NCT02670395

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

Completed Phase 1 Last updated 31 January 2025

What this trial tests

Phase 1 trial testing JNJ-54416076 in Healthy in 64 participants. Completed in 1 September 2016.

Timeline

1 April 2016

Primary endpoint
1 September 2016

1 September 2016

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	1 April 2016
Primary completion	1 September 2016
Estimated completion	1 September 2016
Sites	1 location across Germany

Drugs / interventions tested

• JNJ-54416076
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)
  An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent o
• 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
  Tmax is the actual sampling time to reach the maximum observed concentration.
• 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
  The AUC24h is the area under the concentration versus time curve (AUC) from time of administration up to 24 hours post dosing.
• 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
  The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
• 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
  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(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
• 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
  The elimination half-life (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 is calculated as 0.693/lambda(z).

Sponsor's own description

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of JNJ-54416076 and any associated metabolite(s) (in Part 1) and safety, tolerability and PK of JNJ-54416076 when co administered with food compared to administration in fasting condition (in Part 2).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.