MedTrace Logo

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-40411813 in Male and Female Elderly Patients

NCT01932333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-08-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the study medication) and pharmacodynamics (the study of the action or effects the study medication has on the body) of single- and multiple, escalating oral doses of JNJ-40411813.

Conditions

  • Healthy

Interventions

DRUG

JNJ-40411813 50 mg

Cohort 1: Participants will receive 50 mg of JNJ-40411813 (2 capsules X 25 mg) once a day on Day 1 in Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 in Period 2 orally (by mouth).

DRUG

JNJ-40411813 100 mg

Cohort 2: Participants will receive 100 mg of JNJ-40411813 (1 capsule X 100 mg) once a day on Day 1 in Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 in Period 2 orally (by mouth).

DRUG

Placebo

Cohort 1: Participants will receive placebo once a day on Day 1 for Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 for Period 2; Cohort 2: Participants will receive placebo once a day on Day 1 for Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 for Period 2.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01932333 on ClinicalTrials.gov