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HealthyPhase 1NCT02623491

Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Participants

A Phase 1 study testing JNJ-55375515 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 safety, tolerability, and pharmacokinetics of JNJ-55375515 in healthy participants after administration of single and multiple oral doses. Read more about this study

Who is it for?
Ages 18 to 58 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-55375515
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
1 siteBelgium
Study dates
Nov 2015to Sep 2016
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 18 to 58 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant must be healthy on the basis of physical and neurological examination, medical history, vital signs, and electrocardiogram (ECG), and have a body mass index of 18-30 kilogram / square meter (kg/m^2) and a body mass of not less than 50 kg.
  • Participant must be healthy on the basis of clinical laboratory tests performed at Screening and Day -1.
  • Female participants must not be of childbearing potential by either being post-menopausal or permanently sterilized.
  • Female participants must not be pregnant.
  • Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, including contraception.
  • Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and are willing to participate in the study.

Who cannot join

  • Participant has current, or history of, clinically significant medical or psychiatric illness.
  • Participant has any condition for which participation would not be in the best interest of the participant or that could prevent, limit, or confound any protocol specified assessments or the interpretation of the study results.
  • Participant has a personal history of, or a first degree relative with a history of, acute angle-closure glaucoma, or participant has significant hyperopia (far-sightedness).
  • Participant has a QT corrected according to Fridericia's formula (QTcF) interval greater than (>) 450 msec (male) or >470 msec (female), or has a history of additional risk factors for torsades de pointes.
  • Participant has history of vasovagal episodes.
  • Participant has history of drug, alcohol, nicotine, or caffeine abuse.
Show all 12Show fewer
  • Participant who is breastfeeding.
  • Participant has had major surgery within 12 weeks of Screening, has donated more than 450 milliliters (mL) of blood, or has acute loss of equivalent amount of blood within 90 days of study drug administration.
  • Participant has positive fecal occult blood test results at Screening.
  • Participant has history of clinically significant drug and/or food allergies.
  • Participant has received another investigational drug within 1 month or a period of less than 10 times the drug's half-life, whichever is longer, before the planned first dose of study drug
  • Participant is an employee, or family member of an employee, of the study site.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Study site

    Merksem

Other trials in Belgium

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Subjects

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-55375515 in healthy participants after administration of single and multiple oral doses.

Read the detailed description

This is a randomized (study medication assigned to participants by chance), double-blind (neither the investigator nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive comparator treatment that has no study drug in it), single center study in healthy male participants and female participants of non-childbearing potential (surgically sterile or post menopausal), aged 18 to 58 years inclusive. This study will consist of two parts; a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part. The SAD will consist of 6 escalating dose cohorts. Participants in each cohort will be randomized to receive a single oral administration of JNJ-55375515 or placebo after an overnight fast. The planned doses of JNJ-55375515 range from 0.75 to 100 milligrams (mg). Participants in an additional cohort will be dosed in the fed state to determine the effects of food on the safety, tolerability and pharmacokinetics of JNJ-55375515. An additional optional cohort may be evaluated to further explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-55375515, with the maximal dose not exceeding 200 mg. The study duration for participants in the SAD part of the study will be approximately 2 to 5.5 weeks, including eligibility Screening. The MAD will consist of 3 cohorts of 9 participants. Participants will receive once daily oral doses of JNJ-55375515 or placebo for 10 consecutive days. The study duration for participants in the MAD part of this study will be approximately 3 to 7 weeks including the eligibility Screening. The Safety of Participants will be monitored throughout the study.

Conditions
Healthy
Being tested
JNJ-55375515, Placebo
Keywords
JNJ-55375515, Healthy, Placebo

What participants receive

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

  • JNJ-55375515Drug

    Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.

  • PlaceboDrug

    Participants will receive matching placebo.

Study groups in NCT02623491
Study groupRoleWhat they receive
Part 1: Single Ascending Dose (SAD)ExperimentalParticipants will receive 0.75 milligrams (mg) of JNJ-55375515 (starting dose) or Placebo on Day 1. Dose of the study medication will be escalated sequentially up to a maximum of 200 mg.
Receives: Drug: JNJ-55375515; Drug: Placebo
Part 2: Multiple Ascending Dose (MAD)ExperimentalParticipants will receive JNJ-55375515 (at doses determined based on the data from the SAD part) or Placebo from Day 1 to 10.
Receives: Drug: JNJ-55375515; Drug: Placebo

What is being measured

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

  1. Number of Participants with Adverse Events

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Up to Day 7 after discharge

  2. Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    The Tmax is defined as actual sampling time to reach maximum observed concentration.

    Measured: Up to Day 5

  3. Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])

    The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.

    Measured: Up to Day 5

  4. Part 1: Elimination Half-Life (t1/2)

    The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

    Measured: Up to Day 5

  5. Part 1: Maximum Observed Plasma Concentration (Cmax)

    The Cmax is the maximum observed concentration.

    Measured: Up to Day 5

  6. Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    The Tmax is defined as actual sampling time to reach maximum observed concentration.

    Measured: Up to Day 15

  7. Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])

    The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.

    Measured: Up to Day 15

  8. Part 2: Elimination Half-Life (t1/2)

    The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

    Measured: Up to Day 15

  9. Part 2: Maximum Observed Plasma Concentration (Cmax)

    The Cmax is the maximum observed concentration.

    Measured: Up to Day 15

Secondary outcomes (6)

  1. Maximum Tolerated Dose (MTD) of JNJ-55375515

    The maximum tolerated dose is defined as the dose below the dose at which 2 or more subjects receiving the same dose of active study drug experience the same dose-limiting toxicity or have the same severe adverse event, or below the level at which the Investigator and Sponsor agree that an unacceptable dose-limiting toxicity has occurred in a single subject treated with active study drug.

    Measured: Up to Day 5 in part 1; up to Day 15 in part 2

  2. Part 1: The Effect of Food on the Number of Adverse Events

    Measured: Baseline up to Day 5

  3. Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Tmax)

    Measured: Baseline up to Day 5

  4. Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Cmax)

    Measured: Baseline up to Day 5

  5. Part 1: The Effect of Food on Elimination Half-Life (t1/2)

    Measured: Baseline up to Day 5

  6. Part 1: The Effect of Food on Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])

    Measured: Baseline up to Day 5

Timeline

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

  1. First posted7 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionSep 2016
  4. Study completionSep 2016

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
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02623491
Sponsor's protocol ID
CR108063
Other IDs
2015-003817-31, 55375515EDI1001, 2015
Status last verified
Dec 2016
First submitted
18 Nov 2015
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-55375515 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 6 inclusion and 12 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 6 Dec 2016. 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?

Number of Participants with Adverse Events (time frame: Up to Day 7 after discharge). 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 NCT02623491.

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 6 Dec 2016.

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