Healthy VolunteersPhase 1NCT06246695
A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers
A Phase 1 study testing Jaktinib Hydrochloride Tablets, Itraconazole capsule and Rifampicin Capsules in people with Healthy Volunteers, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Jaktinib Hydrochloride Tablets, Itraconazole capsule and Rifampicin Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2021to 12 Jan 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
- Healthy Volunteers aged between 18 and 45 years old;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28);
- The participant is in good health and has no history of heart, liver, kidney, digestive tract, nervous system, etc.;
Who cannot join
- The participant were deemed unsuitable for participating in the study by the investigator for any reason.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
About this study
The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Jaktinib Hydrochloride Tablets, Itraconazole capsule, Rifampicin Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaktinib Hydrochloride TabletsDrug
Also called Jaktinib
Oral Jaktinib 100 mg for 1 day
Itraconazole capsuleDrug
Also called Itraconazole
Oral Itraconazole 200 mg for 9 day
Rifampicin CapsulesDrug
Also called Rifampicin
Oral Rifampicin 600 mg for 11 day
| Study group | Role | What they receive |
|---|---|---|
| Inhibitor group | Experimental | Jaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day. Receives: Drug: Jaktinib Hydrochloride Tablets; Drug: Itraconazole capsule |
| Inducer group | Experimental | 1. Jaktinib 100mg, once daily on the 1st and 12th days before meal, Rifampicin 600mg, once daily from the 4th day to the 14th day.
2. Rifampicin 600mg, once daily from the 1th day to the 11th day, Jaktinib 100mg, once daily on the 9st and 25th days before meal. Receives: Drug: Jaktinib Hydrochloride Tablets; Drug: Rifampicin Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration
Measured: Up to 32 Days
AUC
Area under the plasma concentration versus time curve (AUC) of Jaktinib
Measured: Up to 32 Days
Adverse Events
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
Measured: Up to 32 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start27 Oct 2021
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246695
- Sponsor's protocol ID
- ZGJAK022
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06246695
- Acronym / sponsor ID
- ZGJAK022
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 7 Feb 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 primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhibitor group | Experimental | Drug: Jaktinib Hydrochloride Tablets, Drug: Itraconazole capsuleJaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day. |
| Inducer group | Experimental | Drug: Jaktinib Hydrochloride Tablets, Drug: Rifampicin Capsules1. Jaktinib 100mg, once daily on the 1st and 12th days before meal, Rifampicin 600mg, once daily from the 4th day to the 14th day. 2. Rifampicin 600mg, once daily from the 1th day to the 11th day, Jaktinib 100mg, once daily on the 9st and 25th days before meal. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Volunteers aged between 18 and 45 years old;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28);
- The participant is in good health and has no history of heart, liver, kidney, digestive tract, nervous system, etc.;
Key exclusion criteria (1 listed)
- The participant were deemed unsuitable for participating in the study by the investigator for any reason.
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 |
|---|---|---|
| Jaktinib Hydrochloride TabletsAlso: JaktinibOral Jaktinib 100 mg for 1 day | Drug | Inducer group, Inhibitor group |
| Itraconazole capsuleAlso: ItraconazoleOral Itraconazole 200 mg for 9 day | Drug | Inhibitor group |
| Rifampicin CapsulesAlso: RifampicinOral Rifampicin 600 mg for 11 day | Drug | Inducer group |
Primary outcome
Cmax
Time frame: Up to 32 Days
Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration
AUC
Time frame: Up to 32 Days
Area under the plasma concentration versus time curve (AUC) of Jaktinib
Adverse Events
Time frame: Up to 32 Days
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
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 7 Feb 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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 Jaktinib Hydrochloride Tablets, Itraconazole capsule and Rifampicin Capsules in people with Healthy Volunteers, run by Suzhou Zelgen Biopharmaceuticals 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 3 inclusion and 1 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 7 Feb 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?
Cmax (time frame: Up to 32 Days). The study lists 3 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 7 Feb 2024.