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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05367388




Registration number
NCT05367388
Ethics application status
Date submitted
3/05/2022
Date registered
10/05/2022
Date last updated
15/06/2022

Titles & IDs
Public title
A Study Comparing Two Different Capsules, APL-101 and PLB-1001 Capsules, in Healthy Chinese and Caucasian Participants
Scientific 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
Secondary ID [1] 0 0
APL-101-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioequivalence 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - APL-101
Treatment: Drugs - PLB-1001

Experimental: Treatment Sequence A/P - Subject will receive a single oral dose (200mg) of Treatment A on Day 1, followed by a 7-day washout period. On Day 8, the subject will begin the second treatment period by receiving a single oral dose (200 mg) of Treatment P.

Experimental: Treatment Sequence P/A - Subject will receive a single oral dose (200mg) of Treatment P on Day 1, followed by a 7-day washout period. On Day 8, the subject will begin the second treatment period by receiving a single oral dose (200 mg) of Treatment A.


Treatment: Drugs: APL-101
APL-101 (Vebreltinib) is an orally available small molecule, which is a tyrosine kinase inhibitor (TKI) for the mesenchymal epithelial transition protein tyrosine kinase receptor (c-Met) with high selectivity and potency.

The treatments to be administered in this study include:

• Treatment A (reference): Two 100 mg APL-101 (Vebreltinib) capsules (200 mg dose), manufactured for Apollomics, Inc.

Treatment: Drugs: PLB-1001
PLB-1001 (Bozitinib) is a chemical drug category 1.1 innovative drug. It is a highly effective and highly selective c-Met tyrosine kinase inhibitor.

The treatments to be administered in this study include:

• Treatment P (test): Two 100 mg PLB-1001 (Bozitinib) capsules (200 mg dose), manufactured for Beijing Pearl Biotechnology Co., Ltd.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the plasma concentration versus time curve (AUC)
Timepoint [1] 0 0
Day 1 to Day 14
Primary outcome [2] 0 0
Maximum observed plasma concentration
Timepoint [2] 0 0
Day 1 to Day 14
Secondary outcome [1] 0 0
Time to the maximum observed plasma concentration
Timepoint [1] 0 0
Day 1 to Day 14
Secondary outcome [2] 0 0
Number of adverse events observed
Timepoint [2] 0 0
Day 1 to Day 20-22
Secondary outcome [3] 0 0
Apparent plasma terminal elimination half-life
Timepoint [3] 0 0
Day 1 to Day 14

Eligibility
Key inclusion criteria
Major

* 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Apollomics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05367388
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marietta Franco, MS
Address 0 0
Apollomics Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yufei Chen, MS
Address 0 0
Country 0 0
Phone 0 0
650-209-4055
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05367388