Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

August 28, 2018 updated by: EA Pharma Co., Ltd.

A First-in-Human, Randomised, Double Blind, Placebo Controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the same population. This study will also aim to determine the single and multiple oral ascending dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347 and its metabolite in the same population.

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.

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.
200

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

  • United Kingdom
      • Leeds, United Kingdom
        • Covance Clinical Research Unit (CRU) Ltd

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 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Main Inclusion Criteria for all participants:

  • Participants will be male
  • Participants will be in good health

Main Inclusion Criteria for Japanese participants:

  • Be ≥20 to ≤45 years of age
  • Have body mass index (BMI) ≥18.5 to ≤25.0 kilograms per meters squared (kg/m^2)
  • Be Japanese

Main Inclusion Criteria for Caucasian participants:

  • Be ≥18 to ≤45 years of age
  • Have a BMI ≥18.5 to ≤30.0 kg/m^2
  • Be Caucasian

Exclusion Criteria:

Main Exclusion Criteria for all participants:

Participants will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated.

  • Participants who have donated or lost ≥200 milliliters (mL) blood within 1 month or ≥400 mL within 3 months prior to Check-in
  • Participants who have an abnormality in heart rate, blood pressure, temperature, or respiration rate at Screening

  • Participants who have:

    • a positive urine drugs of abuse screen;
    • a positive alcohol breath test
  • Participants who have an abnormality in the 12-lead electrocardiogram (ECG) at Screening
  • Participants who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first dose administration
  • Participants who have a significant history of drug allergy, as determined by the Investigator
  • Participants who have any clinically significant abnormal physical examination finding

  • Participants who:

    • are carriers of the hepatitis B surface antigen (HBsAg);
    • are carriers of the hepatitis C antibody;
    • have a positive result for the test for human immunodeficiency virus (HIV) antibodies
  • Participants who, in the opinion of the Investigator, should not participate in this study

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

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: AJM347
Caucasian and Japanese participants will be randomized to receive one of eight and four single oral doses of AJM347, respectively, administered in the fasted state on Day 1.
Drug: AJM347
Oral administration
PLACEBO_COMPARATOR: Part 1: Placebo
Caucasian and Japanese participants will be randomized to receive one of eight and four single oral doses of matching placebo, respectively, administered in the fasted state on Day 1.
Drug: Placebo
Oral administration
EXPERIMENTAL: Part 2: Low-dose AJM347
Caucasian and Japanese participants will receive a "low" dose of AJM347 (at different frequencies and in either a fed or fasted state) on Day 1 of each of 6 sequential treatment periods.
Drug: AJM347
Oral administration
EXPERIMENTAL: Part 2: High-dose AJM347
Caucasian and Japanese participants will receive a "high" dose of AJM347 (at different frequencies and in either a fed or fasted state) on Day 1 of each of 2 sequential treatment periods (the frequency and timing with respect to meals will be determined after review of the data from the low-dose AJM347 groups).
Drug: AJM347
Oral administration
EXPERIMENTAL: Part 3: AJM347
Caucasian and Japanese participants will be randomized to receive one of three single doses of AJM347 on the morning of Day 1 and multiple daily doses beginning on the morning of Day 3, with the last dose received on the evening of Day 9. The actual doses, dosing frequencies, and timings with respect to meals to be employed in Part 3 of the study will be determined after review of the data from dose groups in Parts 1 and 2 of the study.
Drug: AJM347
Oral administration
PLACEBO_COMPARATOR: Part 3: Placebo
Caucasian and Japanese participants will be randomized to receive one of three single doses of matching placebo on the morning of Day 1 and multiple daily doses beginning on the morning of Day 3, with the last dose received on the evening of Day 9. The actual doses, dosing frequencies, and timings with respect to meals to be employed in Part 3 of the study will be determined after review of the data from dose groups in Parts 1 and 2 of the study.
Drug: Placebo
Oral administration

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 any adverse event (AE)
Time Frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product.
Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)

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
Number of participants with abnormal, clinically significant physical examination findings
Time Frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Clinical significance will be determined by the investigator.
Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Number of participants with abnormal, clinically significant vital sign values
Time Frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Clinical significance will be determined by the investigator.
Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Number of participants with abnormal, clinically significant 12-lead electrocardiogram (ECG) values
Time Frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Clinical significance will be determined by the investigator.
Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Number of participants with abnormal, clinically significant clinical laboratory values
Time Frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Clinical significance will be determined by the investigator.
Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Mean plasma concentrations of AJM347 and its metabolite
Time Frame: Part 1, Days 1 to 3; Part 2, Days 1 to 3; Part 3, Days 1 to 3, Day 7, Days 9 to 11 (Parts 1, 2, and 3 are not continuous)
Blood samples will be collected at the specified time points for the determination of plasma concentrations of AJM347 and its metabolite.
Part 1, Days 1 to 3; Part 2, Days 1 to 3; Part 3, Days 1 to 3, Day 7, Days 9 to 11 (Parts 1, 2, and 3 are not continuous)
Mean urinary concentrations of AJM347 and its metabolite
Time Frame: Part 1, Days 1 to 3; Part 3, Days 1 to 10
Urine samples will be collected at the specified time points for the determination of urine concentrations of AJM347 and its metabolite.
Part 1, Days 1 to 3; Part 3, Days 1 to 10
Inhibition rate of ligand-binding activity
Time Frame: Part 1, Days 1 and 2; Part 3, Days 1 and 2, Days 7, 9, and 10
The rate of inhibition of ligand-protein binding will be measured.
Part 1, Days 1 and 2; Part 3, Days 1 and 2, Days 7, 9, and 10

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.
EA Pharma Co., Ltd.

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 (ACTUAL)

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.
July 25, 2017

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.
July 6, 2018

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.
July 6, 2018

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).
April 25, 2017

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.
April 25, 2017

First Posted (ACTUAL)

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.
April 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

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 29, 2018

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 28, 2018

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.
July 1, 2018

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.
  • AJM347/CP1
  • 2017-000259-17 (EUDRACT_NUMBER)
  • 1009306/8349634 (OTHER: Covance Clinical Research Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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