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HealthyPhase 1NCT02355561

A Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect After Single Dose Administration of JNJ-54861911 Tablet in Healthy Elderly Participants

A Phase 1 study testing JNJ-54861911 (Treatment A), JNJ-54861911 (Treatment B) and JNJ-54861911 (Treatment C) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the effect of a high-fat/high-caloric breakfast on the rate and extent of absorption of the single oral dose of 25 mg JNJ-54861911 test formulation in healthy elderly participants. Read more about this study

Who is it for?
Ages 55 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-54861911 (Treatment A), JNJ-54861911 (Treatment B) and JNJ-54861911 (Treatment C)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteBelgium
Study dates
Jan 2015to Mar 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Study site

    Merksem

Other trials in Belgium

About this study

Official title: 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

The purpose of this study is to assess the effect of a high-fat/high-caloric breakfast on the rate and extent of absorption of the single oral dose of 25 mg JNJ-54861911 test formulation in healthy elderly participants.

Read the detailed description

This is a randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), 3-treatment, 3-period, 6-sequence crossover (participants may receive different interventions sequentially during the trial), and single-center study of JNJ-54861911. The duration of study will be approximately of 7 weeks per participant. The study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1); Open-label Treatment (consists of 3 single-dose treatments, either JNJ-54861911 formulation 1 [reference] or JNJ-54861911 formulation 2 [test] under fed or fasted condition), in subsequent 3-treatment periods, each separated with washout period of 7 days); and End-of-Study (up-to 14 days after last study drug administration). All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences. In fasted conditions, study drug will be administered following a 10-hour overnight fast. In fed conditions, participants will also fast from food for 10 hours, but will consume a high fat/high calorie breakfast within a 30-minute period. Study drug will be administered 30 minutes after the start of breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of two formulations of JNJ-54861911 (test and reference) will be evaluated primarily. Participants' safety will be monitored throughout the study.

Conditions
Healthy
Being tested
JNJ-54861911 (Treatment A), JNJ-54861911 (Treatment B), JNJ-54861911 (Treatment C)
Keywords
Bioavailability, Healthy Participants, JNJ-54861911, Food Effect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-54861911 (Treatment A)Drug

    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.

  • JNJ-54861911 (Treatment B)Drug

    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.

  • JNJ-54861911 (Treatment C)Drug

    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.

Study groups in NCT02355561
Study groupRoleWhat they receive
Sequence 1 (ABC)ExperimentalParticipants 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.
Receives: Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)
Sequence 2 (ACB)ExperimentalParticipants 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.
Receives: Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)
Sequence 3 (BAC)ExperimentalParticipants 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.
Receives: Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)
Sequence 4 (BCA)ExperimentalParticipants 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.
Receives: Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)
Sequence 5 (CAB)ExperimentalParticipants 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.
Receives: Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)
Sequence 6 (CBA)ExperimentalParticipants 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.
Receives: Drug: JNJ-54861911 (Treatment A); Drug: JNJ-54861911 (Treatment B); Drug: JNJ-54861911 (Treatment C)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Plasma Concentration (Cmax) of JNJ-54861911

    The Cmax is the maximum observed plasma concentration of JNJ-54861911.

    Measured: 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

  2. Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-54861911

    The Tmax is the time to reach the maximum observed plasma concentration of JNJ-54861911.

    Measured: 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

  3. Area Under the Plasma Concentration-Time Curve From 0 to t Hours (AUC[0-t]) Post Dose of JNJ-54861911

    The AUC (0-t) calculated by trapezoidal summation [time t is the time of the last quantifiable concentration (C[last])].

    Measured: 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

  4. Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-54861911

    The AUC (0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.

    Measured: 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

  5. Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-54861911

    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.

    Measured: 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

  6. Elimination Rate Constant (Lambda [z]) of JNJ-54861911

    The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.

    Measured: 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

  7. Terminal Half-life (t[1/2]) of JNJ-54861911

    The t(1/2) is defined as 0.693/Lambda (z).

    Measured: 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

  8. Relative Bioavailability (F[rel]) of JNJ-54861911

    Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect).

    Measured: 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

Secondary outcomes (1)

  1. Number of Participants with Adverse Events (AEs) and Serious AEs

    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.

    Measured: Screening up to follow-up (7 to 14 days after last dose administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02355561
Sponsor's protocol ID
CR106621
Other IDs
2014-004251-31, 54861911ALZ1011, 2014
Status last verified
Mar 2017
First submitted
30 Jan 2015
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-54861911 (Treatment A), JNJ-54861911 (Treatment B) and JNJ-54861911 (Treatment C) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02355561.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.

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Clinical Trial NCT02355561 | AzTrials