-22

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Albuterol Sulfate

see arm/group descriptions

DRUG

Nicardipine Hydrochloride

see arm/group descriptions

DRUG

Dobutamine Hydrochloride

see arm/group descriptions

DRUG

Phenylephrine Hydrochloride

see arm/group descriptions

DRUG

Verapamil Hydrochloride

see arm/group descriptions

DRUG

Phentolamine Mesylate

see arm/group descriptions

DRUG

Placebo

see arm/group descriptions

Sponsors & Collaborators

Principal Investigators

  • Joseph Cheriyan, MBCHB, MA, FRCP · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098680 on ClinicalTrials.gov