A Double-Blind, Placebo-Controlled, Randomized, Single-Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-54861911 in Healthy Japanese Male Subjects

NCT02180269 Phase 1 COMPLETED

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK, study of the way a drug enters and leaves the blood and tissues over time) of single-ascending oral doses of JNJ-54861911 in healthy Japanese male participants.

Details

Lead sponsor	Janssen Pharmaceutical K.K.
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2014-06
Completion	2014-08

Conditions

• Healthy

Interventions

• JNJ-54861911 (25 mg)
• JNJ-54861911 (50 mg)
• JNJ-54861911 (100 mg)
• Placebo

Primary outcomes

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — Screening up to 14 days after last dose administration or early withdrawal
  An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose administration, that were absent before treatment or that worsened relative to pretreatment state.
• Maximum Plasma Concentration (Cmax) — Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1
  The Cmax is the maximum observed plasma concentration.
• Time to Reach Maximum Concentration (Tmax) — Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1
  The Tmax is time to reach the maximum observed plasma concentration.
• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) — Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1
  The AUC (0-last) is area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (Clast).
• Apparent Clearance (CL/F) — Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-administration of drug on Day 1
  Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Countries

Japan