Inhibition of VAP-1 by Caffeine in Healthy Human Volunteers Study

NCT02098785 | Withdrawn Phase 1

• 1 other identifier: RG_14-045
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Worldwide, liver related morbidity and mortality continue to rise. It is the 5th commonest cause of death in the UK. Liver damage consists of two main components - a) damage to the cells of the liver, called hepatocytes, meaning the liver cannot function properly leading to jaundice (yellow appearance of the skin and/or eyes) and liver failure and b) scarring of the liver, called Cirrhosis, leading to impaired function and inadequate blood flow through the liver with potential to develop into cancer. Manifestations of this state include ascites (fluid in the tummy) and varices (swollen blood vessels in the food pipe). Liver transplant is currently the only curative treatment for end stage chronic liver disease. Unfortunately its high demand has not been matched by an equivalent rise in liver donations and even when a transplant has occurred there are numerous lifestyle effects such as immunosuppression and kidney impairment thus outcome remains poor for many patients. Coffee has been shown to have mortality benefit in humans and drinking two to three cups a day was associated with a 40% reduced risk of developing cirrhosis, particularly alcohol related; and higher the more cups consumed. Previous work has demonstrated coffee reduces the level of fibrosis in the liver by interrupting signalling pathways, blocking the effects of special products, called cytokines, and reducing accumulation of iron. The investigators' hypothesis is that given the potential for caffeine to be used as a treatment in SSAO activity associated diseases it is important to see if the activity of SSAO can be blocked in healthy humans too. The Investigators' aim to examine the effect of caffeine on circulating VAP-1 levels in large numbers of healthy volunteers to assess its potential as an attractive therapeutic target in view of its low toxicity and widespread availability.

Conditions

Liver Disease

Keywords

VAP; liver; hepatology; caffeine

Outcome Measures

Primary Outcomes (1)

• VAP-1 serum levels

  The aim of the trial is to examine whether caffeine blocks vascular adhesion protein-1 (VAP-1) activity in the blood of healthy human volunteers and thus prove to be of medicinal value in liver disease.

  VAP-1 serum levels at 60, 90 and 120 minutes post administration of caffeine citrate (Peyona)

Study Arms (1)

Caffeine citrate (Peyona) 400mg

EXPERIMENTAL

Caffeine Citrate (Peyona) 400mg single dose (20ml oral solution)

Drug: Caffeine citrate

Interventions

Caffeine citrate DRUG

Oral solution

Also known as: Peyona

Caffeine citrate (Peyona) 400mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy human volunteers aged 18-70 inclusive
• No significant medical problems (as determined by a screening questionnaire)
• Written informed consent given by the patient

You may not qualify if:

• Currently pregnant or breast feeding
• Psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study or comply with the requirements of the study
• Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
• Unable to travel for study visit

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

University of Birmingham, UK

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• David Adams, MD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 28, 2014
• Study Start: March 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 19, 2018

Record last verified: 2017-05

Locations

GB (1)