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

EA Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: AJM347

Study type: Interventional

Funder types: Industry

Identifiers

NCT03133468

AJM347/CP1

2017-000259-17 (EudraCT Number)

1009306/8349634 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 6 patient groups, including a placebo group

Part 1: AJM347

Experimental group

Description:

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.

Treatment:

Drug: AJM347

Part 1: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Part 2: Low-dose AJM347

Experimental group

Description:

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.

Treatment:

Drug: AJM347

Part 2: High-dose AJM347

Experimental group

Description:

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).

Treatment:

Drug: AJM347

Part 3: AJM347

Experimental group

Description:

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.

Treatment:

Drug: AJM347

Part 3: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo