Clinical trial NCT04782661: A Study of JNJ-70075200 in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-70075200 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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 ascending doses of JNJ-70075200, administered as oral solution over 14 consecutive days (Part 2); and the option of a single dose of JNJ-70075200 administered as an oral solid formulation (Part 3).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 1 year and 1 month
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 1 year and 1 month
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to 1 year and 1 month
measure: Number of Participants with Clinically Significant Changes in Physical Examination
timeFrame: Up to 1 year and 1 month
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Up to 1 year and 1 month
measure: Change From Baseline in QTc Interval
timeFrame: Baseline, up to 1 year and 1 month
measure: Change from Baseline in Heart Rate (HR)
timeFrame: Baseline, up to 1 year and 1 month
measure: Change from Baseline in QRS Interval
timeFrame: Baseline, up to 1 year and 1 month
measure: Change from Baseline in PR Interval
timeFrame: Baseline, up to 1 year and 1 month
measure: Change From Baseline in QT Interval
timeFrame: Baseline, up to 1 year and 1 month
Secondary outcomes:
measure: Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time
timeFrame: Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15)
measure: Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect)
timeFrame: Predose, up to 72 hours postdose (up to Day 4)
measure: Part 1 and 3: Percentage of Participants with TEAEs (Food Effect)
timeFrame: Up to 1 year and 1 month
measure: Part 1 and 3: Percentage of Participants with SAEs (Food Effect)
timeFrame: Up to 1 year and 1 month
measure: Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect)
timeFrame: Up to 1 year and 1 month
measure: Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect)
timeFrame: Up to 1 year and 1 month
measure: Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect)
timeFrame: Up to 1 year and 1 month
measure: Part 1 and 3: Change From Baseline in QTc Interval (Food Effect)
timeFrame: Baseline, up to 1 year and 1 month
measure: Part 1 and Part 3: Change from Baseline in HR (Food Effect)
timeFrame: Baseline, up to 1 year and 1 month
measure: Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect)
timeFrame: Baseline, up to 1 year and 1 month
measure: Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect)
timeFrame: Baseline, up to 1 year and 1 month
measure: Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect)
timeFrame: Baseline, up to 1 year and 1 month
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trials
role: STUDY_DIRECTOR
References: