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Completed

NCT Number: NCT03133468

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit (CRU) Ltd

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AJM347

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

EA Pharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2017
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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