ObesityPhase 1NCT02819934
A Phase I Study to Investigate the ADME of KD101
A Phase 1 study testing KD101 in people with Obesity, run by Seoul National University Hospital.
Trial summary
A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- KD101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2016to 15 Dec 2018
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are able to provide written informed consent
- The subject is a healthy Korean aged 20 to 55 years, inclusive.
- The subject weighs at least 55 and has a body mass index (BMI)over 27
Who cannot join
- Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
- Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
- Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
- Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)
- Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product
- Subject who have history of allergy.
Show all 11Show fewer
- Subject who can not continue proper contraception method during study period.
- Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period
- Subjects who are unable to abstain from smoking during the PK/PD testing period
- Subjects who are unable to abstain from grapefruit or caffeine containing food 1 day prior the first administration of the investigational product
- Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.
About this study
Official title: A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects
A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects
Read the detailed description
A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects
- Conditions
- Obesity
- Being tested
- KD101
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD101Drug
after 10 min KD101 administered, 14C KD101 3.52ug/1ml administrated. both of them will be administrate for oral
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | experimental group Receives: Drug: KD101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity at feces,urine,blood to measure total recovery rate
radioactivity in nCi
Measured: 13day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start20 May 2016
- Primary completion6 Jun 2016
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819934
- Sponsor's protocol ID
- KD101_hAME
- Status last verified
- Mar 2020
- First submitted
- 30 May 2016
- Last updated
- 19 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. 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 of KD101 in Male Subjects
- ClinicalTrials.gov ID
- NCT02819934
- Acronym / sponsor ID
- KD101_hAME
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 May 2016 (actual)
- Primary completion
- 6 Jun 2016 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 30 Jun 2016 (estimated)
- 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 I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects
Detailed description
A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: KD101experimental group |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Are able to provide written informed consent
- The subject is a healthy Korean aged 20 to 55 years, inclusive.
- The subject weighs at least 55 and has a body mass index (BMI)over 27
Key exclusion criteria (11 listed)
- Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
- Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
- Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
- Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)
- Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product
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 |
|---|---|---|
| KD101after 10 min KD101 administered, 14C KD101 3.52ug/1ml administrated. both of them will be administrate for oral | Drug | Arm1 |
Primary outcome
Total radioactivity at feces,urine,blood to measure total recovery rate
Time frame: 13day
radioactivity in nCi
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 19 Mar 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KD101 in people with Obesity, run by Seoul National University Hospital.
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 3 inclusion and 11 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 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 at feces,urine,blood to measure total recovery rate (time frame: 13day). 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 19 Mar 2020.