ConstipationPhase 1NCT03381703
Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852
A Phase 1 study testing YH12852 and 14C-labeled YH12852 in people with Constipation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- YH12852 and 14C-labeled YH12852
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2017to 29 Mar 2017
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study
- Healthy adult, 19 - 55 of age (inclusive)
- Subjects weighing over 55 kg (inclusive) with BMI between 18 and 25 (inclusive) at screening visit
- Subjects with no clinically significant abnormal findings as determined by physical examination, ECG, medical history, or clinical laboratory test results
Who cannot join
- History of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- History of (or suspected at screening visit) disease listed below Myocardial infarction Cerebral infarction/Stroke Arrythmia that need medical treatment Unstable angina Pulmonary hypertension
- Subjects who are positive for Hepatitis B, Hepatitis C, and HIV
- History of relevant allergy/hypersensitivity
- Subjects who took prescribed medications within 14 days or over-the-counter (OTC) medications within 7 days prior to the first dose of the study drug
Show all 14Show fewer
- Subjects who have been consuming over 21 unit(1 unit = 10 g of alcohol) per week of alcohol prior to the study initiation or who is not able to stop consuming alcohol throughout the hospitalization period
- Subjects who consumed products listed below within 2 days prior to the first dose of the study drug or who is not able to stop consuming products listed below until the last site visit Foods and/or beverages containing grapefruit Products containing caffeine (Coffee, tea, chocolate, caffeine-containing soft drinks)
- Subject who is not willing to use contraception throughout the study
- Subjects who have smoked over 10 cigarettes until 3 months prior to the study initiation or who is not able to stop smoking throughout the hospitalization period
- Subjects who have donated whole blood within 2 months or blood component within 1 month or received blood transfusion within 1 month of participating in this study
- Administration of any investigational products within 3 months from the first dose of the study drug
- Subject who's serum prolactin is over 3-fold higher than the upper limit of normal range
- Subject who judged not eligible for study participation by investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul
About this study
Official title: A Phase I Study to Investigate the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852 in Healthy Male Subjects
This study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects
Read the detailed description
Part 1 : Investigate the absorption metabolism, and excretion of YH12852 after single oral administration of YH12852 and 14C-labeled YH12852.
Part 2
: Investigate the absolute bioavailability of YH12852 after single oral administration of YH12852 followed by a single i.v. administration of 14C-labeled YH12852.
- Conditions
- Constipation
- Being tested
- YH12852, 14C-labeled YH12852
- Keywords
- Accelerated Mass Spectrometry, Microtracer, Microdose, hAME, Absolute bioavailability
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH12852Drug
YH12852 administration
14C-labeled YH12852Drug
14C-labeled YH12852 administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Investigate the absorption, metabolism, and excretion of YH12852 Receives: Drug: YH12852; Drug: 14C-labeled YH12852 |
| Part 2 | Experimental | Investigate the absolute bioavailability of YH12852 Receives: Drug: YH12852; Drug: 14C-labeled YH12852 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity
Total radioactivity recovered
Measured: 0 - 288 hours (post-dose)
Cmax of YH12852
Peak concentration of YH12852
Measured: 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)
AUClast of YH12852
Area under the concentration-time curve from time 0 to the last measurable time of YH12852
Measured: 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)
Fpo of YH12852
Oral bioavailability of YH12852
Measured: 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)
Secondary outcomes (2)
Aef of YH12852
Amount excreted in feces of YH12852
Measured: 0 - 288 hours (post-dose)
Aeu of YH12852
Amount excreted in urine of YH12852
Measured: 0 - 288 hours (post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start16 Mar 2017
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Lee, MD., PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381703
- Sponsor's protocol ID
- YH12852-103(I)
- Status last verified
- May 2016
- First submitted
- 29 Oct 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03381703
- Acronym / sponsor ID
- YH12852-103(I)
- Conditions
- Constipation
- Keywords
- Accelerated Mass Spectrometry, Microtracer, Microdose, hAME, Absolute bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 22 Dec 2017 (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.
This study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects
Detailed description
Part 1 : Investigate the absorption metabolism, and excretion of YH12852 after single oral administration of YH12852 and 14C-labeled YH12852.
Part 2
: Investigate the absolute bioavailability of YH12852 after single oral administration of YH12852 followed by a single i.v. administration of 14C-labeled YH12852.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: YH12852, Drug: 14C-labeled YH12852Investigate the absorption, metabolism, and excretion of YH12852 |
| Part 2 | Experimental | Drug: YH12852, Drug: 14C-labeled YH12852Investigate the absolute bioavailability of YH12852 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study
- Healthy adult, 19 - 55 of age (inclusive)
- Subjects weighing over 55 kg (inclusive) with BMI between 18 and 25 (inclusive) at screening visit
- Subjects with no clinically significant abnormal findings as determined by physical examination, ECG, medical history, or clinical laboratory test results
Key exclusion criteria (14 listed)
- History of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- History of (or suspected at screening visit) disease listed below Myocardial infarction Cerebral infarction/Stroke Arrythmia that need medical treatment Unstable angina Pulmonary hypertension
- Subjects who are positive for Hepatitis B, Hepatitis C, and HIV
- History of relevant allergy/hypersensitivity
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 |
|---|---|---|
| YH12852YH12852 administration | Drug | Part 1, Part 2 |
| 14C-labeled YH1285214C-labeled YH12852 administration | Drug | Part 1, Part 2 |
Primary outcome
Total radioactivity
Time frame: 0 - 288 hours (post-dose)
Total radioactivity recovered
Cmax of YH12852
Time frame: 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)
Peak concentration of YH12852
AUClast of YH12852
Time frame: 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)
Area under the concentration-time curve from time 0 to the last measurable time of YH12852
Fpo of YH12852
Time frame: 0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)
Oral bioavailability of YH12852
2 secondary outcomes
Aef of YH12852
Time frame: 0 - 288 hours (post-dose)
Aeu of YH12852
Time frame: 0 - 288 hours (post-dose)
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 22 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
Howard Lee, MD., PhD principal investigator
Seoul National University Hospital
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 YH12852 and 14C-labeled YH12852 in people with Constipation, run by Seoul National University Hospital 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 4 inclusion and 14 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 22 Dec 2017. 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?
Total radioactivity (time frame: 0 - 288 hours (post-dose)). 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?
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 22 Dec 2017.