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

NCT03133468 | Completed Phase 1

• 3 other identifiers: AJM347/CP12017-000259-171009306/8349634
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Keywords

AJM347; pharmacokinetics; food effect study; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Number of participants with any adverse event (AE)

  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 Outcomes (7)

• Number of participants with abnormal, clinically significant physical examination findings

  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

  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

  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

  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

  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)

Study Arms (6)

Part 1: AJM347

EXPERIMENTAL

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

Part 1: Placebo

PLACEBO COMPARATOR

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

Part 2: Low-dose AJM347

EXPERIMENTAL

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

Part 2: High-dose AJM347

EXPERIMENTAL

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

Part 3: AJM347

EXPERIMENTAL

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

Part 3: Placebo

PLACEBO COMPARATOR

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

Interventions

AJM347 DRUG

Oral administration

Part 1: AJM347; Part 2: High-dose AJM347; Part 2: Low-dose AJM347; Part 3: AJM347

Placebo DRUG

Oral administration

Part 1: Placebo; Part 3: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be male
• Participants will be in good health
• 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
• Be ≥18 to ≤45 years of age
• Have a BMI ≥18.5 to ≤30.0 kg/m\^2
• Be Caucasian

You may not qualify if:

• 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

Sponsors & Collaborators

• EA Pharma Co., Ltd.: lead

Study Sites (1)

Covance Clinical Research Unit (CRU) Ltd

Leeds, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 28, 2017
• Study Start: July 25, 2017
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)