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Completed

NCT Number: NCT01932333

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

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.

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Key information

Conditions

Healthy

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Antwerp, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-40411813 50 mg

Drug

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

Drug

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

Drug

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.

Primary outcomes

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

    Time frame: 9 weeks

  2. Peak plasma concentration of JNJ 40411813

    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

    This sample will be used for pharmacokinetics analysis.

  3. Time to reach the peak plasma concentration of JNJ 40411813

    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

    This sample will be used for pharmacokinetics analysis.

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

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

  5. Elimination rate constant of JNJ 40411813

    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

    This sample will be used for pharmacokinetics analysis.

  6. Terminal half-life of JNJ 40411813

    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

    This sample will be used for pharmacokinetics analysis.

  7. Area under the plasma concentration of JNJ 40411813 - time curve from 0 to infinity post dosing

    Time frame: Both Cohorts, Period 1: Day 1 (predose to 12 hrs), Day 2 (24 and 36 hrs), Day 3, and Day 4

    This sample will be used for pharmacokinetics analysis.

  8. Predose plasma concentration of JNJ 40411813

    Time frame: 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

    This sample will be used for pharmacokinetics analysis.

  9. Average plasma concentration of JNJ 40411813 at steady state

    Time frame: 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

    This sample will be used for pharmacokinetics analysis.

  10. Cognitive test

    Time frame: Both Cohorts, Period 1: Screening; Both Cohorts, Period 2: Day -1 (1 day before study treatment) and Day 7

    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.

  11. Addiction Research Center Inventory questionnaire (ARCI-Q)

    Time frame: Both Cohorts, Period 1: Day -1 and Day 1 (3 hrs post dose); Both Cohorts, Period 2: Day 7

    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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 30, 2013
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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