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

December 5, 2016 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Single Ascending Dose (SAD)
Participants 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.
Drug: JNJ-55375515
Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.
Drug: Placebo
Participants will receive matching placebo.
Experimental: Part 2: Multiple Ascending Dose (MAD)
Participants will receive JNJ-55375515 (at doses determined based on the data from the SAD part) or Placebo from Day 1 to 10.
Drug: JNJ-55375515
Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.
Drug: Placebo
Participants will receive matching placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: Up to Day 7 after discharge
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.
Up to Day 7 after discharge
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Up to Day 5
The Tmax is defined as actual sampling time to reach maximum observed concentration.
Up to Day 5
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
Time Frame: Up to Day 5
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
Up to Day 5
Part 1: Elimination Half-Life (t1/2)
Time Frame: Up to Day 5
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).
Up to Day 5
Part 1: Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to Day 5
The Cmax is the maximum observed concentration.
Up to Day 5
Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Up to Day 15
The Tmax is defined as actual sampling time to reach maximum observed concentration.
Up to Day 15
Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
Time Frame: Up to Day 15
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
Up to Day 15
Part 2: Elimination Half-Life (t1/2)
Time Frame: Up to Day 15
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).
Up to Day 15
Part 2: Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to Day 15
The Cmax is the maximum observed concentration.
Up to Day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD) of JNJ-55375515
Time Frame: Up to Day 5 in part 1; up to Day 15 in part 2
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.
Up to Day 5 in part 1; up to Day 15 in part 2
Part 1: The Effect of Food on the Number of Adverse Events
Time Frame: Baseline up to Day 5
Baseline up to Day 5
Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Tmax)
Time Frame: Baseline up to Day 5
Baseline up to Day 5
Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Cmax)
Time Frame: Baseline up to Day 5
Baseline up to Day 5
Part 1: The Effect of Food on Elimination Half-Life (t1/2)
Time Frame: Baseline up to Day 5
Baseline up to Day 5
Part 1: The Effect of Food on Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
Time Frame: Baseline up to Day 5
Baseline up to Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108063
  • 2015-003817-31 (EudraCT Number)
  • 55375515EDI1001 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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