Safety, tolerability & PK of JNJ-63623872 in healthy Japanese subjects
Research type
Research Study
Full title
A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-63623872 in Healthy Japanese Adult Subjects
IRAS ID
178411
Contact name
Annelize Koch
Contact email
Sponsor organisation
Janssen Cilag B.V.
Eudract number
2015-000247-16
Duration of Study in the UK
0 years, 1 months, 22 days
Research summary
The new medicine tested in this study is a compound called JNJ-63623872. The Sponsor is developing this study drug for treating influenza A virus (flu). Flu is an acute (fast onset and short duration) viral infection that has a number of symptoms including: fever, headache, tiredness, coughing, muscle pains and a sore throat.
The study drug interferes with a process that the influenza A virus uses to survive and multiply in the body.
The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing in Japanese adults; this is done by finding out if the study drug causes side effects (unexpected or unwanted reactions from taking a drug). The study will also investigate how long the study drug stays in and acts on the body, by looking at how the study drug is taken up (absorbed), metabolised (chemically broken down), distributed throughout the body and excreted (removed from the body).
This study will recruit healthy, non-smoking, Japanese males and females between the ages of 20 and 55 years. A total of approximately 24 subjects will take part in the study.
The study duration is approximately 6 weeks, consisting of a screening visit, treatment period and follow-up visit.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic analysis will be collected.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0120
Date of REC Opinion
15 Apr 2015
REC opinion
Favourable Opinion