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

Phase 1CompletedNCT01932333

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.36 enrolled

Overview

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.

This is a double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), single- and multiple ascending dose study. This study consists of 3 phases: screening phase, treatment phase, and follow-up phase. This study will be conducted in 2 cohorts (groups) (Cohort 1: JNJ-40411813 50 mg and Cohort 2: JNJ-40411813 100 mg) and each cohort consists of 2 periods (Period 1: single dose and Period 2: multiple doses). Approximately 36 participants will be enrolled in this study (18 participants will be enrolled in each cohort) to receive JNJ-40411813 or placebo in 2:1 ratio. If safety/tolerability and pharmacokinetic results profile is favorable for single dose of JNJ-40411813, multiple dose administration will follow. Safety will be evaluated by the assessment of adverse events, vital signs, schellong test (a test for circulatory function), 12-lead electrocardiogram, physical examination, neurological examination (to measure mental status, motor examination, reflexes, sensory, gait and cranial nerves), vertigo (giddiness) symptom, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for a participant will be 9 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

JNJ-40411813 50 mgDRUG

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).

JNJ-40411813 100 mgDRUG

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).

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female participants must be postmenopausal for at least 12 months * Body mass index (BMI) between 18 and 33 kg/m2 (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\]) Exclusion Criteria: * Clinically significant abnormal values for laboratory tests and abnormal physical examination * Significant history of or current significant unstable medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea (difficulty in breathing), diabetes mellitus, thyroid disease, infection * Significant history of or current psychiatric or neurological illness * Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies at screening * Positive urine screen for drugs of abuse and positive alcohol breath test at screening or administration of the study medication * Only the use of any prescription medication that is known to be potent CYP3A4 inhibitors or inducers within 2 weeks of start of study medication

Locations (1)

Unnamed facility

Antwerp, Belgium

Outcomes

Primary Outcomes

Cohort 1 and Cohort 2: Number of participants with adverse events

Time frame: 9 weeks

Peak plasma concentration of JNJ 40411813

This sample will be used for pharmacokinetics analysis.

Time frame: Both Cohorts, Period 1: Day 1 (predose to 12 hrs), Day 2 (24 and 36 hrs), Day 3, and Day 4; Both Cohorts, Period 2: Day 1 (predose to 12 hrs); predose on Days 2, 3, 4, 5, 6, 7, 8, 9; Day 10 (predose to 12 hrs); Day 11 (0 and 12 hrs); Days 12, 13, and 14

Time to reach the peak plasma concentration of JNJ 40411813

This sample will be used for pharmacokinetics analysis.

Area under the plasma concentration of JNJ 40411813 - time curve from 0 to t hours post dosing

Time 't' is the time of the last quantifiable concentration of JNJ-40411813. This sample will be used for pharmacokinetics analysis.

Elimination rate constant of JNJ 40411813

This sample will be used for pharmacokinetics analysis.

Terminal half-life of JNJ 40411813

This sample will be used for pharmacokinetics analysis.

Data from ClinicalTrials.gov

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