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

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

NCT ID: NCT06435039

Condition: Healthy Volunteers

Conditions: Keywords:
Bladder Cancer

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: APL-1202
Description: APL-1202 IR tablets.
Arm group label: Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg
Arm group label: Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg
Arm group label: Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg
Arm group label: Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg

Intervention type: Drug
Intervention name: APL-1501
Description: APL-1501 ER capsules.
Arm group label: Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg
Arm group label: Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg
Arm group label: Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg
Arm group label: Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg
Arm group label: Cohort 3: APL-1501 ER 1528 mg

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.

Criteria for 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.

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: June 26, 2024

Completion date: October 22, 2024

Lead sponsor:
Agency: Syneos Health
Agency class: Other

Collaborator:
Agency: Asieris Pharmaceuticals (AUS) Pty Ltd.
Agency class: Industry

Source: Syneos Health

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06435039