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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: JNJ-40411813 100 mg

Drug: JNJ-40411813 50 mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01932333

2010-019404-22 (EudraCT Number)

40411813EDI1006 (Other Identifier)

CR017164

Details and patient eligibility

About

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.

Full description

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.

Enrollment

36 patients

Sex

All

Ages

65 to 85 years old

Volunteers

Accepts Healthy Volunteers

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