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HealthyPhase 1NCT02260700

A Study to Evaluate Bioavailability, Food Effect, Safety and Tolerability of a Solid Dosage Formulation of JNJ-54861911 in Healthy Older Male 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 determine pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and the relative-bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-54861911 solid dosage formulation compared with JNJ 54861911… Read more about this study

Who is it for?
Ages 55 to 75 years, men onlyHealthy 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
Sep 2013to Nov 2013
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
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body mass index (BMI; weight [kilogram(kg)]/height^2 [meter square (m^2)]) between 18 and 30 kg/m^2, (inclusive)
  • 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 or admission. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable
  • 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 participants' source documents and initialed by the investigator
  • 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 for example, 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 3 months 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
  • Participants' must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Who cannot join

  • Participant has a clinically significant abnormal physical examination, vital signs or 12 lead ECG (including QTc greater than (>) 450msec, Left Bundle Branch Block, permanent pacemaker or implantable cardioverter defibrillator) at Screening or admission
  • Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Use of any prescription or over-the-counter medication, herbal medication, vitamins, or mineral supplements within 14 days prior to study drug administration (not including paracetamol). Medication for chronic use in age related disease will be allowed after approval by both the investigator and to the sponsor. No change in dose or regimen will be permitted during the study that is, from the Screening visit until the follow-up visit
  • Participant has a history of spontaneous, prolonged or severe bleeding of unclear origin
  • Participant has a history of epilepsy or fits or unexplained black-outs other than vasovagal collapse

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Study site

    Merksem

Other trials in Belgium

About this study

Official title: A Randomized, Open-Label, 3-Way Crossover Study in Healthy Older Male Subjects to Evaluate the Bioavailability, Food Effect, Safety and Tolerability of A Solid Dosage Formulation of JNJ-54861911

The purpose of this study is to determine pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and the relative-bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-54861911 solid dosage formulation compared with JNJ 54861911 oral suspension formulation in healthy older male 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), single-center, single-dose and 3-way Crossover (the same medications provided to all participants but in different sequence) study to determine the bioavailability of JNJ-54861911 solid dosage formulation in healthy older male participants. The study will consist of 3 parts: Screening Phase (that is, 28 days before study commences on Day 1), an open-label treatment Phase (consists of 3 single-dose treatment periods, either a single oral suspension formulation [Treatment A] or solid formulation 25 milligram (mg) dose of JNJ-54861911 under fasted [Treatment B] or fed conditions [Treatment C] in subsequent 3-treatment periods; each treatment period separated with washout period of 6 days) and follow-up Phase (7 to 14 days after last dose administration). The maximal study duration for a participant will not exceed 8 weeks. All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences. Followed by an overnight fast of at least 10 hours participants will be administered with study treatment under fasted condition or fed condition (30 minutes after high-fat, high-calorie 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. Bioavailability will be primarily evaluated by pharmacokinetic parameters. 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
Healthy, Bioavailability, Alzheimer's Disease, JNJ-54861911
Medical subject headings
Alzheimer Disease

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 dose of JNJ-54861911 as Treatment A (oral suspension formulation) under fasted conditions in one of the treatment periods.

  • JNJ-54861911 (Treatment B)Drug

    Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment B (solid formulation) under fasted conditions in one of the treatment periods.

  • JNJ-54861911 (Treatment C)Drug

    Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment C (solid formulation) under fed conditions in one of the treatment periods.

Study groups in NCT02260700
Study groupRoleWhat they receive
Sequence 1 (ABC)ExperimentalParticipants will receive Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 1; followed by Treatment B (single oral dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 3. A washout period of at least 6 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 (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 1; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 2; followed by Treatment B (single oral dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 3. A washout period of at least 6 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 (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 1; followed by Treatment A (single oral dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 3. A washout period of at least 6 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 (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 1; followed byTreatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 2; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 3. A washout period of at least 6 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 (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 1; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 2; followed by Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 3. A washout period of at least 6 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 (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 1; followed by Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 2; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 3. A washout period of at least 6 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; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 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; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 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; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period

  4. 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; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period

  5. 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; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period

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

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

    Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period

  7. 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; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period

  8. Rate of Absorption of JNJ-54861911

    Rate of absorption will be measured using the peak concentration of JNJ-54861911 (following administration of solid dosage form and suspension dosage form) under fasted conditions and fed conditions.

    Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period

  9. Extent of Absorption of JNJ-54861911

    Extent of absorption will be measured under fasted conditions and fed conditions, using the area under plasma concentrations of JNJ-54861911 versus time from time 0 to the last sample point (AUC[0-t]) and from time 0 to infinity (AUC[0-inf]).

    Measured: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 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 posted9 Oct 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionNov 2013
  4. Study completionNov 2013

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
NCT02260700
Sponsor's protocol ID
CR102380
Other IDs
54861911ALZ1003, 2013-002650-70
Status last verified
Oct 2014
First submitted
6 Oct 2014
Last updated
9 Oct 2014
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 9 Oct 2014. 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; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period). The study lists 9 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 NCT02260700.

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 9 Oct 2014.

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