Relapsed or Refractory LymphomaPhase 1NCT05720767
HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study
A Phase 1 study testing HMPL-523, Itraconazole and Rifampin in people with Relapsed or Refractory Lymphoma, run by Hutchmed at 1 site in United States.
Trial summary
A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, a CYP3A and P-glycoprotein Inhibitor, and the Effect of Rifampin, a CYP Enzyme Inducer, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsed or Refractory Lymphoma
- What is being tested?
- HMPL-523, Itraconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 5 Feb 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. The volunteer is male or female between the ages of 18 and 55 years old (inclusive) at the time of informed consent.
- 2. The volunteer has a body mass index (BMI) >18 and ≤29.9 kg/m2 at screening.
- 3. Females must be postmenopausal (defined as absence of menses for at least one year without alternative medical cause) or permanently sterile by total hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
- 4. Males, including those who have had a successful vasectomy, must use a condom during sexual intercourse with women of childbearing potential, starting from their first dose of study drug through 30 days after their last dose of study drug. Alternatively, abstinence is allowed if it is the normal and preferred lifestyle of the volunteer.
- 5. The volunteer must provide written informed consent prior to any study specific screening procedures.
- 6. The volunteer is willing and able to comply with all aspects of the protocol, as determined by the PI.
- 7. The volunteer must have normal laboratory results for total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT); creatinine clearance must be > 90 mL/min estimated using the Cockcroft-Gault equation.
Who cannot join
- 1. The volunteer has a known history of any gastrointestinal surgery or any condition possibly affecting drug absorption (eg, cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, or history of stomach or intestinal surgery or resection).
- Note: Appendectomy and hernia repairs are allowed.
- 2. The volunteer had a clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to the first dose.
- 3. The volunteer has evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations at screening or at Day -1 check-in (baseline).
- 4. The volunteer has systolic blood pressure >140 mmHg or a diastolic blood pressure >90 mmHg.
- 5. The volunteer has a clinically significant ECG abnormality, including a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTcF interval >450 msec), or had a family history of prolonged QTc syndrome or sudden death.
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- 6. The volunteer has a history of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or volunteer's verbal report and confirmed by cotinine test at check-in for each treatment period.
- 7. The volunteer has a history of drug or alcohol misuse within 6 months prior to screening or a positive urine drug test at screening or at check-in for each treatment period.
- 8. The volunteer has been diagnosed with acquired immune deficiency syndrome or has performed tests that are positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
- 9. The volunteer has participated in a clinical trial of another study drug before screening, and the time since the last use of other study drug is less than 5 times the half-life or 4 weeks, whichever is longer, or the volunteer is currently enrolled in another clinical trial.
- 10. The volunteer has consumed grapefruit, starfruit, Seville oranges, or their products within 7 days prior to the first dose.
- 11. The volunteer has consumed herbal preparations/medications, including, but not limited to, St. John's Wort, kava, ephedra (ma huang), Ginkgo biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng, within 7 days prior to the first dose (21 days for St. John's Wort).
- 12. The volunteer has experienced a weight loss or gain of >10% within 4 weeks prior to the first dose as noted by medical history and weight at screening and check-in.
- 13. The volunteer has received blood or blood products within 4 weeks, donated blood or blood products within 8 weeks prior to the first dose or donated double red cell within 16 weeks prior to first dose.
- 14. The volunteer has used any over-the-counter (OTC) medications or prescription drugs (including medications that can lower gastric acid, inhibit or induce P-gp and/or CYP3A4) within 5 half-lives of these drugs or 2 weeks prior to the first dose of study drug, whichever is longer.
- 15. The volunteer is allergic to any of the study drugs (or its excipients) to be given in this study.
- 16. A female participant is pregnant, lactating, or breastfeeding.
- 17. A male volunteer who plans to donate sperm or father a child within 30 days after receiving the study drug.
- 18. The volunteer has any condition that would make him or her, in the opinion of the PI or Sponsor, unsuitable for the study, or who, in the opinion of the PI, is not likely to complete the study for any reason.
- Note: One repeat of laboratory assessments may be performed at screening and at Check-In (Day -1) at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, and the Effect of Rifampin on the Pharmacokinetics of HMPL-523 in Healthy Volunteers
A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, a CYP3A and P-glycoprotein Inhibitor, and the Effect of Rifampin, a CYP Enzyme Inducer, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers
Read the detailed description
This study will be a single-center, open-label, 2-part, 2-period fixed-sequence crossover study to be conducted with 28 healthy male and female volunteers. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Period 1 and Period 2), and an End of Study (EOS) Phase.
- Conditions
- Relapsed or Refractory Lymphoma
- Being tested
- HMPL-523, Itraconazole, Rifampin
- Medical subject headings
- Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-523Drug
HMPL-523 is a selective small-molecule SYK inhibitor.
ItraconazoleDrug
Itraconazole is an FDA approved synthetic triazole antifungal agent
RifampinDrug
Rifampin is an FDA approved semisynthetic antiobiotic derivative indicated in the treatment of both tuberculosis and meningococcal carrier state
| Study group | Role | What they receive |
|---|---|---|
| Part A - Itraconazole | Experimental | HMPL-523 will be supplied as 100 and 150 mg tablets and will be administered PO as a single dose of 400 mg (combination of 2 of 150 mg tablets and 1 of 100 mg tablet) on two separate occasions (Day 1 and Day 10) in Part A. Itraconazole will be supplied as 100 mg capsules and will be administered as doses of 200 mg (2 × 100 mg) PO BID on Day 6 and 200 mg PO QD on Days 7 to 14 in Part A. Receives: Drug: HMPL-523; Drug: Itraconazole |
| Part B - Rifampin | Experimental | HMPL-523 will be supplied as 100 and 150 mg tablets and will be administered PO as a single dose of 700 mg (combination of 4 of 150 mg tablets and 1 of 100 mg tablet) on two separate occasions (Day 1 and Day 13) in Part B. Rifampin will be supplied as 300 mg capsules and will be administered as doses of 600 mg (2 × 300 mg) PO QD on Days 6 to 17 in Part B. Receives: Drug: HMPL-523; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter for HMPL-523: AUC0-t
Area under the plasma concentration-time curve from time 0 to time of the last measurable concentration
Measured: Day 1 to 18
PK parameter for HMPL-523: AUC0-inf
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (if data permit)
Measured: Day 1 to 18
PK parameter for HMPL-523: Cmax
Maximum observed plasma concentration
Measured: Day 1 to 18
Secondary outcomes (1)
Incidence of Adverse Events/ Serious Adverse Events
Any untoward medical occurrence associated with the study drug
Measured: Day 1 to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start4 Nov 2022
- Primary completion5 Feb 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory LymphomaStudies of the same condition, open and under way.
- More trials run by HutchmedThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720767
- Sponsor's protocol ID
- 2022-523-00US2
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, and the Effect of Rifampin on the Pharmacokinetics of HMPL-523 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05720767
- Acronym / sponsor ID
- 2022-523-00US2
- Conditions
- Relapsed or Refractory Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 5 Feb 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 9 Feb 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.
A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, a CYP3A and P-glycoprotein Inhibitor, and the Effect of Rifampin, a CYP Enzyme Inducer, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers
Detailed description
This study will be a single-center, open-label, 2-part, 2-period fixed-sequence crossover study to be conducted with 28 healthy male and female volunteers. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Period 1 and Period 2), and an End of Study (EOS) Phase.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A - Itraconazole | Experimental | Drug: HMPL-523, Drug: ItraconazoleHMPL-523 will be supplied as 100 and 150 mg tablets and will be administered PO as a single dose of 400 mg (combination of 2 of 150 mg tablets and 1 of 100 mg tablet) on two separate occasions (Day 1 and Day 10) in Part A. Itraconazole will be supplied as 100 mg capsules and will be administered as doses of 200 mg (2 × 100 mg) PO BID on Day 6 and 200 mg PO QD on Days 7 to 14 in Part A. |
| Part B - Rifampin | Experimental | Drug: HMPL-523, Drug: RifampinHMPL-523 will be supplied as 100 and 150 mg tablets and will be administered PO as a single dose of 700 mg (combination of 4 of 150 mg tablets and 1 of 100 mg tablet) on two separate occasions (Day 1 and Day 13) in Part B. Rifampin will be supplied as 300 mg capsules and will be administered as doses of 600 mg (2 × 300 mg) PO QD on Days 6 to 17 in Part B. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. The volunteer is male or female between the ages of 18 and 55 years old (inclusive) at the time of informed consent.
- 2. The volunteer has a body mass index (BMI) >18 and ≤29.9 kg/m2 at screening.
- 3. Females must be postmenopausal (defined as absence of menses for at least one year without alternative medical cause) or permanently sterile by total hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
- 4. Males, including those who have had a successful vasectomy, must use a condom during sexual intercourse with women of childbearing potential, starting from their first dose of study drug through 30 days after their last dose of study drug. Alternatively, abstinence is allowed if it is the normal and preferred lifestyle of the volunteer.
- 5. The volunteer must provide written informed consent prior to any study specific screening procedures.
Key exclusion criteria (20 listed)
- 1. The volunteer has a known history of any gastrointestinal surgery or any condition possibly affecting drug absorption (eg, cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, or history of stomach or intestinal surgery or resection).
- Note: Appendectomy and hernia repairs are allowed.
- 2. The volunteer had a clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to the first dose.
- 3. The volunteer has evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations at screening or at Day -1 check-in (baseline).
- 4. The volunteer has systolic blood pressure >140 mmHg or a diastolic blood pressure >90 mmHg.
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 |
|---|---|---|
| HMPL-523HMPL-523 is a selective small-molecule SYK inhibitor. | Drug | Part A - Itraconazole, Part B - Rifampin |
| ItraconazoleItraconazole is an FDA approved synthetic triazole antifungal agent | Drug | Part A - Itraconazole |
| RifampinRifampin is an FDA approved semisynthetic antiobiotic derivative indicated in the treatment of both tuberculosis and meningococcal carrier state | Drug | Part B - Rifampin |
Primary outcome
PK parameter for HMPL-523: AUC0-t
Time frame: Day 1 to 18
Area under the plasma concentration-time curve from time 0 to time of the last measurable concentration
PK parameter for HMPL-523: AUC0-inf
Time frame: Day 1 to 18
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (if data permit)
PK parameter for HMPL-523: Cmax
Time frame: Day 1 to 18
Maximum observed plasma concentration
1 secondary outcome
Incidence of Adverse Events/ Serious Adverse Events
Time frame: Day 1 to Day 18
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 1 Mar 2023.
- 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 HMPL-523, Itraconazole and Rifampin in people with Relapsed or Refractory Lymphoma, run by Hutchmed at 1 site in United States.
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 7 inclusion and 20 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 1 Mar 2023. 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 United States. 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?
PK parameter for HMPL-523: AUC0-t (time frame: Day 1 to 18). 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 1 Mar 2023.