Healthy SubjectsPhase 1NCT06089733

A Clinical Trial to Evaluate the Effect of Itraconazole and Rifampicin on ABSK021

A Phase 1 study testing Part A ABSK201 and Itraconazole and Part A ABSK201 and Rifampicin in people with Healthy Subjects, run by Abbisko Therapeutics Co, Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Part A ABSK201 and Itraconazole and Part A ABSK201 and Rifampicin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteChina
Study dates: 11 Apr 2023to 1 Sep 2023
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

Healthy subjects aged between 18 and 45 years old (including 18 and 45 years old) during screening, with no less than 6 single gender subjects in each group;
Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28), BMI=weight (kg)/height (m) ^2;
Medical history, physical examination, clinical laboratory examination, and other relevant examinations before screening that have been determined by the researcher to be normal or abnormal without clinical significance;
Male or female subjects with Fertility must agree to use an effective contraceptive method (see 5.4 for details) during the study period and within 6 months after the last dose of test drug administration, and male subjects will not donate sperm during this period; Female subjects must be non pregnant and non breast-feeding female subjects. Pregnancy is defined as women who are pregnant until the termination of pregnancy. It is determined by the laboratory hCG test within 7 days before the start of the study;
Voluntarily participate in this clinical trial, understand the research procedure, and sign an informed consent form before screening; Good compliance and willingness to follow research procedures.

Who cannot join

If there is a history of cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or Nervous system disease diseases, the absorption, metabolism or elimination of drugs are significantly affected, and the investigator judges that the use of experimental drugs may pose risks, interfere with the interpretation of data or affect the ability of subjects to participate in the study;
Known or persistent mental disorders that may interfere with the participant's participation in the study, as determined by the researcher;
Known to have a history of allergy to food, experimental drug ABSK021, Rifampicin, Itraconazole or other drugs;
Those who have participated in drug clinical trials as subjects within the past 3 months;
I have previously participated in this study or any other studies related to ABSK021 as a subject and have taken ABSK021.
Those who have applied CYP3A4 strong inhibitor or inducer within 14 days before the first administration (including Grapefruit juice, Grapefruit hybrids, pomegranate, carambola, grapefruit, seville orange, juice or other processed products);

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There are factors that significantly affect the absorption, distribution, metabolism and excretion of drugs, such as inability to take test drugs orally, obvious nausea, vomiting and Malabsorption;
Those who are unwilling to comply with the dietary requirements/restrictions during the study period, the specific dietary requirements are: (i) only consume the meals provided by the research center during hospitalization, (ii) avoid consuming CYP3A4 strong inhibitors or inducers during the study period;
Within the first 3 months of screening, those who consume more than 14 units of alcohol per week (1 unit of alcohol is approximately 360mL of beer or 45mL of 40% alcohol or 150mL of wine), or who are positive for alcohol screening, or are unwilling to comply with the alcohol restrictions specified in section 5.3.3;
Smoking at least 5 cigarettes per day (or corresponding amounts of tobacco or nicotine products) within the first 3 months of screening; Or those who are unwilling to comply with the smoking restrictions specified in Section 5.3.3;
The researcher judged that there were people who had excessive intake of methyl Xanthine/caffeine in the past 6 months (excessive intake is defined as more than 6 units of caffeine per day, and 1 unit of caffeine is equivalent to 177 milliliters of coffee, 355 milliliters of tea, 355 milliliters of cola, or 85 grams of chocolate), or were unwilling to comply with the restrictions on the use of methyl Xanthine/caffeine in 5.3.3 during the study period;
People with positive serum hepatitis B B surface antigen (HBsAg), hepatitis B B e antigen (HBeAg), hepatitis B B e antibody (HBeAb), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, HIV (HIV) antibody screening;
Those with a history of bacterial, fungal, parasitic, viral (excluding nasopharyngitis, COVID-19), mycobacterial infection, or clinically significant abnormal chest X-ray results within 45 days before the first administration (determined by the investigator);

Trial locations and contacts

1 site in 1 country.

China1 site

Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 201203

Other trials in China

About this study

Official title: a Single-center, Open-label, Fixed Sequence Study in Healthy Chinese Subjects to Evaluate the Pharmacokinetic Effects of Itraconazole and Rifampicin on Oral Administration of a Single Dose of ABSK021

This study is a single center, open lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of ABSK021 Oral administration. It is planned to enroll 32 healthy subjects and assign them to two parallel test groups, Part A (ABSK021 combined with Itraconazole) and Part B (ABSK021 combined with Rifampicin).

Read the detailed description

Each study section includes a screening period conducted within 28 days prior to the first administration of the investigational drug, a trial period of 2 cycles, and withdrawal visits on the 21st or 14th day (Part A) or 14th day (Part B) after the last dose of ABSK021. This study will end after all participants complete 2 cycles of the trial period and withdraw from the study visit.

Whether subjects who have completed the first cycle of the study will enter the second cycle of the study will be determined by the researcher based on their physical condition and relevant visit examination results. For the subjects who interrupted or permanently suspended the study due to adverse events or clinically significant laboratory Outlier, the interview rate shall be determined according to the requirements of the research institution or the clinical indication syndrome until the AE is resolved or stabilized, whichever occurs first.

Conditions: Healthy Subjects
Being tested: Part A ABSK201 and Itraconazole, Part A ABSK201 and Rifampicin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Part A ABSK201 and ItraconazoleDrug
Subjects will receive a single 10mg Oral administration of ABSK021 at C1D1, followed by a washout period of at least 14 days. The second cycle (C2): after the end of the first cycle, the subjects will receive 200 mg of C2D1-C2D24 Itraconazole oral liquid and a single 10 mg of ABSK021 Oral administration at C2D4.
Part A ABSK201 and RifampicinDrug
Subjects will receive a single dose of 50 mg of ABSK021 Oral administration once at C1D1, followed by a washout period of at least 14 days. Subjects will receive 600 mg of Rifampicin capsules once a day at C2D1-C2D15 and a single dose of ABSK021 Oral administration at C2D7, with the dose of 50 mg.

Study groups in NCT06089733
Study group	Role	What they receive
ABSK201 and Itraconazole/Rifampicin	Experimental	Part A: Subjects will receive a single 10mg Oral administration of ABSK021 at C1D1, followed by a washout period of at least 14 days. The second cycle (C2): after the end of the first cycle, the subjects will receive 200 mg of C2D1-C2D24 Itraconazole oral liquid and a single 10 mg of ABSK021 Oral administration at C2D4. Part B: Subjects will receive a single dose of 50 mg of ABSK021 Oral administration once at C1D1, followed by a washout period of at least 14 days. Subjects will receive 600 mg of Rifampicin capsules once a day at C2D1-C2D15 and a single dose of ABSK021 Oral administration at C2D7, with the dose of 50 mg. Receives: Drug: Part A ABSK201 and Itraconazole; Drug: Part A ABSK201 and Rifampicin

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A_(1)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration of ABSK021 capsules and combination of itraconazole oral solution using Peak Plasma Concentration (Cmax)
Collect plasma samples of ABSK021 and its metabolites (if data allows), as well as itraconazole and its metabolite hydroxyitraconazole, from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are collected at C1 and C2, while plasma samples of itraconazole and its metabolite hydroxyitraconazole are collected at C2.
Measured: Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol
Part A_(2)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration of ABSK021 capsules and combination of itraconazole oral solution using Area under the plasma concentration versus time curve (AUC)
Collect plasma samples of ABSK021 and its metabolites (if data allows), as well as itraconazole and its metabolite hydroxyitraconazole, from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are collected at C1 and C2, while plasma samples of itraconazole and its metabolite hydroxyitraconazole are collected at C2.
Measured: Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol
Part B_(1)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration and in combination with Rifampicin using Peak Plasma Concentration (Cmax).
Collect plasma samples of ABSK021 and its metabolites (if data allows) and rifampicin from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are sampled at C1 and C2, while rifampicin plasma samples are sampled at C2.
Measured: Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol
Part B_(2)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration and in combination with Rifampicin using Area under the plasma concentration versus time curve (AUC).
Collect plasma samples of ABSK021 and its metabolites (if data allows) and rifampicin from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are sampled at C1 and C2, while rifampicin plasma samples are sampled at C2.
Measured: Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 20231 Sep 2023

First posted18 Oct 2023
Study start11 Apr 2023
Primary completion30 Aug 2023
Study completion1 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
More trials run by Abbisko Therapeutics Co, LtdThe 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of \[14C\] ABSK021 in the fasted state.
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06089733
Sponsor's protocol ID: ABSK021-103
Status last verified: Jun 2023
First submitted: 13 Jun 2023
Last updated: 12 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: a Single-center, Open-label, Fixed Sequence Study in Healthy Chinese Subjects to Evaluate the Pharmacokinetic Effects of Itraconazole and Rifampicin on Oral Administration of a Single Dose of ABSK021
ClinicalTrials.gov ID: NCT06089733
Acronym / sponsor ID: ABSK021-103
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
Study start: 11 Apr 2023 (actual)
Primary completion: 30 Aug 2023 (actual)
Study completion: 1 Sep 2023 (actual)
First posted: 18 Oct 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state.

Arm	Type	Receives
ABSK201 and Itraconazole/Rifampicin	Experimental	Drug: Part A ABSK201 and Itraconazole, Drug: Part A ABSK201 and RifampicinPart A: Subjects will receive a single 10mg Oral administration of ABSK021 at C1D1, followed by a washout period of at least 14 days. The second cycle (C2): after the end of the first cycle, the subjects will receive 200 mg of C2D1-C2D24 Itraconazole oral liquid and a single 10 mg of ABSK021 Oral administration at C2D4. Part B: Subjects will receive a single dose of 50 mg of ABSK021 Oral administration once at C1D1, followed by a washout period of at least 14 days. Subjects will receive 600 mg of Rifampicin capsules once a day at C2D1-C2D15 and a single dose of ABSK021 Oral administration at C2D7, with the dose of 50 mg.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy subjects aged between 18 and 45 years old (including 18 and 45 years old) during screening, with no less than 6 single gender subjects in each group;
Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28), BMI=weight (kg)/height (m) ^2;
Medical history, physical examination, clinical laboratory examination, and other relevant examinations before screening that have been determined by the researcher to be normal or abnormal without clinical significance;
Male or female subjects with Fertility must agree to use an effective contraceptive method (see 5.4 for details) during the study period and within 6 months after the last dose of test drug administration, and male subjects will not donate sperm during this period; Female subjects must be non pregnant and non breast-feeding female subjects. Pregnancy is defined as women who are pregnant until the termination of pregnancy. It is determined by the laboratory hCG test within 7 days before the start of the study;
Voluntarily participate in this clinical trial, understand the research procedure, and sign an informed consent form before screening; Good compliance and willingness to follow research procedures.

Key exclusion criteria (13 listed)

If there is a history of cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or Nervous system disease diseases, the absorption, metabolism or elimination of drugs are significantly affected, and the investigator judges that the use of experimental drugs may pose risks, interfere with the interpretation of data or affect the ability of subjects to participate in the study;
Known or persistent mental disorders that may interfere with the participant's participation in the study, as determined by the researcher;
Known to have a history of allergy to food, experimental drug ABSK021, Rifampicin, Itraconazole or other drugs;
Those who have participated in drug clinical trials as subjects within the past 3 months;
I have previously participated in this study or any other studies related to ABSK021 as a subject and have taken ABSK021.

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
Part A ABSK201 and ItraconazoleSubjects will receive a single 10mg Oral administration of ABSK021 at C1D1, followed by a washout period of at least 14 days. The second cycle (C2): after the end of the first cycle, the subjects will receive 200 mg of C2D1-C2D24 Itraconazole oral liquid and a single 10 mg of ABSK021 Oral administration at C2D4.	Drug	ABSK201 and Itraconazole/Rifampicin
Part A ABSK201 and RifampicinSubjects will receive a single dose of 50 mg of ABSK021 Oral administration once at C1D1, followed by a washout period of at least 14 days. Subjects will receive 600 mg of Rifampicin capsules once a day at C2D1-C2D15 and a single dose of ABSK021 Oral administration at C2D7, with the dose of 50 mg.	Drug	ABSK201 and Itraconazole/Rifampicin

Primary outcome

Part A_(1)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration of ABSK021 capsules and combination of itraconazole oral solution using Peak Plasma Concentration (Cmax)
Time frame: Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol
Collect plasma samples of ABSK021 and its metabolites (if data allows), as well as itraconazole and its metabolite hydroxyitraconazole, from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are collected at C1 and C2, while plasma samples of itraconazole and its metabolite hydroxyitraconazole are collected at C2.
Part A_(2)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration of ABSK021 capsules and combination of itraconazole oral solution using Area under the plasma concentration versus time curve (AUC)
Time frame: Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol
Collect plasma samples of ABSK021 and its metabolites (if data allows), as well as itraconazole and its metabolite hydroxyitraconazole, from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are collected at C1 and C2, while plasma samples of itraconazole and its metabolite hydroxyitraconazole are collected at C2.
Part B_(1)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration and in combination with Rifampicin using Peak Plasma Concentration (Cmax).
Time frame: Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol
Collect plasma samples of ABSK021 and its metabolites (if data allows) and rifampicin from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are sampled at C1 and C2, while rifampicin plasma samples are sampled at C2.
Part B_(2)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration and in combination with Rifampicin using Area under the plasma concentration versus time curve (AUC).
Time frame: Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol
Collect plasma samples of ABSK021 and its metabolites (if data allows) and rifampicin from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are sampled at C1 and C2, while rifampicin plasma samples are sampled at C2.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 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.

Jing Zhang, Professor principal investigator

Huashan Hospital

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 Part A ABSK201 and Itraconazole and Part A ABSK201 and Rifampicin in people with Healthy Subjects, run by Abbisko Therapeutics 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 12 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A_(1)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration of ABSK021 capsules and combination of itraconazole oral solution using Peak Plasma Concentration (Cmax) (time frame: Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06089733.

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 12 Aug 2024.