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

Healthy Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-40411813 in Male and Female Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932333
• Other study ID #: CR017164
• Secondary ID: 40411813EDI10062
• Status: Completed
• Phase: Phase 1
• First received: August 27, 2013
• Last updated: August 27, 2013
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: August 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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).
• 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).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1 and Cohort 2: Number of participants with adverse events		9 weeks	Yes
Primary	Peak plasma concentration of JNJ 40411813	This sample will be used for pharmacokinetics analysis.	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	No
Primary	Time to reach the peak plasma concentration of JNJ 40411813	This sample will be used for pharmacokinetics analysis.	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	No
Primary	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.	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	No
Primary	Elimination rate constant of JNJ 40411813	This sample will be used for pharmacokinetics analysis.	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	No
Primary	Terminal half-life of JNJ 40411813	This sample will be used for pharmacokinetics analysis.	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	No
Primary	Area under the plasma concentration of JNJ 40411813 - time curve from 0 to infinity post dosing	This sample will be used for pharmacokinetics analysis.	Both Cohorts, Period 1: Day 1 (predose to 12 hrs), Day 2 (24 and 36 hrs), Day 3, and Day 4	No
Primary	Predose plasma concentration of JNJ 40411813	This sample will be used for pharmacokinetics analysis.	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	No
Primary	Average plasma concentration of JNJ 40411813 at steady state	This sample will be used for pharmacokinetics analysis.	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	No
Primary	Cognitive test	This test will be used for pharmacodynamics analysis. Cognitive test is a group of mental processes that includes attention, memory, producing and understanding language, learning, reasoning, problem solving, and decision making. It is assess by word presentation, immediate word recall, picture presentation, simple reaction time, digit vigilance, choice reaction time, spatial working memory, numeric working memory, delayed word recall, word recognition, and picture recognition. It refers to an information processing view of a participant's psychological functions.	Both Cohorts, Period 1: Screening; Both Cohorts, Period 2: Day -1 (1 day before study treatment) and Day 7	No
Primary	Addiction Research Center Inventory questionnaire (ARCI-Q)	This questionnaire will be used for pharmacodynamics analysis. The ARCI-Q is a 49-item questionnaire that probes subjective feeling induced by a drug and categorizes them in four classes of drugs of abuse (morphine-like opioids, alcohol, stimulants and hallucinogens). This test is a self-rating scale. Only 'True (positive)' responses are scored. One point is given for each true response in items. The final score is the sum of the total 'true' responses. Lower scores indicate worsening.	Both Cohorts, Period 1: Day -1 and Day 1 (3 hrs post dose); Both Cohorts, Period 2: Day 7	No