A Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect After Single Dose Administration of JNJ-54861911 Tablet in Healthy Elderly Participants
An Open-Label, Randomized, Three-Period Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect of JNJ-54861911 Tablet (1x25mg) After Single Dose Administration in Healthy Elderly Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
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Merksem, Belgium
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must have a body mass index (BMI) between 18 and 30 Kilogram (kg)/Meter (m)^2, inclusive (BMI = weight/height^2)
- Participant must be healthy for their age group with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening and admission. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable
- Participants must be healthy on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel [including liver enzymes], hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Before randomization, a woman must be not of childbearing potential: postmenopausal (greater than or equal to [≥] 55 years of age with amenorrhea for at least 12 months; permanently sterilized [e.g., tubal occlusion, hysterectomy, bilateral salpingectomy]); or otherwise be incapable of pregnancy. In case of questionable status qualified personal of the sponsor should be consulted to decide on the potential for inclusion of the participant
- Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 90 days after receiving the last dose of study drug. In addition, their female partners should also use an appropriate method of birth control for at least the same duration. Effective methods of contraception include prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch
Exclusion Criteria:
- Participant has clinically significant abnormal findings in physical exam, vital signs or 12-lead ECG incl. QTcF greater than (>) 450 milliseconds (ms) for males and females, Left Bundle Branch Block, Atrioventricular (AV) Block second degree or higher, permanent pacemaker or implantable cardioverter defibrillator (ICD) at Screening or admission, which in the opinion of the investigator are not appropriate and reasonable for the population under study
- Participant has a history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
- Participant has a history of or current renal [Estimated glomerular filtration rate (eGFR) less than (<) 60 based on Modification of diet in renal diseases (MDRD) formula] or hepatic insufficiency
- Participant has a history of epilepsy or fits or unexplained black-outs other than vasovagal collapse
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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EXPERIMENTAL: Sequence 1 (ABC)
Participants will receive Treatment A (single dose of JNJ-54861911 25 milligram [mg] formulation 1 [reference] under fasted conditions) in Period 1; followed by Treatment B (single oral dose of JNJ-54861911 25 mg formulation 2 [test] under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg formulation 2 under fed conditions) in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
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Participants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.
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EXPERIMENTAL: Sequence 2 (ACB)
Participants will receive Treatment A in Period 1; followed by Treatment C in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
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Participants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.
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EXPERIMENTAL: Sequence 3 (BAC)
Participants will receive Treatment B in Period 1; followed by Treatment A in Period 2; followed by Treatment C in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
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Participants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.
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EXPERIMENTAL: Sequence 4 (BCA)
Participants will receive Treatment B in Period 1; followed by Treatment C in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
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Participants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.
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EXPERIMENTAL: Sequence 5 (CAB)
Participants will receive Treatment C in Period 1; followed by Treatment A in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
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Participants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.
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EXPERIMENTAL: Sequence 6 (CBA)
Participants will receive Treatment C in Period 1; followed by Treatment B in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
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Participants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Maximum Plasma Concentration (Cmax) of JNJ-54861911
Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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The Cmax is the maximum observed plasma concentration of JNJ-54861911.
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Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-54861911
Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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The Tmax is the time to reach the maximum observed plasma concentration of JNJ-54861911.
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Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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Area Under the Plasma Concentration-Time Curve From 0 to t Hours (AUC[0-t]) Post Dose of JNJ-54861911
Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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The AUC (0-t) calculated by trapezoidal summation [time t is the time of the last quantifiable concentration (C[last])].
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Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-54861911
Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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The AUC (0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.
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Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-54861911
Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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The AUC (0-infinity) is the area under the plasma JNJ-54861911concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-54861911 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
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Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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Elimination Rate Constant (Lambda [z]) of JNJ-54861911
Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
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Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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Terminal Half-life (t[1/2]) of JNJ-54861911
Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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The t(1/2) is defined as 0.693/Lambda (z).
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Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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Relative Bioavailability (F[rel]) of JNJ-54861911
Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect).
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Pre-dose; 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose on Day 1 of each period
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants with Adverse Events (AEs) and Serious AEs
Time Frame: Screening up to follow-up (7 to 14 days after last dose administration)
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Screening up to follow-up (7 to 14 days after last dose administration)
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- CR106621
- 2014-004251-31 (EUDRACT_NUMBER)
- 54861911ALZ1011 (OTHER: Janssen Research & Development, LLC)
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