Healthy PersonPhase 1NCT05316857
DDI Study of Orelabrutinib
A Phase 1 study testing Orelabrutinib + Rifampin and Orelabrutinib + Itraconazole in people with Healthy Person, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
Trial summary
This is a phase I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Person
- What is being tested?
- Orelabrutinib + Rifampin and Orelabrutinib + 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
- 16 Dec 2021to 13 Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject who can fully understand the objectives, nature, methods and possible adverse reactions of the trial, and volunteers to be the subject, and has signed an informed consent form before the start of any study procedure, and guarantees that any procedure will be participated in by himself/herself;
- Male or female subjects aged between 18 and 45 years old (inclusive) at the time of screening;
- Body weight ≥50 kg for male subjects, ≥45 kg for female subjects, and a body mass index (BMI) of 19 to 26.0 kg/m2 (inclusive);
- Be able to communicate well with investigator, and understand and comply with the requirements of this study.
Who cannot join
- Complete physical examination, routine laboratory tests, cardiac color ultrasound and other examinations are abnormal with clinical significance;
- Hepatitis B surface antigen or E antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody are positive;
- C-reactive protein for novel coronavirus screening is abnormal with clinical significance, or the novel coronavirus nucleic acid testing is positive;
- Have received any drugs and therapy which are in the study protocol within 1 month before screening
- Have taken prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicine within 14 days before the first administration of the investigational drug
- Have any history of clinically serious diseases, or diseases or conditions that the investigator believes may affect the results of the study.
- Subject who has a childbirth plan during the study period and within 3 months after the end of the study, or the subject and his/her partner do not agree to take strict contraceptive measures during this period;
- Other subjects judged by the investigator as unsuitable to participate in this study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: A Phase I, Single-center, Open-label, Fixed-sequence Clinical Study to Evaluate the Effects of Multiple Administrations of Rifampin or Itraconazole on the Pharmacokinetic Characteristics of a Single Administration of Orelabrutinib Tablets in Healthy Subjects
This is a phase I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese subjects.
- Conditions
- Healthy Person
- Being tested
- Orelabrutinib + Rifampin, Orelabrutinib + Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib + RifampinDrug
Orelabrutinib + Rifampin
Orelabrutinib + ItraconazoleDrug
Orelabrutinib + Itraconazole
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib + Rifampin | Other | Orelabrutinib is a white, round, uncoated table,Subjects take high dose orelabrutinib in the first day and the tenth day.
Rifampin is a capsule,Subjects take 600mg QD rifampin in the third day to the eleventh. Receives: Drug: Orelabrutinib + Rifampin |
| Orelabrutinib + Itraconazole | Other | Orelabrutinib is a white, round, uncoated table,Subjects take low dose orelabrutinib in the first day and the eighth day.
Itraconazole is a capsule,Subjects take 600mg QD rifampin in the third day to the tenth. Receives: Drug: Orelabrutinib + Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include the peak plasma concentration (Cmax)
Measured: up to 3 months
Secondary outcomes (2)
Tmax
To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include Time to Maximum Plasma Concentration(Tmax)
Measured: up to 3 months
Incidence of Treatment-Emergent Adverse Events
To evaluate the safety and tolerability of Orelabrutinib
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start16 Dec 2021
- Primary completion4 Jan 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PersonStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316857
- Sponsor's protocol ID
- ICP-CL-00117
- Status last verified
- Jun 2022
- First submitted
- 25 Mar 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Open-label, Fixed-sequence Clinical Study to Evaluate the Effects of Multiple Administrations of Rifampin or Itraconazole on the Pharmacokinetic Characteristics of a Single Administration of Orelabrutinib Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05316857
- Acronym / sponsor ID
- ICP-CL-00117
- Conditions
- Healthy Person
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 7 Apr 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 I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib + Rifampin | Other | Drug: Orelabrutinib + RifampinOrelabrutinib is a white, round, uncoated table,Subjects take high dose orelabrutinib in the first day and the tenth day. Rifampin is a capsule,Subjects take 600mg QD rifampin in the third day to the eleventh. |
| Orelabrutinib + Itraconazole | Other | Drug: Orelabrutinib + ItraconazoleOrelabrutinib is a white, round, uncoated table,Subjects take low dose orelabrutinib in the first day and the eighth day. Itraconazole is a capsule,Subjects take 600mg QD rifampin in the third day to the tenth. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject who can fully understand the objectives, nature, methods and possible adverse reactions of the trial, and volunteers to be the subject, and has signed an informed consent form before the start of any study procedure, and guarantees that any procedure will be participated in by himself/herself;
- Male or female subjects aged between 18 and 45 years old (inclusive) at the time of screening;
- Body weight ≥50 kg for male subjects, ≥45 kg for female subjects, and a body mass index (BMI) of 19 to 26.0 kg/m2 (inclusive);
- Be able to communicate well with investigator, and understand and comply with the requirements of this study.
Key exclusion criteria (8 listed)
- Complete physical examination, routine laboratory tests, cardiac color ultrasound and other examinations are abnormal with clinical significance;
- Hepatitis B surface antigen or E antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody are positive;
- C-reactive protein for novel coronavirus screening is abnormal with clinical significance, or the novel coronavirus nucleic acid testing is positive;
- Have received any drugs and therapy which are in the study protocol within 1 month before screening
- Have taken prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicine within 14 days before the first administration of the investigational drug
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 |
|---|---|---|
| Orelabrutinib + RifampinOrelabrutinib + Rifampin | Drug | Orelabrutinib + Rifampin |
| Orelabrutinib + ItraconazoleOrelabrutinib + Itraconazole | Drug | Orelabrutinib + Itraconazole |
Primary outcome
Cmax
Time frame: up to 3 months
To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include the peak plasma concentration (Cmax)
2 secondary outcomes
Tmax
Time frame: up to 3 months
Incidence of Treatment-Emergent Adverse Events
Time frame: up to 3 months
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 6 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Orelabrutinib + Rifampin and Orelabrutinib + Itraconazole in people with Healthy Person, run by Beijing InnoCare Pharma Tech 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 8 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 6 Jul 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 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?
Cmax (time frame: up to 3 months). 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 6 Jul 2022.