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Relapsed or Refractory LymphomaPhase 1NCT05571787

HMPL-523 Food Effect and Proton Pump Inhibitor Study

A Phase 1 study testing HMPL-523 and Rabeprazole in people with Relapsed or Refractory Lymphoma, run by Hutchmed at 1 site in United States.

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

A Phase 1, Open-label, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, 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 and Rabeprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
13 Jul 2022to 22 Sep 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The volunteer is male or female between the ages of 18 and 55 years old (inclusive) at the time of informed consent.
  • The volunteer has a body mass index (BMI)>18 and ≤29.9 kg/m2at screening.
  • Females must be postmenopausal (defined as absence of menses for at least 1year without alternative medical cause)or permanently sterile by total hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
  • 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.
  • The volunteer must provide written informed consent prior to any study specific screening procedures.
  • The volunteer is willing and able to comply with all aspects of the protocol, as determined by the PI.

Who cannot join

  • 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.
  • The volunteer had a clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to the first dose.
  • 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).
  • The volunteer has systolic blood pressure >140 mmHg oradiastolic blood pressure >90mmHg.
  • The volunteer has a clinically significant ECG abnormality, including a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTcF interval >480msec), or hasa family history of prolonged QTc syndrome or sudden death.
  • 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.
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  • 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.
  • The volunteer has been diagnosed with acquired immune deficiency syndrome or has performed tests that are positive for human immunodeficiency virus (HIV), HepatitisBvirus (HBV), orHepatitis C virus (HCV).
  • The volunteer has participated in a clinical trial of other 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.1
  • The volunteer has consumed grapefruit, starfruit, Seville oranges, or their products within 7 days prior to the first dose.
  • The volunteer has consumed herbal preparations/medications, including, but not limited to, St. John's Wort, kava, ephedra (ma huang), Ginkgo biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng, within 7 days prior to the first dose (21days for St.John's Wort).
  • 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.
  • 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 16weeks prior to first dose.
  • The volunteer has used any over-the-counter (OTC) medications or prescription drugs (medications that can lower gastric acid in particular) within 2 weeks prior to the first dose.
  • The volunteer is allergic to any of the study drugs (or its excipients) to be given in this study.
  • A female participant is pregnant, lactating, or breastfeeding.
  • A male volunteer who plans to donate sperm or father a child within 30 days after receiving the study drug.
  • The volunteer has any condition that would make him or her, in the opinion of the PIor 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, including vital signs and ECG,may be performed at screening and at -check-in(Day-1) at the discretion of the PI.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PPD Austin

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Open-label, 4-period, Randomized 6-sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers

A Phase 1, Open-label, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers

Read the detailed description

This study will be a single-center, open-label, 4-period, randomized,6-sequence study conducted with 24 healthy male or female subjects. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Periods1, 2, 3,and 4), and an End of Study (EOS) Phase. Screening must occur within 28 days before the first study drug administration. There will be a washout of at least 7days between 4 administrations of HMPL-523.Subjects in Periods 1, 2, and 3 will be randomized into 1 of 6 treatment sequences, with all subjects then receiving the same treatment in Period 4.

Being tested
HMPL-523, Rabeprazole
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

    700 mg HMPL-523 will be administered by mouth once daily on Day 1, Day 8, Day 15, and Day 26

  • RabeprazoleDrug

    40 mg of rabeprazole will be administered by mouth once daily in the morning from Day 20 to Day 26

Study groups in NCT05571787
Study groupRoleWhat they receive
Treatment AExperimentalSubjects in treatment A will fast overnight for at least 10 hours prior to HMPL-523 dosing.
Receives: Drug: HMPL-523
Treatment BExperimentalSubjects in treatment B will receive a standardized high-fat meal approximately 30 minutes before HMPL-523 administration
Receives: Drug: HMPL-523
Treatment CExperimentalSubjects in treatment C will receive a standardized low-fat meal approximately 30 minutes before HMPL-523 administration
Receives: Drug: HMPL-523
Treatment DExperimentalSubjects in treatment D will receive rabeprazol 1 hour prior to receiving a standardized low-fat meal. On Day 26 subjects will also receive HMPL-523 approximately 30 minutes after the standardized low-fat breakfast
Receives: Drug: HMPL-523; Drug: Rabeprazole

What is being measured

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

  1. PK parameter for HMPL-523: AUC0-t

    Area under the concentration time curve from time 0 to the last measurable concentration

    Measured: Day 1 to Day 31

  2. PK parameter for HMPL-523: AUC0-inf

    Area under the concentration time curve from time 0 extrapolated to infinity

    Measured: Day 1 to Day 31

  3. PK parameter for HMPL-523: Cmax

    Maximum observed plasma concentration

    Measured: Day 1 to Day 31

  4. PK parameter for HMPL-523: tmax

    Time to reach the maximum observed plasma concentration

    Measured: Day 1 to Day 31

Secondary outcomes (4)

  1. Assessment of safety procedures findings

    Any untoward medical occurrence associated with the study drug

    Measured: Day 1 to Day 31

  2. PK parameter for metabolite M1: AUC0-t

    Area under the concentration time curve from time 0 to the last measurable concentration

    Measured: Day 1 to Day 31

  3. PK parameter for metabolite M1: AUC0-inf

    Area under the concentration time curve from time 0 extrapolated to infinity

    Measured: Day 1 to Day 31

  4. PK parameter for metabolite M1: Cmax

    Maximum observed plasma concentration

    Measured: Day 1 to Day 31

Timeline

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

  1. First posted7 Oct 2022
  2. Study start13 Jul 2022
  3. Primary completion22 Sep 2022
  4. Study completion22 Sep 2022

Resources

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
Crossover
Model description
Open-label, 4-Period, Randomized 6-Sequence Study
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05571787
Sponsor's protocol ID
2022-523-00US1
Status last verified
Feb 2023
First submitted
5 Oct 2022
Last updated
23 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HMPL-523 and Rabeprazole 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 6 inclusion and 18 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 23 Feb 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 Day 31). 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 NCT05571787.

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 23 Feb 2023.

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