A Study of JNJ-70075200 in Healthy Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04782661
• Other study ID #: CR108971
• Secondary ID: 2020-004946-1270
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 1, 2022
• Est. completion date: September 23, 2022

Study information

• Verified date: December 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 23, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-70075200
JNJ-70075200 solution or solid formulations will be administered orally.
• Placebo
Placebo solution will be administered orally.

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to 1 year and 1 month
Primary	Percentage of Participants with Serious Adverse Events (SAEs)	A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.	Up to 1 year and 1 month
Primary	Number of Participants with Clinically Significant Changes in Vital Signs	Number of participants with clinically significant changes in vital signs will be assessed.	Up to 1 year and 1 month
Primary	Number of Participants with Clinically Significant Changes in Physical Examination	Number of participants with clinically significant changes in physical examination will be assessed.	Up to 1 year and 1 month
Primary	Number of Participants With Clinically Significant Laboratory Abnormalities	Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.	Up to 1 year and 1 month
Primary	Change From Baseline in QTc Interval	Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG).	Baseline, up to 1 year and 1 month
Primary	Change from Baseline in Heart Rate (HR)	Change from baseline in HR will be measured by ECG.	Baseline, up to 1 year and 1 month
Primary	Change from Baseline in QRS Interval	Change from baseline in QRS interval will be measured by ECG.	Baseline, up to 1 year and 1 month
Primary	Change from Baseline in PR Interval	Change from baseline in PR interval will be measured by ECG.	Baseline, up to 1 year and 1 month
Primary	Change From Baseline in QT Interval	Change from baseline in QT interval will be measured by ECG.	Baseline, up to 1 year and 1 month
Secondary	Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time	Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).	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)
Secondary	Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect)	Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive LC-MS/MS.	Predose, up to 72 hours postdose (up to Day 4)
Secondary	Part 1 and 3: Percentage of Participants with TEAEs (Food Effect)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to 1 year and 1 month
Secondary	Part 1 and 3: Percentage of Participants with SAEs (Food Effect)	A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.	Up to 1 year and 1 month
Secondary	Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect)	Number of participants with clinically significant changes in vital signs will be assessed.	Up to 1 year and 1 month
Secondary	Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect)	Number of participants with clinically significant changes in physical examination will be assessed.	Up to 1 year and 1 month
Secondary	Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect)	Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.	Up to 1 year and 1 month
Secondary	Part 1 and 3: Change From Baseline in QTc Interval (Food Effect)	Change from baseline in QTc interval using Fridericia method will be measured by ECG.	Baseline, up to 1 year and 1 month
Secondary	Part 1 and Part 3: Change from Baseline in HR (Food Effect)	Change from baseline in HR will be measured by ECG.	Baseline, up to 1 year and 1 month
Secondary	Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect)	Change from baseline in QRS interval will be measured by ECG.	Baseline, up to 1 year and 1 month
Secondary	Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect)	Change from baseline in PR interval will be measured by ECG.	Baseline, up to 1 year and 1 month
Secondary	Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect)	Change from baseline in QT interval will be measured by ECG.	Baseline, up to 1 year and 1 month