A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants

Healthy Clinical Trial

Official title:

A Double-blind, Randomized, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-88260237 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05541315
• Other study ID #: CR109227
• Secondary ID: 88260237CKD1001
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2022
• Est. completion date: May 9, 2023

Study information

• Verified date: May 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• Otherwise, healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) evaluations performed at screening

• Body mass index (BMI) within the range 18 to 30 kilogram/meter^2 (kg/m^2) (inclusive)

• A female must be a) not of childbearing potential defined as postmenopausal or permanently sterile

• A female must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after administration of study intervention

• A male participant must agree not to donate sperm for the purpose of reproduction or plan to father a child during the study and for a minimum of 90 days after receiving study intervention

Exclusion Criteria:

• History of liver (with the exception of Gilbert's syndrome or asymptomatic gallstones) or renal insufficiency (estimated glomerular filtration rate [eGFR] below 90 mL/minute at screening only); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

• Any history of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin)

• Had major surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has any surgery planned during the time the participant is expected to participate in the study or within 4 weeks after study intervention administration

• History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed)

• Any current active infections, including localized infections, or any recent history (within 4 weeks prior to administration of study intervention) of active infections, or a history of recurrent, severe, or chronic infections, or otherwise increased risk of infection

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-88260237
JNJ-88260237 will be administered orally.
• Placebo
Matching placebo will be administered orally.

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs)	Number of participants with AEs will be reported.	Up to Day 14
Primary	Cohort 5: Number of Participants with Adverse Events (AEs)	Number of participants with AEs will be reported.	Up to Day 24
Primary	Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Vital Signs	Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.	Up to Day 7
Primary	Cohort 5: Number of Participants with Abnormalities in Vital Signs	Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.	Up to Day 21
Primary	Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG)	Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.	Up to Day 7
Primary	Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG)	Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.	Up to Day 21
Primary	Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters	Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.	Up to Day 7
Primary	Cohort 5: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters	Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.	Up to Day 21
Primary	Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations	Number of participants with abnormalities in physical examinations will be reported.	Up to Day 7
Primary	Cohort 5: Number of Participants with Abnormalities in Physical Examinations	Number of participants with abnormalities in physical examinations will be reported.	Up to Day 21
Secondary	Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237	Cmax is defined as the maximum whole blood concentration of JNJ-88260237.	Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Secondary	Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237	Tmax is defined as the time to reach the maximum whole blood concentration of JNJ-88260237.	Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Secondary	Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last]) of JNJ-88260237	AUC (0-Last) is defined as the area under the whole blood concentration versus time curve from time zero to time of the last measurable concentration of JNJ-88260237.	Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Secondary	Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237	AUC (0-infinity) is defined as the area under the whole blood concentration versus time curve from time zero to infinite time of JNJ-88260237.	Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Secondary	Terminal Half-life (T1/2) of JNJ-88260237	T1/2 is defined as the terminal half-life of JNJ-88260237.	Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Secondary	Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237	CL/F is defined as apparent oral whole blood clearance of JNJ-88260237.	Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Secondary	Apparent Volume of Distribution (Vz/F) of JNJ-88260237	Vz/F is defined as the apparent volume of distribution of JNJ-88260237.	Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21