Status:
COMPLETED
A Study in Healthy Volunteers to Assess the Effect of Different Types of Food on a Single-dose of JNJ-64417184 Administered as Tablets
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of 5 different food conditions on the single dose pharmacokinetics (PK) of the JNJ-64417184 tablet formulation administered orally, using the PK aft...
Eligibility Criteria
Inclusion
- Must have a body mass index (BMI); weight per height square between 18.0 and 30.0 kilogram per meter square (kg/m\^2), (extremes included), and body weight not less than 50.0 kg at screening
- Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Must have a normal 12-lead electrocardiogram (ECG) (triplicate) at screening, including: normal sinus rhythm (heart rate between 45 and 100 beats per minute \[bpm\], extremes included); QT interval corrected for heart rate (QTc); QRS interval less than (\<) 120 milliseconds (ms); PR interval less than or equals to \<= 200 ms. If the results of the ECG are outside the normal ranges, the subject may be included only if the investigator judges the deviations from normal ECG to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator
- Female participant must have a negative highly sensitive serum beta human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and on Days -1 for each treatment period (except for postmenopausal female participants)
- Must not use nicotine-containing substances including tobacco products (example, cigarettes, e-cigarettes, cigars, chewing tobacco, gum, or patch) for at least 3 months prior to screening
Exclusion
- Any evidence of heart block or bundle branch block at screening
- Current human immunodeficiency virus (HIV)-type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
- History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or HBV infection (confirmed by hepatitis B surface antigen), or HCV infection (confirmed by HCV antibody) at screening
- A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
- Has previously been dosed with JNJ-64417184
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04121052
Start Date
October 8 2019
End Date
December 23 2019
Last Update
January 28 2020
Active Locations (1)
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1
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands, 9728 NZ