Study to Investigate the Food Effect and Oral Bioavailability of Tablet Formulations Relative to Suspension Formulation of JNJ-54416076 in Healthy Participants

Healthy Clinical Trial

Official title:

An Exploratory Open-Label, Single Dose, Randomized, Three-Way Crossover Study In Healthy Subjects to Investigate the Food Effect and Oral Bioavailability of Tablet Formulations Relative to Suspension Formulation of JNJ-54416076

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02951845
• Other study ID #: CR108239
• Secondary ID: 54416076EDI1002
• Status: Withdrawn
• Phase: Phase 1
• First received: October 31, 2016
• Last updated: December 18, 2017
• Start date: November 22, 2016
• Est. completion date: February 17, 2017

Study information

• Verified date: December 2017
• 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 assess the oral bioavailability of the two tablet formulations of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a high fat meal on the pharmacokinetics of the tablet formulation in healthy participants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 17, 2017
• Est. primary completion date: February 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Before randomization, a woman must be: 1) Postmenopausal, defined as a) Greater than (>) 45 years of age with amenorrhea for greater than or equal to (>=)18 months, or b) > 45 years of age with amenorrhea for at least 6 months and lesser than (<)18 months and a serum follicle stimulating hormone (FSH) level >40 International units per liter (IU/L), or 2) Surgically sterile due to a hysterectomy, or bilateral oophorectomy, or bilateral tubal occlusion/ligation procedures, and 3) All women must have a negative serum pregnancy test at Screening; and on Day -1 at each treatment period

• Men (including those who have had vasectomies) must agree to use condoms even if their partner is pregnant (this is to ensure that the fetus is not exposed to the study drug through vaginal absorption) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Male participants should encourage their female partner to use an effective method (for example (eg), prescription oral contraceptives, contraceptive injections, intrauterine device, and contraceptive patch) of contraception in addition to the condom used by the male study participant

• Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiograms (ECGs) performed. If any of the results are abnormal, the participant may be included only if the investigator judges that the abnormalities or deviations from normal are not clinically significant except for liver function and hematology tests. This determination must be recorded in the participant's source documents and initialed by the investigator

• Body Mass Index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)(inclusive) and body weight >= 50 kilograms

• Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive at Screening and on Days -2 and -1 of Period 1. If blood pressure is out of range, up to 2 repeated assessments are permitted

Exclusion Criteria:

• History of, or currently active, significant illness or medical disorders, including (but not limited to) cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), endocrine or metabolic disease (eg, hyper/hypo-thyroidism), hematological disease (eg, von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders (including retinal disorders or cataracts), neoplastic disease, skin disorder, renal disorder, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

• History of Gilbert's disease, Dubin-Johnson or Rotor syndrome, or any family history of liver or gallbladder disease that may suggest an underlying genetic disorder

• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), bilirubin levels (indirect, or direct), or alkaline phosphatase above the upper limit of normal (ULN) of the clinical laboratory's reference range at Screening or at Day -1 of Period 1

• Hemoglobin, hematocrit, or red blood cell count below the lower limit of normal of the clinical laboratory's reference range at Screening. On Day -1 of Period 1, if participants have hemoglobin, hematocrit, or red blood cell count below the lower limit of normal of the laboratory's reference range, the participants may be included if the investigator judges that the abnormalities or deviations from the reference are not clinically significant

• History of cholecystectomy or gallbladder disease

• Known allergies, hypersensitivity, or intolerance to any of the excipients of the formulation

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-54416076 (Oral Suspension)
Participants will receive (25 mg) oral suspension of JNJ-54416076 in Part 1 and Part 2.
• JNJ-54416076 (Formulation 1: Direct Compression Tablets)
Participants will receive JNJ-54416076 Tablet formulation 1 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 1.
• JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)
Participants will receive JNJ-54416076 Tablet formulation 2 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 2.

Locations

Country	Name	City	State
n/a

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	Maximum Observed Analyte Concentration (Cmax)	Cmax is the maximum observed analyte concentration.	Predose up to Day 4
Primary	Time to Reach Maximum Concentration (Tmax)	Tmax is defined as actual sampling time to reach maximum observed analyte concentration.	Predose up to Day 4
Primary	Area Under Concentration Curve from time zero to the last quantifiable (AUC [0-last])	Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear trapezoidal summation.	Predose up to Day 4
Primary	Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity])	The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.	Predose up to Day 4
Primary	Apparent Terminal Elimination Half-life (t1/2term)	The elimination halflife (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda[z]).	Predose up to Day 4
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability		5 to 7 days after discharge (Follow-Up Phase )