Drug interaction study of ONO-4641 with atenolol or diltiazem
Research type
Research Study
Full title
A Phase I, Single-Center, Double-Blind, Randomized, Cross-Over Trial on the Cardiovascular Effects of Ceralifimod (ONO-4641) Given in Combination with Steady State Atenolol or Diltiazem in Healthy Subjects
IRAS ID
151967
Contact name
Saeed Khan
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2014-000249-57
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
ONO-4641 is an immunosuppressive drug that is currently developed for the treatment of Multiple Sclerosis.
This will NOT be the first time this drug has been given to human volunteers.
Multiple sclerosis (MS) is a disease affecting nerves, brain and spinal cord, causing problems with muscle movement, balance and vision. ONO-4641 works on body’s immune system to reduce the damage to the nerves and brain in MS. This mechanism of action of ONO-4641 also suppresses the body’s defence against infections.
It has been observed in clinical trials that ONO-4641 can cause the heart rate to slow down, especially after taking the first dose.
Atenolol and Diltiazem are licensed anti-hypertensive medications which have been used for many years to treat hypertension and heart diseases (such as heart rhythm disorders, angina and heart attacks). These medications can also cause the heart to slow down. The purpose of this trial is to study the effect of ONO-4641 when given in combination with Atenolol or Dilitiazem.
This study consists of part A and B. Volunteers will participate in only one part.
In Part A volunteers will participate in two residential periods at least 12 days apart receiving Atenolol (Treatment A) or Placebo (Treatment B) once daily by mouth on Days 1-6 and ONO-4641 on Days 5 and 6.
In Part B volunteers will participate in two residential periods at least 12 days apart will receive Diltiazem (Treatment C) or Placebo (Treatment D) twice daily by mouth on Days 1-6 and ONO-4641 on Days 5 and 6.REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0154
Date of REC Opinion
1 May 2014
REC opinion
Further Information Favourable Opinion