Intrahepatic CholangiocarcinomaPhase 1NCT05930119
HMPL-453 Food Effect and PPI Study in Healthy Volunteer Study
A Phase 1 study testing HMPL-453 and Rabeprazole in people with Intrahepatic Cholangiocarcinoma, run by Hutchmed at 1 site in China.
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-453 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
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- HMPL-453 and Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2023to 28 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have fully understood the study and voluntarily signed the informed consent form;
- 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. Male need≥50 kg，famele need≥45 kg.
- Female with fertility agree to adopt efficient contraceptive measures within 6 months after signing ICF until the end of the last HMPL-453 dosing, and agree not to donate eggs (or oocytes) for reproductive purposes during this period. Acceptable and efficient contraceptive methods include complete abstinence, bilateral tubal ligation, oral or injection contraceptives, intrauterine devices, or partner vas deferens ligation. All hormonal contraception measures must be combined with barrier measures such as the use of condoms by spouses. More information can be found in Attachment 12.3 [Definition of Women with Fertility (WOCBP) and Acceptable and Unacceptable Contraceptive Methods].
- Male patients is willing to take contraception measures (during the study and for 3 months after the end of study treatment). Male patients should avoid donating or freezing sperm during this period.
- The volunteer is willing and able to comply with all aspects of the protocol.
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).
- 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 diastolic blood pressure >90mmHg.
- Currently keratopathy confirmed by ophthalmological examination, including but not limited to bullae keratopathy, zonal corneal degenerations, corneal abrasion, corneal ulcer, and sclerokeratitis.
- Current or prior history of retinal detachment.
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- 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.
- Volunteers who smoke more than 10 cigarettes per day within the first 3 months of screening and are unable to completely quit smoking during the study period.
- Volunteers who frequently drink alcohol within the first 6 months before screening, drink more than 14 units of alcohol per week。
- The volunteer has a history of drug misuse within 6 months prior to screening (including those who have tested positive for morphine, methylenedioxymethamphetamine, methamphetamine, tetrahydrocannabinol acid, ketamine, cocaine, 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), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
- The volunteer has a clinically significant X-ray,
- 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.
- The volunteer has used CYP3A strong inducer or strong inhibitor, 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 has consumed alcohol, grapefruit, lime, and caffeine within 72 hours prior to the first dose.
- Taking drugs or dietary supplements (such as calcium, phosphorus, vitamin D, parathyroid hormone, etc.) that may cause blood phosphorus and/or blood calcium to rise within 2 weeks prior to the start of the study treatment.
- 18.Needle sickness, blood sickness or difficulty in collecting venous blood. 19.The volunteer is allergic to any of the study drugs (or its excipients) to be given in this study.
- 20.A female participant is pregnant, lactating, or breastfeeding. 21.Any other medical condition judged by the investigator would make the patients unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
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-453 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-453 in Healthy Volunteers
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- HMPL-453, Rabeprazole
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-453Drug
300 mg HMPL-453
RabeprazoleDrug
20 mg of rabeprazole will be administered by mouth once daily.
| Study group | Role | What they receive |
|---|---|---|
| fast overnight | Experimental | Subjects in treatment A will administered HMPL-453 at fast overnight condition. Receives: Drug: HMPL-453 |
| high-fat meal | Experimental | Subjects in treatment B will administered HMPL-453 at high-fat meal condition. Receives: Drug: HMPL-453 |
| low-fat meal | Experimental | Subjects in treatment C will administered HMPL-453 at low-fat meal condition. Receives: Drug: HMPL-453 |
| rabeprazole | Experimental | Subjects in treatment D will administered rabeprazole combined with HMPL-453 at low-fat meal condition hour prior to receiving a standardized low-fat meal. Receives: Drug: HMPL-453; Drug: Rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter for HMPL-453: AUC0-t
Area under the concentration time curve from time 0 to the last measurable concentration
Measured: Day 1 to Day 33
PK parameter for HMPL-453: AUC0-inf
Area under the concentration time curve from time 0 extrapolated to infinity
Measured: Day 1 to Day 33
PK parameter for HMPL-453: Cmax
Maximum observed plasma concentration
Measured: Day 1 to Day 33
Secondary outcomes (2)
Assessment of safety procedures findings
Any untoward medical occurrence associated with the study drug
Measured: Day 1 to Day 33
PK parameter for HMPL-453: tmax,t1/2
Time to reach the maximum observed plasma concentration, elimination half-life
Measured: Day 1 to Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start17 Mar 2023
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label, 4-Period, Randomized 6-Sequence Study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930119
- Sponsor's protocol ID
- 2023-453-00CH1
- Status last verified
- Aug 2023
- First submitted
- 22 May 2023
- Last updated
- 6 Sep 2023
- 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-453 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05930119
- Acronym / sponsor ID
- 2023-453-00CH1
- Conditions
- Intrahepatic Cholangiocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 5 Jul 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, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-453 in Healthy Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open-label, 4-Period, Randomized 6-Sequence Study
| Arm | Type | Receives |
|---|---|---|
| fast overnight | Experimental | Drug: HMPL-453Subjects in treatment A will administered HMPL-453 at fast overnight condition. |
| high-fat meal | Experimental | Drug: HMPL-453Subjects in treatment B will administered HMPL-453 at high-fat meal condition. |
| low-fat meal | Experimental | Drug: HMPL-453Subjects in treatment C will administered HMPL-453 at low-fat meal condition. |
| rabeprazole | Experimental | Drug: HMPL-453, Drug: RabeprazoleSubjects in treatment D will administered rabeprazole combined with HMPL-453 at low-fat meal condition hour prior to receiving a standardized low-fat meal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have fully understood the study and voluntarily signed the informed consent form;
- 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. Male need≥50 kg，famele need≥45 kg.
- Female with fertility agree to adopt efficient contraceptive measures within 6 months after signing ICF until the end of the last HMPL-453 dosing, and agree not to donate eggs (or oocytes) for reproductive purposes during this period. Acceptable and efficient contraceptive methods include complete abstinence, bilateral tubal ligation, oral or injection contraceptives, intrauterine devices, or partner vas deferens ligation. All hormonal contraception measures must be combined with barrier measures such as the use of condoms by spouses. More information can be found in Attachment 12.3 [Definition of Women with Fertility (WOCBP) and Acceptable and Unacceptable Contraceptive Methods].
- Male patients is willing to take contraception measures (during the study and for 3 months after the end of study treatment). Male patients should avoid donating or freezing sperm during this period.
Key exclusion criteria (18 listed)
- 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).
- 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 diastolic blood pressure >90mmHg.
- Currently keratopathy confirmed by ophthalmological examination, including but not limited to bullae keratopathy, zonal corneal degenerations, corneal abrasion, corneal ulcer, and sclerokeratitis.
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-453300 mg HMPL-453 | Drug | fast overnight, high-fat meal, low-fat meal, rabeprazole |
| Rabeprazole20 mg of rabeprazole will be administered by mouth once daily. | Drug | rabeprazole |
Primary outcome
PK parameter for HMPL-453: AUC0-t
Time frame: Day 1 to Day 33
Area under the concentration time curve from time 0 to the last measurable concentration
PK parameter for HMPL-453: AUC0-inf
Time frame: Day 1 to Day 33
Area under the concentration time curve from time 0 extrapolated to infinity
PK parameter for HMPL-453: Cmax
Time frame: Day 1 to Day 33
Maximum observed plasma concentration
2 secondary outcomes
Assessment of safety procedures findings
Time frame: Day 1 to Day 33
PK parameter for HMPL-453: tmax,t1/2
Time frame: Day 1 to Day 33
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 Sep 2023.
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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-453 and Rabeprazole in people with Intrahepatic Cholangiocarcinoma, run by Hutchmed 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 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 6 Sep 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 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?
PK parameter for HMPL-453: AUC0-t (time frame: Day 1 to Day 33). 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 6 Sep 2023.