Status:
COMPLETED
A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to evaluate the effect of multiple-dose administration of lansoprazole on the single-dose pharmacokinetics (PK) of JNJ-64417184 in healthy adult participants; and ...
Eligibility Criteria
Inclusion
- Must have a body mass index (BMI) between 18.0 and 30.0 kilograms per square meters \[kg/m\^2\]), extremes included, and body weight not less than 50.0 kilograms (kg) at screening
- Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening
- Healthy on the basis of clinical laboratory tests performed at screening
- 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) according to Fridericia (QTcF) less than or equal to (\<=) 450 milliseconds (ms) for male participants and \<= 470 ms for female participants; QRS interval less than (\<) 120 ms; PR interval \<= 200 ms. If the results of the ECG are outside the normal ranges, the participant 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 participant's source documents and initialed by the investigator
- Must sign an informed consent form (ICF) indicating he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities
Exclusion
- History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR) \<60 milliliter per minute (mL/min) at screening, calculated by the Modification of Diet in Renal Disease \[MDRD\] formula), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
- Past history of clinically significant cardiac arrhythmias (for example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
- Any evidence of clinically significant heart block or bundle branch block at screening
- Current human immunodeficiency virus 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 hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or HCV infection (confirmed by hepatitis C virus \[HCV\] antibody) at screening
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04453189
Start Date
July 20 2020
End Date
September 14 2020
Last Update
February 3 2025
Active Locations (1)
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1
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands, 9728 NZ