Status:
WITHDRAWN
A Study of JNJ-70075200 in Healthy Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate safety and tolerability of JNJ-70075200 compared with placebo after administration of single ascending doses of JNJ-70075200 as oral solution (Part 1); multiple...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant
- Participants be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
- No history of pathogen driven cancers (carcinomas, sarcomas, gastric cancer, bladder cancer,Cholangiocarcinoma)
- Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range 18 and 30 kilograms per square meter (kg/m\^2) (BMI = weight/height\^2) (inclusive)
- All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening
- Exclusion criteria:
- Participants having a history of liver or renal insufficiency (estimated creatinine clearance \[CL\] below 60 milliliter per minute \[mL/min\]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Participants having a QT interval corrected according to Fridericia's formula (QTcF) greater than (\>) 450 milliseconds (msec) for males, and \>470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at Day -1
- Known allergies, hypersensitivity, or intolerance to JNJ-70075200 or its excipients
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participants having a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day -2
Exclusion
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04782661
Start Date
March 1 2022
End Date
September 23 2022
Last Update
January 5 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands, 9728 NZ