The influence of ivabradine on the symptoms of neuropathic pain in a healthy volunteer pain model (IIVOP)

Phase 1

• Conditions: europathic Pain; MedDRA version: 16.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-005627-32-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-25
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

- Volunteers who have given written informed consent to participate
- Volunteers who can communicate fluently in English
- Male or female
- Aged 18-64 years
- Absence of any chronic pain medicine
- Volunteers in good general health, including a body mass index (BMI) in the range of 19-35
- Volunteers with a normal resting 12-lead standard ECG including (measured for 1 minute on lead D2): normal sinus rhythm; 60 bpm = HR on resting ECG; PR interval = 210ms; QTcB = 430ms for men and = 450ms for women; QRS duration = 120ms; the results of ECG recordings will be included in the CRF
- Women of child bearing potential must use hormonal based contraception for the duration of the trial and 1 week following the end of their trial participation
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Volunteers with 1 arm
- Pre-existing pain on either forearm
- Previous surgery or tattoo on either forearm
- History of disease associated with neuropathy
- Volunteers who are allergic to ivabradine or capsaicin
- History of personal or familial Long QT Syndrome
- History of cardiac dysrhythmia
- Use of CYP3A4 inhibitors such as ketoconazole, itraconazole, macrolide antibiotics and the anti-retrovirals nelfinavir, nefazodone and ritonavir.
- Use of CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin or St John’s Wort etc.)
- Use of QT interval prolonging medicinal products (e.g. quinidine, disopyramide or pimozide etc.)
- Volunteers with any rash or broken skin on the arm where the capsaicin will be applied
- Volunteers with lactose intolerance, as the placebo and ivabradine tablets contain lactose
- Volunteers with a resting heart rate of 59 beats per minute or less at screening
- Volunteers who are pregnant or breast feeding
- Female volunteers of childbearing potential who refuse to use hormonal contraceptive measures for the duration of the trial as listed in section 11.5 of the protocol
- Male volunteers who refuse to use adequate contraceptive measures for the duration of the trial as listed in section 11.5 of the protocol
- Volunteers who have an underlying medical condition such as migraine or epilepsy which may affect the trial findings
- Volunteers who smoke (=5 cigarettes/day), take recreational drugs or consume more than the recommended allowance of alcohol units per week (21 units per week for males and 14 units per week for females)
- Participants who are not willing to abstain from drinking beverages containing quinine, caffeine and/or xanthine for 24 hours prior to the trial visit
- Volunteers who produce a positive result in a urine screen for drugs of abuse or who are known or suspected to be drug-dependent (sedatives, hypnotics, tranquilizers or any other addictive agent)
- Volunteers who produce a positive result in an alcohol breath test
- Volunteers currently participating in any interventional trial, have participated in an interventional trial within 16 weeks of screening or are currently participating in a non-interventional trial which participating in this trial would impact upon
- Volunteers who, in the opinion of the PI, have a clinically relevant abnormality or medical history that is deemed to make the participant ineligible because of a safety concern.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified