HealthyPhase 1NCT06492525
A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers
A Phase 1 study testing Ensartinib, Rifampicin and Itraconazole in people with Healthy, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ensartinib, Rifampicin and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Jul 2024to Dec 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;
- Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
- The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
- Able to comprehend and willing to sign an informed consent form.
Who cannot join
- Those with a history of chronic systemic or serious diseases such as cardiovascular, liver, kidney, lung, gastrointestinal, nervous, musculoskeletal, hematopoietic or metabolic diseases, especially surgical conditions or conditions that may affect drug absorption, distribution, metabolism and excretion；
- Family history or presence of long QTc syndrome; History or presence of an abnormal ECG；
- Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody or human immunodeficiency virus antigen/antibody (HIV-Ag/Ab) is positive；
- Use of any medications (prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, moderate or strong CYP3A inhibitors or inducers, etc) within 14 days prior to the first administration；
- Those who have special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages) and are unable to withdraw during the trial；
- Drug abusers, smokers or alcoholics；
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- Those with a history of fear of needles and hemophobia, difficulty in blood collection or inability to tolerate venipuncture blood collection;
- Donation of blood ≥ 400 mL or receipt of blood products within 3 months before enrollment;
- Receive any vaccine within 1 months before enrollment；
- Participation in any other investigational drug study within 3 months before enrollment；
- History of significant hypersensitivity to any drug compound or food；
- Other conditions that, in the opinion of the investigator, are not suitable for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: A Phase 1, Open-label, 2-period, Fixed Sequence, Cross-over Study To Investigate The Effect Of Multiple Doses Of Rifampicin Or Itraconazole On The Pharmacokinetics Of Single Dose Ensartinib In Healthy Volunteers.
The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.
- Conditions
- Healthy
- Being tested
- Ensartinib, Rifampicin, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsartinibDrug
225 mg oral dose on day 1 in period 1 and on day 18 in period 2
RifampicinDrug
600 mg QD from day 9 to day 22 in period 2
ItraconazoleDrug
200 mg QD from day 9 to day 19 in period 2
EnsartinibDrug
100 mg oral dose on day 1 in period 1 and on day 12 in period 2
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | All subjects in this cohort will receive the same dose of Ensartinib in both periods. Subjects will receive Ensartinib Alone in Period 1 followed by Ensartinib with Rifampicin in Period 2. Receives: Drug: Ensartinib; Drug: Rifampicin |
| Cohort 2 | Experimental | All subjects in this cohort will receive the same dose of Ensartinib in both periods. Subjects will receive Ensartinib Alone in Period 1 followed by Ensartinib with Itraconazole in Period 2. Receives: Drug: Itraconazole; Drug: Ensartinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma AUC0-t for Ensartinib Given Alone and With Rifampicin
AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.
Plasma AUC0-t for Ensartinib Given Alone and With Itraconazole
AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.
Plasma AUC0-∞ for Ensartinib Given Alone and With Rifampicin
AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.
Plasma AUC0-∞ for Ensartinib Given Alone and With Itraconazole
AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.
Plasma Cmax for Ensartinib Given Alone and With Rifampicin
Maximum plasma concentration
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.
Plasma Cmax for Ensartinib Given Alone and With Itraconazole
Maximum plasma concentration
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492525
- Sponsor's protocol ID
- BTP-42319
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 2-period, Fixed Sequence, Cross-over Study To Investigate The Effect Of Multiple Doses Of Rifampicin Or Itraconazole On The Pharmacokinetics Of Single Dose Ensartinib In Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT06492525
- Acronym / sponsor ID
- BTP-42319
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Jul 2024 (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.
The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Ensartinib, Drug: RifampicinAll subjects in this cohort will receive the same dose of Ensartinib in both periods. Subjects will receive Ensartinib Alone in Period 1 followed by Ensartinib with Rifampicin in Period 2. |
| Cohort 2 | Experimental | Drug: Itraconazole, Drug: EnsartinibAll subjects in this cohort will receive the same dose of Ensartinib in both periods. Subjects will receive Ensartinib Alone in Period 1 followed by Ensartinib with Itraconazole in Period 2. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;
- Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
- The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
- Able to comprehend and willing to sign an informed consent form.
Key exclusion criteria (12 listed)
- Those with a history of chronic systemic or serious diseases such as cardiovascular, liver, kidney, lung, gastrointestinal, nervous, musculoskeletal, hematopoietic or metabolic diseases, especially surgical conditions or conditions that may affect drug absorption, distribution, metabolism and excretion；
- Family history or presence of long QTc syndrome; History or presence of an abnormal ECG；
- Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody or human immunodeficiency virus antigen/antibody (HIV-Ag/Ab) is positive；
- Use of any medications (prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, moderate or strong CYP3A inhibitors or inducers, etc) within 14 days prior to the first administration；
- Those who have special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages) and are unable to withdraw during the trial；
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 |
|---|---|---|
| Ensartinib225 mg oral dose on day 1 in period 1 and on day 18 in period 2 | Drug | Cohort 1 |
| Rifampicin600 mg QD from day 9 to day 22 in period 2 | Drug | Cohort 1 |
| Itraconazole200 mg QD from day 9 to day 19 in period 2 | Drug | Cohort 2 |
| Ensartinib100 mg oral dose on day 1 in period 1 and on day 12 in period 2 | Drug | Cohort 2 |
Primary outcome
Plasma AUC0-t for Ensartinib Given Alone and With Rifampicin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.
AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Plasma AUC0-t for Ensartinib Given Alone and With Itraconazole
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.
AUC0-t is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast).
Plasma AUC0-∞ for Ensartinib Given Alone and With Rifampicin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.
AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Plasma AUC0-∞ for Ensartinib Given Alone and With Itraconazole
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.
AUC0-∞ is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Plasma Cmax for Ensartinib Given Alone and With Rifampicin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.
Maximum plasma concentration
Plasma Cmax for Ensartinib Given Alone and With Itraconazole
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 hours post-dose on Day 1 after Ensartinib 100 mg administration in Period 1, and at the same time points on Day 12 after Ensartinib 100 mg with Itraconazole administration in Period 2.
Maximum plasma concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 Ensartinib, Rifampicin and Itraconazole in people with Healthy, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. 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 9 Jul 2024. 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 China. 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 Bo Jiang, Ph.D (0571-87783759, jiangbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma AUC0-t for Ensartinib Given Alone and With Rifampicin (time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 after Ensartinib 225 mg administration in Period 1, and at the same time points on Day 18 after Ensartinib 225 mg with rifampin administration in Period 2.). The study lists 6 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 9 Jul 2024.