Clinical trial NCT05367388: A Study Comparing Two Different Capsules, APL-101 and PLB-1001 Capsules, in Healthy Chinese and Caucasian Participants
Official title: An Open-Label, Multi-Center, Randomized, 2-Way Crossover Study to Assess the Bioequivalence of APL-101 Capsule vs PLB-1001 Capsule in Healthy Chinese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bioequivalence
Keywords: Pharmacokinetics
Lead sponsor: Apollomics Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The treatment sequence will be determined using a 2×2 crossover design. This study includes an adaptive design feature of variable sample size.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, open-label, multi-center, randomized, 2-period, adaptive design, crossover study to assess the bioequivalence of APL-101 (Vebreltinib) capsules and PLB-1001 (Bozitinib) capsules.

The treatments to be administered orally in this study include:

* Treatment A (reference): Two 100 mg APL-101 (Vebreltinib) capsules (200 mg dose), manufactured for Apollomics, Inc
* Treatment P (test): Two 100 mg PLB-1001 (Bozitinib) capsules (200 mg dose), manufactured for Beijing Pearl Biotechnology Co., Ltd.

APL-101 capsules (Treatment A) and PLB-1001 capsules (Treatment P) are similar drug products.

Detailed description: Up to 48 healthy male subjects (approximately 16 Chinese and approximately 32 Caucasians) will be enrolled in the study in at least 2 sequential cohorts and randomly assigned to 1 of 2 treatment sequences. The treatment sequence will be determined using a 2×2 crossover design. This study includes an adaptive design feature of variable sample size. Data from the first 16 subjects will be used to determine the intra-subject variability to ensure a sufficient total sample size to achieve study objectives. If needed, up to 72 subjects will be enrolled.

Eligibility criteria: Major Inclusion Criteria:

* Must be Chinese (1st generation or 2nd generation Chinese with both Chinese parents), or Caucasian.
* Body mass index between 18.0 and 30.0 kg/m2, inclusive.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and at check-in as assessed by the Investigator (or designee). Screening clinical laboratory evaluations may be repeated once at the discretion of the Investigator.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 × the upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN at screening and check-in. Subjects with ALT or AST \>1.0 × ULN combined with total bilirubin \>1.0 × ULN are excluded.
* QT interval corrected for heart rate using Fridericia's method (QTcF) ≤ 450 msec confirmed by calculating the mean of the triplicate measurements within 4 weeks prior to Day 1.
* Systolic blood pressure between 100 and 140 mmHg or diastolic blood pressure between 50 and 90 mmHg, confirmed by calculating the mean of the triplicate measurements within 4 weeks prior to Day 1.

Major Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
* Have positive Coronavirus Disease 2019 (COVID-19) test at screening and/or at check-in, have clinical signs or symptoms of COVID-19 as determined by the Investigator, or have ongoing significant complication(s) from prior COVID-19 infection.
* Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 14 days prior to check in, unless deemed acceptable by the Investigator.
* Have previously completed or withdrawn from this study or any other study investigating APL 101 or similar drug product, and/or have previously received APL 101 or similar drug product.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Day 1 to Day 14
measure: Maximum observed plasma concentration
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: Time to the maximum observed plasma concentration
timeFrame: Day 1 to Day 14
measure: Number of adverse events observed
timeFrame: Day 1 to Day 20-22
measure: Apparent plasma terminal elimination half-life
timeFrame: Day 1 to Day 14
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
affiliation: Apollomics Inc.
name: Marietta Franco, MS
role: STUDY_DIRECTOR
References: