BioequivalencePhase 1NCT05367388
A Study Comparing Two Different Capsules, APL-101 and PLB-1001 Capsules, in Healthy Chinese and Caucasian Participants
A Phase 1 study testing APL-101 and PLB-1001 in people with Bioequivalence, run by Apollomics Inc. at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- APL-101 and PLB-1001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNew Zealand
- Study dates
- 20 May 2022to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research
Auckland
Trial Manager, +1(650)209-4055 ext. 137, yufei.chen@apollomicsinc.com
About this study
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
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.
Read the 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.
- Conditions
- Bioequivalence
- Being tested
- APL-101, PLB-1001
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL-101Drug
Also called Bozitinib, Vebreltinib
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.
PLB-1001Drug
Also called Bozitinib
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence A/P | Experimental | 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. Receives: Drug: APL-101; Drug: PLB-1001 |
| Treatment Sequence P/A | Experimental | 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. Receives: Drug: APL-101; Drug: PLB-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
Area under the curve (AUC) from time zero to infinity (AUC0-∞) and from time zero to the last quantifiable concentration (AUC0-last)
Measured: Day 1 to Day 14
Maximum observed plasma concentration
Maximum observed plasma concentration (Cmax) after dosing of both treatments
Measured: Day 1 to Day 14
Secondary outcomes (3)
Time to the maximum observed plasma concentration
Time to the maximum observed plasma concentration (tmax)
Measured: Day 1 to Day 14
Number of adverse events observed
Number of incidences of adverse events observed with respect to severity and relatedness to study treatment.
Measured: Day 1 to Day 20-22
Apparent plasma terminal elimination half-life
Apparent plasma terminal elimination half-life (t1/2) after dosing of both treatments
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start20 May 2022
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apollomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marietta Franco, MS, Study director, Apollomics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367388
- Sponsor's protocol ID
- APL-101-03
- Status last verified
- Jun 2022
- First submitted
- 3 May 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05367388
- Acronym / sponsor ID
- APL-101-03
- Conditions
- Bioequivalence
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Apollomics Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence A/P | Experimental | Drug: APL-101, Drug: PLB-1001Subject 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. |
| Treatment Sequence P/A | Experimental | Drug: APL-101, Drug: PLB-1001Subject 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APL-101Also: Bozitinib, VebreltinibAPL-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. | Drug | Treatment Sequence A/P, Treatment Sequence P/A |
| PLB-1001Also: BozitinibPLB-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. | Drug | Treatment Sequence A/P, Treatment Sequence P/A |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 to Day 14
Area under the curve (AUC) from time zero to infinity (AUC0-∞) and from time zero to the last quantifiable concentration (AUC0-last)
Maximum observed plasma concentration
Time frame: Day 1 to Day 14
Maximum observed plasma concentration (Cmax) after dosing of both treatments
3 secondary outcomes
Time to the maximum observed plasma concentration
Time frame: Day 1 to Day 14
Number of adverse events observed
Time frame: Day 1 to Day 20-22
Apparent plasma terminal elimination half-life
Time frame: Day 1 to Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
Related trials for Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
RecruitingPhase 1
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marietta Franco, MS study director
Apollomics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APL-101 and PLB-1001 in people with Bioequivalence, run by Apollomics Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yufei Chen, MS (650-209-4055 ext. 137, Yufei.Chen@apollomicsinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) (time frame: Day 1 to Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.