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

NCT06435039 | Terminated Phase 1 DMC

• 1 other identifier: YHGT-APL1501-NHS-103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Bladder Cancer

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Adverse Events (AEs)

  From Baseline up to Day 9

• Number of Participants With Abnormal Vital Sign Measurements

  From Baseline up to Day 9

• Number of Participants With Abnormal 12-Lead Electrocardiogram (ECGs) Recordings

  From Baseline up to Day 9

• Number of Participants With Abnormal Physical Examinations

  From Baseline up to Day 9

• Number of Participants With Abnormal Clinical Laboratory Values

  From Baseline up to Day 9

Secondary Outcomes (19)

• AUC0-t: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules

  Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose

• AUC0-inf: Area Under the Concentration-time Curve From Time Zero to Infinity of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules

  Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose

• Cmax: Maximal Observed Concentration of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules

  Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose

• Tlast: Time When the Last Concentration is Observed of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules

  Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose

• Tmax: Time When the Cmax is Observed of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules

  Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose

Study Arms (5)

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

EXPERIMENTAL

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.

Drug: APL-1202; Drug: APL-1501

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

EXPERIMENTAL

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.

Drug: APL-1202; Drug: APL-1501

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

EXPERIMENTAL

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.

Drug: APL-1202; Drug: APL-1501

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

EXPERIMENTAL

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.

Drug: APL-1202; Drug: APL-1501

Cohort 3: APL-1501 ER 1528 mg

EXPERIMENTAL

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

Drug: APL-1501

Interventions

APL-1202 DRUG

APL-1202 IR tablets.

Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg; Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg; Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg; Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg

APL-1501 DRUG

APL-1501 ER capsules.

Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg; Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg; Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg; Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg; Cohort 3: APL-1501 ER 1528 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria to be included in the study:
• 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).
• 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).
• Healthy as defined by:
• the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
• the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• Sexually active non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
• Able to understand the study procedures and provide signed informed consent to participate in the study.

You may not qualify if:

• Participants to whom any of the following applies will be excluded from the study:
• Any clinically significant abnormal finding at physical examination.
• 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.
• Positive urine drug screen, cotinine test, or alcohol breath test.
• History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
• 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.
• 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.
• 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%).
• Use of medications within the timeframes specified in section.
• 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.
• 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.
• Optic nerve disease, cataracts, or a history of related conditions.
• Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Sponsors & Collaborators

• Syneos Health: lead
• Asieris Pharmaceuticals (AUS) Pty Ltd.: collaborator

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Dr Christopher Argent

  Asieris Pharmaceuticals (AUS) Pty Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 30, 2024
• Study Start: June 21, 2024
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)