Healthy VolunteerPhase 1NCT04204629
Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Subjects
A Phase 1 study testing HIP1601 40mg in people with Healthy Volunteer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition. Secondary objectives To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- HIP1601 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2020to 20 Feb 2020
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male/Female healthy volunteers in the age between 19 and 50 years old.
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
- Helicobacter pylori (H. Pylori) negative.
- After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
- Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
Who cannot join
- Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
- Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to esomeprazole or the same component or other drugs (aspirin, antibiotics, etc.).
- Blood serum aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
- Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
- Heavy smoker (>10 cigarettes/day).
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Biomedical Research Institute
Seoul
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of HIP1601 40 mg in Healthy Volunteers
Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
Secondary objectives
- To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
- Conditions
- Healthy Volunteer
- Being tested
- HIP1601 40mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP1601 40mgDrug
Also called HIP1601
Single dosing of HIP1601 40mg, PO
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601 Receives: Drug: HIP1601 40mg |
| Sequence 2 | Experimental | Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601 Receives: Drug: HIP1601 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration after dose
Measured: Blood sampling during 24 hours after administration
Area Under the plasma concentration versus time Curve(AUC)last
Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration
Measured: Blood sampling during 24 hours after administration
Integrated gastric acidity for 24-hour
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
Measured: Blood sampling during 24 hours after administration
Secondary outcomes (7)
Tmax
Time of Cmax over the time span specified
Measured: Blood sampling during 24 hours after administration
AUCinf
Area under the plasma concentration versus time curve from the time of dosing to time extrapolated to infinitely
Measured: Blood sampling during 24 hours after administration
t1/2
Terminal half-life
Measured: Blood sampling during 24 hours after administration
Clearance/F
Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf
Measured: Blood sampling during 24 hours after administration
Vd/F
Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf)
Measured: Blood sampling during 24 hours after administration
Duration of time intra-gastric pH 4.0 or higher
Percent of time with intra-gastric pH greater than 4.0 for 24-hour interval after dose
Measured: Blood sampling during 24 hours after administration
Median pH
Median intra-gastric pH for 24-hour interval after dose
Measured: Blood sampling during 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start13 Jan 2020
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD, Principal investigator, Seoul National University Hospital, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204629
- Sponsor's protocol ID
- HM-ESOM-103
- Status last verified
- Feb 2020
- First submitted
- 17 Dec 2019
- Last updated
- 1 Nov 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 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of HIP1601 40 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04204629
- Acronym / sponsor ID
- HM-ESOM-103
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 19 Dec 2019 (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.
Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
Secondary objectives
- To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: HIP1601 40mgPeriod 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601 |
| Sequence 2 | Experimental | Drug: HIP1601 40mgPeriod 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male/Female healthy volunteers in the age between 19 and 50 years old.
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
- Helicobacter pylori (H. Pylori) negative.
- After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
- Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
Key exclusion criteria (5 listed)
- Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
- Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to esomeprazole or the same component or other drugs (aspirin, antibiotics, etc.).
- Blood serum aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
- Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
- Heavy smoker (>10 cigarettes/day).
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 |
|---|---|---|
| HIP1601 40mgAlso: HIP1601Single dosing of HIP1601 40mg, PO | Drug | Sequence 1, Sequence 2 |
Primary outcome
Cmax
Time frame: Blood sampling during 24 hours after administration
Maximum observed concentration after dose
Area Under the plasma concentration versus time Curve(AUC)last
Time frame: Blood sampling during 24 hours after administration
Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration
Integrated gastric acidity for 24-hour
Time frame: Blood sampling during 24 hours after administration
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
7 secondary outcomes
Tmax
Time frame: Blood sampling during 24 hours after administration
AUCinf
Time frame: Blood sampling during 24 hours after administration
t1/2
Time frame: Blood sampling during 24 hours after administration
Clearance/F
Time frame: Blood sampling during 24 hours after administration
Vd/F
Time frame: Blood sampling during 24 hours after administration
Duration of time intra-gastric pH 4.0 or higher
Time frame: Blood sampling during 24 hours after administration
Median pH
Time frame: Blood sampling during 24 hours after administration
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 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
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.
In-Jin Jang, MD principal investigator
Seoul National University Hospital, Seoul, Korea
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 HIP1601 40mg in people with Healthy Volunteer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
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 5 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 Nov 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 South Korea. 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: Blood sampling during 24 hours after administration). 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 Nov 2022.