A First-in-Human Study of JNJ-28431754 in Healthy Male Volunteers

August 10, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A First-in-Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Escalating Oral Doses of JNJ 28431754 in Healthy Male Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and or the pharmacodynamics (PD) of single oral doses of JNJ-28431754 in healthy male volunteers. The study will evaluate the PK and PD effects of study drug in volunteers who fasted compared to those who did not fast before study drug administration.

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 single-center study that will be conducted in two Parts (Part 1 and Part 2). Volunteers may participate in Part 1 or Part 2 of the study but not in both Part 1 and Part 2. Part 1 of the study will evaluate the safety and tolerability of single, oral (by mouth) escalating (increasing) doses of JNJ 28431754 (ranging from 10 mg to 600 mg) or placebo in healthy male volunteers. The pharmacokinetics (PK), how JNJ 28431754 is absorbed, distributed, and removed from the body over time and pharmacodynamics (PD), the effects JNJ-28431754 has on the body, will also be evaluated. Part 2 of the study is a randomized, 2 period crossover study where 8 eligible male volunteers will receive a single oral dose of JNJ 28431754 on 2 occasions (14 days apart) with and without food (ie, a standard meal) to assess the effect of co-administration with food on the PK and PD of JNJ-28431754. In Part 1, at least 48 healthy male volunteers who meet entry criteria will be randomized (assigned by chance) into 6 cohorts (dose groups) and receive a single oral dose of study drug (JNJ-28431754 or placebo); study drug will be assigned to volunteers double-blinded (neither the investigator or the volunteer will know the identity of the assigned treatment). One or more additional cohorts may be added to the study; the additional cohort may test a previously tested dose of JNJ 28431754 as 2 equally divided doses, to be administered 10 hours apart. Each volunteer will participate in one dose group only. Each dose group will evaluate a different dose strength of JNJ-28431754 (10 mg to 600 mg) starting at the lowest dose. Volunteers in each dose group will be required to stay overnight in the clinical research unit (CRU) for 6 nights to receive study drug and to have safety, tolerability, PK, and PD assessments performed. Patients will return to the CRU for a final safety follow-up visit 10 to 14 days after study drug administration. For each volunteer, the total duration of Part 1 of the study will be at least 5 weeks (includes a 3-week screening period). In Part 2 of the study, 8 eligible male volunteers will receive a single oral dose of JNJ 28431754 on 2 occasions (14 days apart) with and without food (ie, a standard meal); JNJ-28431754 will be administered to volunteers as "open-label" treatment (ie, volunteers will know that they are receiving active drug) . Part 2 will begin after sufficient data has been collected from Part 1 to select the dose of JNJ-28431754 for Part 2 of the study (the dose selected will be within the dose range evaluated in Part 1 of the study). Volunteers will be required to stay overnight in the CRU for 5 nights on 2 occasions to receive study drug and to have post dose safety, tolerability, PK, and PD assessments performed. Patients will return to the CRU for a final safety follow-up visit 10 to 14 days after the 2nd single-dose administration of JNJ-38431754. For each volunteer, the total duration of Part 2 of the study will be approximately 7 weeks (includes a 3-week screening period and about a 2-week interval between the 2 single-dose administrations of JNJ 38431754). Volunteers in Part 1 and Part 2 of the study will be monitored for safety during the study by evaluating adverse events reported and results from vital signs measurements, electrocardiograms, physical examinations performed and laboratory tests. Part 1: One dose of JNJ-28431754 (10mg to 600mg) or placebo will be administered after an overnight fast of at least 10 hours (for additional cohorts, previously tested doses will be administered as 2 equally divided doses taken 10 hours apart). Part 2: One dose of JNJ-28431754 will be administered on 2 occasions (14 days apart) after an overnight fast of at least 10 hours with and without a standard meal. All doses of study drug will be administered to patients orally using an oral dispenser.

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.
71

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

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Have body mass index (BMI) between 20.0 and 29.9 kg/m2 inclusive
  • Be a non-smoker or non-tobacco user (not smoked cigarettes or used tobacco-containing products for at least 6 months prior to screening)
  • Have competency in speaking and comprehending the language where the study will be conducted

Exclusion Criteria:

  • Have history, or family history of bleeding or coagulation disorders or history of disorders that are potential causes of occult (test positive for fecal blood test without visible blood in feces) gastrointestinal bleeding
  • Have currently active skin disorders
  • Have history of renal or urinary tract diseases
  • Have history of having chronically taken (daily administration for more than 7 days) oral steroids, topical iodine, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants or other drugs known to interfere with blood clotting within 3 months of study start, or anticipates a need to take any of these during the course of the study
  • Have history of recent major surgery (within 6 months of study start)
  • Have history of recent travel (within 6 months) to locations that may predispose to the acquisition of communicable illnesses (e.g., parasitic or water-borne illnesses in developing tropical regions)
  • Have recent history of alcohol or drug abuse within 6 months prior to screening

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: Parallel 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: 001
JNJ-28431754/ Placebo Part 1: One oral dose of JNJ 28431754 (10 mg to 600 mg) or matching placebo will be administered after an overnight fast of at least 10 hours .For patients who receive a previously tested dose as 2 equally divided doses the evening dose will be administered at 10 hours after the morning dose.
Drug: JNJ-28431754/ Placebo
Part 1: One oral dose of JNJ 28431754 (10 mg to 600 mg) or matching placebo will be administered after an overnight fast of at least 10 hours .For patients who receive a previously tested dose as 2 equally divided doses, the evening dose will be administered at 10 hours after the morning dose.
Experimental: 002
JNJ-28431754 Part 2: A single dose of JNJ-28431754 will be orally administered on 2 occasions (14 days apart) after an overnight fast of at least 10 hours with and without a standard meal.
Drug: JNJ-28431754
Part 2: A single dose of JNJ-28431754 will be orally administered on 2 occasions (14 days apart) after an overnight fast of at least 10 hours with and without a standard meal.

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
Time Frame
Safety and tolerability assessed by evaluating adverse events reported and results from vital signs measurements, electrocardiograms, physical examinations performed and laboratory tests.
Time Frame: From Screening (within 21 days prior to Day 1) up to Day 14 or at the time of early withdrawal
From Screening (within 21 days prior to Day 1) up to Day 14 or at the time of early withdrawal

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
Time Frame
Urine Glucose Excretion (the amount of glucose excreted in the urine per 24 hours and the amount of glucose excreted in each urine collection fraction)
Time Frame: At protocol-specified timepoints before and after study drug administration on Day 1
At protocol-specified timepoints before and after study drug administration on Day 1
The renal threshold for Urinary Glucose Excretion
Time Frame: At protocol-specified timepoints before and after study drug administration on Day 1
At protocol-specified timepoints before and after study drug administration on Day 1
Plasma glucose, serum insulin and serum C peptide concentrations measured from blood samples collected
Time Frame: At protocol-specified timepoints before and after study drug administration on Day 1
At protocol-specified timepoints before and after study drug administration on Day 1

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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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, 2006

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.
April 1, 2007

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.
April 1, 2007

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).
August 5, 2010

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.
August 5, 2010

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.
August 6, 2010

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.
August 11, 2010

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.
August 10, 2010

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.
August 1, 2010

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.
  • CR012454
  • 28431754NAP1001

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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