A Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-54416076 in Healthy Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02670395
• Date of registration: 29/01/2016
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-54416076 in Healthy Participants
• Scientific title: A Double Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-54416076 in Healthy Male Subjects
• Date of first enrolment: April 2016
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02670395
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Body Mass Index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)
(inclusive) and body weight greater than or equal to (>=) 50 kg

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

- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140
millimeters of mercury (mmHg) systolic, inclusive, and between 50 and 90 mmHg
diastolic, inclusive

- Men must agree to use condoms (including men who have had vasectomies) 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 (example, prescription oral contraceptives,
contraceptive injections, intrauterine device, double barrier method, and
contraceptive patch) of contraception in addition to the condom used by the male study
participant

- 18 and 45 years of age, inclusive

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
(example, hyper/hypo-thyroidism), hematological disease (example, 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
phosphtase above the upper limit of normal of the clinical laboratory's reference
range at Screening or at Day -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, if participants have
hemoglobin, hematocrit, or red blood cell count below the lower limit of normal of the
clinical laboratory's reference range, the participants may be included if the
investigator judges that the abnormalities or deviations from the reference range are
not clinically significant

- History of cholecystectomy or gallbladder disease



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: JNJ-54416076

Drug: Placebo

Primary Outcome(s)

Maximum Observed Concentration (Cmax) [Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1]

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post-dose on Day 1]

Number of Participants with Adverse Events (AEs) and Serious AEs [Time Frame: Screening up to follow-up visit (7 to 10 days after last study procedure)]

Area Under the Concentration Versus Time Curve (AUC) From Time of Administration up to 24 Hours Post Dosing (AUC24h) [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post-dose on Day 1]

AUC From Time 0 to Infinite Time (AUC[0-infinity]) [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post-dose on Day 1]

Elimination Half-Life (t1/2) [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post-dose on Day 1]

Apparent Volume of Distribution (Vd/F) [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post-dose on Day 1]

Time To Reach The Maximum Observed Concentration (Tmax) [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post-dose on Day 1]

Total Clearance (CL/F) [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post-dose on Day 1]

Secondary ID(s)

2015-004162-29

54416076EDI1001

CR108105

Source(s) of Monetary Support

Please refer to primary and secondary sponsors