A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers

NCT ID: NCT06435039

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-21
• Study Completion Date: 2024-07-16

Brief Summary

The primary objective of the study is to assess safety and tolerability following administration of single doses of APL-1202 (immediate release) IR tablets and APL-1501 extended release (ER) capsules in healthy participants.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg

Participants will receive APL-1202 375 milligram (mg) IR tablets, orally, once on Day 1 of Period 1 (Treatment R1), followed by T1 APL-1501 764 mg ER capsules, orally, once, on Day 4 of Period 2 (Treatment T1). A washout period of more than or equal to (\>=) 72 hours will be maintained in between Period 1 and 2.

Group Type: EXPERIMENTAL

APL-1202

Intervention Type: DRUG

APL-1202 IR tablets.

APL-1501

Intervention Type: DRUG

APL-1501 ER capsules.

Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg

Participants will receive APL-1501 764 mg ER capsules, orally, once on Day 1 of Period 1 (Treatment T1), followed by APL-1202 375 mg IR tablets, orally, once, on Day 4 of Period 2 (Treatment R1). A washout period of \>=72 hours will be maintained in between Period 1 and 2.

Group Type: EXPERIMENTAL

APL-1202

Intervention Type: DRUG

APL-1202 IR tablets.

APL-1501

Intervention Type: DRUG

APL-1501 ER capsules.

Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg

Participants will receive APL-1202 375 mg IR tablets, orally, once on Day 1 of Period 1 (Treatment R1), followed by APL-1501 1146 mg ER capsules, orally, once, on Day 4 of Period 2 (Treatment T2). A washout period of \>=72 hours will be maintained in between Period 1 and 2.

Group Type: EXPERIMENTAL

APL-1202

Intervention Type: DRUG

APL-1202 IR tablets.

APL-1501

Intervention Type: DRUG

APL-1501 ER capsules.

Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg

Participants will receive APL-1501 1146 mg ER capsules, orally, once on Day 1 of Period 1 (Treatment T2), followed by APL-1202 375 mg IR tablets, orally, once, on Day 4 of Period 2 (Treatment R1). A washout period of \>=72 hours will be maintained in between Period 1 and 2.

Group Type: EXPERIMENTAL

APL-1202

Intervention Type: DRUG

APL-1202 IR tablets.

APL-1501

Intervention Type: DRUG

APL-1501 ER capsules.

Cohort 3: APL-1501 ER 1528 mg

Participants will receive APL-1501 1528 mg ER capsules, orally, once on Day 1.

Group Type: EXPERIMENTAL

APL-1501

Intervention Type: DRUG

APL-1501 ER capsules.

Interventions

APL-1202

APL-1202 IR tablets.

Intervention Type: DRUG

APL-1501

APL-1501 ER capsules.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Participants must meet all of the following criteria to be included in the study:

1. Male, >=18 and less than or equal to (<=) 65 years of age, with body mass index (BMI) greater than (>) 18.5 and less than (<) 32.0 kilogram per square meter (kg/m^2) and body weight >=50.0 kilogram (kg).

2. Non-smoker (no use of tobacco or nicotine products, example, snuff, chewing tobacco, cigars, cigarettes, pipes, e-cigarettes [vaping] etc. within 3 months prior to screening).

3. Healthy as defined by:

1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.

2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.

4. Sexually active non-sterile males must be willing to use an acceptable contraceptive method throughout the study.

5. Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion Criteria

Participants to whom any of the following applies will be excluded from the study:

1. Any clinically significant abnormal finding at physical examination.

2. Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) antibody, or Human immunodeficiency virus (HIV) antigen and antibody.

3. Positive urine drug screen, cotinine test, or alcohol breath test.

4. History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.

5. Clinically significant Electrocardiograms (ECG) abnormalities or vital signs abnormalities (systolic blood pressure [BP] lower than 90 or over 140 millimeters of mercury [mmHg], diastolic BP lower than 50 or over 90 mmHg, heart rate [HR] less than 40 or over 100 beats per minute [bpm], or RR less than 10 or over 25 bpm) at screening.

6. History of drug abuse within 1 year prior to screening or recreational use of marijuana within 1 month or other illegal drugs such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives within 3 months prior to screening.

7. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units of alcohol per week (1 unit = 375 milliliter [mL] of beer 3.5 percent (%), or 100 mL of wine 13.5%, or 30 mL of distilled alcohol 40%).

8. Use of medications within the timeframes specified in section.

9. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.

10. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.

11. Optic nerve disease, cataracts, or a history of related conditions.

12. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Asieris Pharmaceuticals (AUS) Pty Ltd.

INDUSTRY

Sponsor Role: collaborator

Syneos Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Christopher Argent

Role: PRINCIPAL_INVESTIGATOR

Asieris Pharmaceuticals (AUS) Pty Ltd.

Locations

Scientia Clinical Research Ltd

Randwick, New South Wales, Australia

Countries

Australia

Other Identifiers

YHGT-APL1501-NHS-103

Identifier Type: -

Identifier Source: org_study_id