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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)
Assessment method [1] 0 0
Area under the curve (AUC) from time zero to infinity (AUC0-8) and from time zero to the last quantifiable concentration (AUC0-last)
Timepoint [1] 0 0
Day 1 to Day 14
Primary outcome [2] 0 0
Maximum observed plasma concentration
Assessment method [2] 0 0
Maximum observed plasma concentration (Cmax) after dosing of both treatments
Timepoint [2] 0 0
Day 1 to Day 14
Secondary outcome [1] 0 0
Time to the maximum observed plasma concentration
Assessment method [1] 0 0
Time to the maximum observed plasma concentration (tmax)
Timepoint [1] 0 0
Day 1 to Day 14
Secondary outcome [2] 0 0
Number of adverse events observed
Assessment method [2] 0 0
Number of incidences of adverse events observed with respect to severity and relatedness to study treatment.
Timepoint [2] 0 0
Day 1 to Day 20-22
Secondary outcome [3] 0 0
Apparent plasma terminal elimination half-life
Assessment method [3] 0 0
Apparent plasma terminal elimination half-life (t1/2) after dosing of both treatments
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Marietta Franco, MS
Address 0 0
Apollomics Inc.
Country 0 0
Phone 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
Email 0 0
Yufei.Chen@apollomicsinc.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.