Healthy SubjectPhase 1NCT05660720
Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects
A Phase 1 study testing Orelabrutinib and Moxifloxacin hydrochloride in people with Healthy Subject, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
Trial summary
This is A Randomized, Blinded, Placebo- and Positive-Controlled, Four-Period, Crossover-Design Thorough QT/QTc (TQT) Study to Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy 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 Subject
- What is being tested?
- Orelabrutinib and Moxifloxacin hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2022to 31 Aug 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
- After being informed and understanding of the trial process and possible adverse reactions of the drug, the subjects voluntarily signed an informed consent form (ICF) and confirmed their participation in all study procedures;
- Healthy subjects aged 18-45 years (inclusive) at the time of signing the informed consent;
- Weight of subjects ≥50.0 kg and ≤100.0 kg; Body mass index (BMI) ≥19.0 kg/m2 and ≤ 30.0 kg/m2, BMI= weight (kg)/height 2 (m2);
- Subjects do not have clinically meaningful medical history and various examinations including physical examination, vital signs, laboratory tests or ECG, and the results are normal or abnormal without clinical significance judged by investigators.
- Eligible fertile subjects (male and female) must agree to abstain from sex (avoid heterosexual sex) or use effective contraceptives with an annual contraceptive failure rate of less than 1% during the trial period until 3 months after the end of the trial.
Who cannot join
- History of any clinically serious disease like heart, liver, kidney, gastrointestinal tract, blood and respiratory system, immune system etc, with a history of fainting during acupuncture or injection or when seeing blood, or cannot tolerate venipuncture;
- Abnormal renal ,liver and pancreas function;
- Low blood pressure (systolic blood pressure<90 mmHg; diastolic blood pressure<60 mmHg) or hypertension (systolic blood pressure ≥ 140 mmHg; diastolic blood pressure ≥ 90 mmHg);
- Prolonged QTc interval that is at risk of causing torsade de pointes (TdP) requires drug treatment or other heart related abnormalities require drug treatment;
- The average value of three repetitions of 12 lead ECG at screening and before the first administration exceeded the standard: PR>220 ms, QRS>120 ms, HR<50 bpm, QTcF>450 ms (male and female), and any ECG abnormality with clinical significance determined by the investigator at screening;
- With a history of dysphagia or any gastrointestinal disease that affects drug absorption;
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- With a history of drug or food allergy, or a history of specific allergies (asthma, urticaria, eczema, etc.); or allergic to moxifloxacin or other fluoroquinolones;
- Within 3 months before screening, those who have undergone surgery, have smoked more than 5 cigarettes or e-cigarettes daily, with a history of drug abuse or illicit drug use, or plan to undergo surgery during the study period, or with positive results of urine drug test at screening;
- Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within 14 days before the first dose;
- People with positive results of one or more of the following tests: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), HIV antigen/antibody joint test (HIV Ab), Treponema pallidum antibody (TP Ab) and COVID-19 at screening;
- Within 1 month before screening, those who have received anticoagulant therapy or thrombin inhibitor and/or antiplatelet therapy, any drug that inhibits or induces the metabolism of a drug by the liver;
- Those who have frequently used alcohol within 6 months before screening, or those who are unable to abstain from alcohol during the study period, or those who have positive results of breath alcohol test at the time of screening;
- Within 7 days before screening those who have drunk excessive tea, coffee or caffeinated beverages, or who have eaten fruits or food that affect metabolic enzymes, within 1 months before screening who are used to beverages or food rich in xanthine ingredients, and those who are unable to abstain from such beverages, fruits or food mentioned above during the whole study period;
- Those who have participated in 4 or more clinical trials during the past one year; who have taken other study drugs or participated in other drug clinical trials within 3 months before screening;
- Those who have donated blood or plan to donate blood within 3 months before screening, or have received blood transfusion within 4 weeks before screening;
- Those who have been vaccinated within 4 weeks before screening, or plan to get vaccinated during the study period;
- Women who are pregnant or breastfeeding, or have positive results of serum human chorionic gonadotropin (HCG) test before the first dose;
- Those who disagree to discontinue strenuous exercises from the date of signing the ICF to the end of the trial (including non-hospitalization period);
- Those who cannot complete this study due to other reasons or who have clinically significant lab abnormalities as determined by the investigator, or who are not suitable for this study as assessed by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blinded, Placebo- and Positive-Controlled, Four-Period, Crossover-Design Thorough QT/QTc (TQT) Study to Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects
This is A Randomized, Blinded, Placebo- and Positive-Controlled, Four-Period, Crossover-Design Thorough QT/QTc (TQT) Study to Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects
Read the detailed description
This is a randomized, blinded, placebo- and positive-controlled, four-period, crossover clinical study. A double-blind design is used for administration of orelabrutinib tablet and placebo, and an open-label design is used for moxifloxacin hydrochloride tablet.Subjects who meet all inclusion criteria and do not meet any of the exclusion criteria are randomly assigned to one of 12 treatment sequences, and each treatment sequence includes 4 periods, with a 5-day washout period between treatment periods. The subject will complete all the visit examinations on Day 17 after the first dose, then will be discharged from the study site, and will receive telephone follow-up on Day 8 ± 2 after the last dose date. If a subject has clinically significant abnormal examination results when discharging from the study site after the last dose, on-site follow-up is essential to track the abnormal examination results, or otherwise, only telephone follow-up is required.
- Conditions
- Healthy Subject
- Being tested
- Orelabrutinib and placebo (orelabrutinib tablet simulator), Orelabrutinib, Placebo (orelabrutinib tablet simulator), Moxifloxacin hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib and placebo (orelabrutinib tablet simulator)Drug
Orelabrutinib will be administered as 3 tablets (150mg) and placebo as 5 tablets (250mg)
OrelabrutinibDrug
Orelabrutinib will be administered as 8 tablets (400mg)
Placebo (orelabrutinib tablet simulator)Drug
Placebo will be administered as 8 tablets (400mg).
Moxifloxacin hydrochlorideDrug
Moxifloxacin hydrochloride will be administered as 1 tablet (400mg)
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib tablet 150 mg (study drug) and placebo 250 mg (orelabrutinib tablet simulator) | Experimental | The subjects will be dosed once on Day1 or Day6 or Day11 or Day16 according to randomization. Receives: Drug: Orelabrutinib and placebo (orelabrutinib tablet simulator) |
| Orelabrutinib 400 mg (study drug) | Experimental | The subjects will be dosed once on Day1 or Day6 or Day11 or Day16 according to randomization. Receives: Drug: Orelabrutinib |
| Placebo 400mg (orelabrutinib tablet simulator) | Placebo comparator | The subjects will be dosed once on Day1 or Day6 or Day11 or Day16according to randomization. Receives: Drug: Placebo (orelabrutinib tablet simulator) |
| Moxifloxacin hydrochloride 400 mg | Active comparator | he subjects will be dosed once on Day1 or Day6 or Day11 or Day16 according to randomization. Receives: Drug: Moxifloxacin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected change-from-baseline QTcF interval
Extraction of Holter ECGs from 1 h pre-dose to 24 h post-dose in each period.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Secondary outcomes (20)
Change-from-baseline QTcF, PR, and QRS intervals
Extraction of Holter ECGs from 1 h pre-dose to 24 h post-dose in each period.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Change-from-baseline HR
Extraction of Holter ECGs from 1 h pre-dose to 24 h post-dose in each period.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Placebo-corrected change-from-baseline PR, and QRS intervals
Extraction of Holter ECGs from 1 h pre-dose to 24 h post-dose in each period.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Placebo-corrected change-from-baseline HR
Extraction of Holter ECGs from 1 h pre-dose to 24 h post-dose in each period.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Categorical outliers for QTcF, PR, and QRS
Extraction of Holter ECGs from 1 h pre-dose to 24 h post-dose in each period.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Categorical outliers for HR
Extraction of Holter ECGs from 1 h pre-dose to 24 h post-dose in each period.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Frequency of treatment-emergent changes of T-wave morphology and U-waves presence
Extraction of Holter ECGs from 1 h pre-dose to 24 h post-dose in each period.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Tmax of Orelabrutinib after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Cmax of Orelabrutinib after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
AUC of Orelabrutinib after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
T1/2 of Orelabrutinib after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
CL/F of Orelabrutinib after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Vz/F of Orelabrutinib after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Tmax of moxifloxacin after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Cmax of moxifloxacin after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
AUC of moxifloxacin after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
T1/2 of moxifloxacin after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
CL/F of moxifloxacin after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Vz/F of moxifloxacin after single dose
Plasma samples will be collected from all the subjects for PK analysis. For each period, venous blood will be collected within 30 min pre-dose, and 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, and 24.0 h post-dose.
Measured: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Serious adverse events (SAEs) occurring from administration of drugst to follow-up period or early withdrawal, incidence of treatment-emergent adverse events
SAE and TEAE
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start19 Nov 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
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
- NCT05660720
- Sponsor's protocol ID
- ICP-CL-00120
- Status last verified
- Dec 2022
- First submitted
- 11 Nov 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- 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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo- and Positive-Controlled, Four-Period, Crossover-Design Thorough QT/QTc (TQT) Study to Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05660720
- Acronym / sponsor ID
- ICP-CL-00120
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 21 Dec 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 Randomized, Blinded, Placebo- and Positive-Controlled, Four-Period, Crossover-Design Thorough QT/QTc (TQT) Study to Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects
Detailed description
This is a randomized, blinded, placebo- and positive-controlled, four-period, crossover clinical study. A double-blind design is used for administration of orelabrutinib tablet and placebo, and an open-label design is used for moxifloxacin hydrochloride tablet.Subjects who meet all inclusion criteria and do not meet any of the exclusion criteria are randomly assigned to one of 12 treatment sequences, and each treatment sequence includes 4 periods, with a 5-day washout period between treatment periods. The subject will complete all the visit examinations on Day 17 after the first dose, then will be discharged from the study site, and will receive telephone follow-up on Day 8 ± 2 after the last dose date. If a subject has clinically significant abnormal examination results when discharging from the study site after the last dose, on-site follow-up is essential to track the abnormal examination results, or otherwise, only telephone follow-up is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib tablet 150 mg (study drug) and placebo 250 mg (orelabrutinib tablet simulator) | Experimental | Drug: Orelabrutinib and placebo (orelabrutinib tablet simulator)The subjects will be dosed once on Day1 or Day6 or Day11 or Day16 according to randomization. |
| Orelabrutinib 400 mg (study drug) | Experimental | Drug: OrelabrutinibThe subjects will be dosed once on Day1 or Day6 or Day11 or Day16 according to randomization. |
| Placebo 400mg (orelabrutinib tablet simulator) | Placebo comparator | Drug: Placebo (orelabrutinib tablet simulator)The subjects will be dosed once on Day1 or Day6 or Day11 or Day16according to randomization. |
| Moxifloxacin hydrochloride 400 mg | Active comparator | Drug: Moxifloxacin hydrochloridehe subjects will be dosed once on Day1 or Day6 or Day11 or Day16 according to randomization. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- After being informed and understanding of the trial process and possible adverse reactions of the drug, the subjects voluntarily signed an informed consent form (ICF) and confirmed their participation in all study procedures;
- Healthy subjects aged 18-45 years (inclusive) at the time of signing the informed consent;
- Weight of subjects ≥50.0 kg and ≤100.0 kg; Body mass index (BMI) ≥19.0 kg/m2 and ≤ 30.0 kg/m2, BMI= weight (kg)/height 2 (m2);
- Subjects do not have clinically meaningful medical history and various examinations including physical examination, vital signs, laboratory tests or ECG, and the results are normal or abnormal without clinical significance judged by investigators.
- Eligible fertile subjects (male and female) must agree to abstain from sex (avoid heterosexual sex) or use effective contraceptives with an annual contraceptive failure rate of less than 1% during the trial period until 3 months after the end of the trial.
Key exclusion criteria (19 listed)
- History of any clinically serious disease like heart, liver, kidney, gastrointestinal tract, blood and respiratory system, immune system etc, with a history of fainting during acupuncture or injection or when seeing blood, or cannot tolerate venipuncture;
- Abnormal renal ,liver and pancreas function;
- Low blood pressure (systolic blood pressure<90 mmHg; diastolic blood pressure<60 mmHg) or hypertension (systolic blood pressure ≥ 140 mmHg; diastolic blood pressure ≥ 90 mmHg);
- Prolonged QTc interval that is at risk of causing torsade de pointes (TdP) requires drug treatment or other heart related abnormalities require drug treatment;
- The average value of three repetitions of 12 lead ECG at screening and before the first administration exceeded the standard: PR>220 ms, QRS>120 ms, HR<50 bpm, QTcF>450 ms (male and female), and any ECG abnormality with clinical significance determined by the investigator at screening;
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 and placebo (orelabrutinib tablet simulator)Orelabrutinib will be administered as 3 tablets (150mg) and placebo as 5 tablets (250mg) | Drug | Orelabrutinib tablet 150 mg (study drug) and placebo 250 mg (orelabrutinib tablet simulator) |
| OrelabrutinibOrelabrutinib will be administered as 8 tablets (400mg) | Drug | Orelabrutinib 400 mg (study drug) |
| Placebo (orelabrutinib tablet simulator)Placebo will be administered as 8 tablets (400mg). | Drug | Placebo 400mg (orelabrutinib tablet simulator) |
| Moxifloxacin hydrochlorideMoxifloxacin hydrochloride will be administered as 1 tablet (400mg) | Drug | Moxifloxacin hydrochloride 400 mg |
Primary outcome
Placebo-corrected change-from-baseline QTcF interval
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Extraction of Holter ECGs from 1 h pre-dose to 24 h post-dose in each period.
20 secondary outcomes
Change-from-baseline QTcF, PR, and QRS intervals
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Change-from-baseline HR
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Placebo-corrected change-from-baseline PR, and QRS intervals
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Placebo-corrected change-from-baseline HR
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Categorical outliers for QTcF, PR, and QRS
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Categorical outliers for HR
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Frequency of treatment-emergent changes of T-wave morphology and U-waves presence
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Tmax of Orelabrutinib after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Cmax of Orelabrutinib after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
AUC of Orelabrutinib after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
T1/2 of Orelabrutinib after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
CL/F of Orelabrutinib after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Vz/F of Orelabrutinib after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Tmax of moxifloxacin after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Cmax of moxifloxacin after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
AUC of moxifloxacin after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
T1/2 of moxifloxacin after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
CL/F of moxifloxacin after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Vz/F of moxifloxacin after single dose
Time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17
Serious adverse events (SAEs) occurring from administration of drugst to follow-up period or early withdrawal, incidence of treatment-emergent adverse events
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- 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.
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 and Moxifloxacin hydrochloride in people with Healthy Subject, 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 5 inclusion and 19 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 21 Dec 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. Some participants in this study may receive a placebo. 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?
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?
Placebo-corrected change-from-baseline QTcF interval (time frame: Day1, Day2, Day6, Day7, Day11, Day12, Day16 and Day17). 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 21 Dec 2022.