Chronic Idiopathic ConstipationPhase 1NCT06736912
This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of IN-114199 in Healthy Participants
A Phase 1 study of Chronic Idiopathic Constipation, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants Read more about this study
- Who is it for?
- Ages 19 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Idiopathic Constipation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Dec 2024to 11 Nov 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged ≥ 19 years and ≤ 63 years on the date of the written informed consent
- Healthy subjects were defined as individuals who defecated almost every day for ≥ 6 months
- Body weight of ≥ 40.0 kg and ≤ 100.0 kg, with body mass index (BMI) of ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2 at the time of screening
- Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.
- Those who are judged eligible for this study upon judgment of the investigator in screening tests established depending on the characteristics of investigational product (examinations by interview, clinical laboratory test, physical examinations, etc.).
Who cannot join
- Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
- Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
- Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
- Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- Subjects who have history of drug abuse, or who have a positive urine test for drugs of abuse.
- Blood AST(SGOT), and ALT(SGPT) > 60 IU/L at the screening test
Show all 14Show fewer
- Showing the following findings on ECG at the screening test: QT > 480 msec(all), QTcB>450(male), QTcB>470(female)
- Subjects who have taken any drugs known to significantly induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 1 month prior to the expected initial application date.
- Subjects who have participated in other clinical trials within 6 months prior to the expected initial application date
- Subjects who have history of regular alcohol consumption exceeding 21 units/week (1 unit = 10 g = 12.5 mL of pure alcohol) or subjects who cannot avoid drinking alcohol from 3 days prior to the expected initial application date to the discharge
- Subjects who have history of average use of 10 cigarettes daily
- Subjects who consumed caffeine-containing food (coffee, green tea, black tea, carbonated beverage, coffee-flavored milk, tonics, etc.) or subjects who cannot avoid drinking caffeine-containing food from 3 days prior to the expected initial application date to the discharge
- Subjects are unable to use a highly effective method of contraception (e.g., correctly placed intrauterine device(IUD), sterilization surgery (vasectomy, tubal ligation, etc.))
- Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital, Clinical Trial Center
Seoul
Seung Hwan Lee, MD, PhD, +82-2-2072-2343, leejh413@snu.ac.kr
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single/multiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety/tolerability, Pharmacokinetic/pharmacodynamic Characteristics and Food Effect After Oral Administration of IN-114199 in Healthy Participants
This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants
Read the detailed description
Part A: SAD and FES study
- To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults
- To compare and evaluate the effects of food on the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults
Part B: MAD study
- To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of repeated oral doses of IN-114199 in healthy adults
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- IN-114199 2.5mg or placebo, IN-114199 10mg or placebo, IN-114199 20mg or placebo, IN-114199 40mg or placebo, IN-114199 5mg or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-114199 2.5mg or placeboDrug
IN-114199 2.5mg or placebo (1 Tablet, QD)
IN-114199 10mg or placeboDrug
IN-114199 10mg or placebo (1 Tablet, QD)
IN-114199 20mg or placeboDrug
IN-114199 10mg or placebo (2 Tablets, QD)
IN-114199 40mg or placeboDrug
IN-114199 10mg or placebo (4 Tablets, QD)
IN-114199 5mg or placeboDrug
IN-114199 2.5mg or placebo (2 Tablets, QD)
| Study group | Role | What they receive |
|---|---|---|
| Part I(Cohort I) IN-114199 2.5 mg or Placebo | Experimental | SAD Receives: Drug: IN-114199 2.5mg or placebo |
| Part I(Cohort 2) IN-114199 5 mg or Placebo | Experimental | SAD and FES Receives: Drug: IN-114199 5mg or placebo |
| Part I(Cohort 3) IN-114199 10 mg or Placebo | Experimental | SAD and FES Receives: Drug: IN-114199 10mg or placebo |
| Part I(Cohort 4) IN-114199 20 mg or Placebo | Experimental | SAD and FES Receives: Drug: IN-114199 20mg or placebo |
| Part I(Cohort 5) IN-114199 40 mg or Placebo | Experimental | SAD Receives: Drug: IN-114199 40mg or placebo |
| Part II(Cohort I) IN-114199 2.5 mg or Placebo | Experimental | MAD Receives: Drug: IN-114199 2.5mg or placebo |
| Part II(Cohort 2) IN-114199 5 mg or Placebo | Experimental | MAD Receives: Drug: IN-114199 5mg or placebo |
| Part II(Cohort 3) IN-114199 10 mg or Placebo | Experimental | MAD Receives: Drug: IN-114199 10mg or placebo |
| Part II(Cohort 4) IN-114199 20 mg or Placebo | Experimental | MAD Receives: Drug: IN-114199 20mg or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship
Measured: Up to Post Study Visit (Part I SAD: Day 7~Day 9/ Part I SAD, FES: Day 14~ Day 16/ Part II:Day 13~Day 15)
Vital Sign
Vital sign results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Measured: Part I : Up to Day 3/ Part II: Up to Day 9
Physical Examination
Physical examination results will be classified as normal, not clinically significant, or clinically significant upon a judgment of the investigator after single/multiple dosing of IN-114199.
Measured: Part I : Up to Day 3/ Part II: Up to Day 9
Body Weight in kilograms Measurement
The body weight in kilograms of Subjects will be monitored daily from the administration of IN-114199 until their discharge
Measured: Part I : Up to Day 3 / Part II: Up to Day 9
12-lead electrocardiogram (ECG)
QT/QTc interval will be recorded and analyzed automatically.
Measured: Part I SAD: Up to Day 3 / Part II: Up to Day 9
Clinical Laboratory Test
Clinical laboratory test, the results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Measured: Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9
Secondary outcomes (4)
PK parameters (Urine and Plasma)
Cmax
Measured: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
PK parameters (Urine and Plasma)
AUClast
Measured: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
PD parameters (plasma C4 level)
AUEClast
Measured: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
PD parameters (plasma LDL/HDL level)
AUEClast
Measured: Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start16 Dec 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion11 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic ConstipationStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736912
- Sponsor's protocol ID
- IN_IBA_102
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single/multiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety/tolerability, Pharmacokinetic/pharmacodynamic Characteristics and Food Effect After Oral Administration of IN-114199 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06736912
- Acronym / sponsor ID
- IN_IBA_102
- Conditions
- Chronic Idiopathic Constipation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 11 Nov 2025 (estimated)
- First posted
- 17 Dec 2024 (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 aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants
Detailed description
Part A: SAD and FES study
- To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults
- To compare and evaluate the effects of food on the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults
Part B: MAD study
- To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of repeated oral doses of IN-114199 in healthy adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part I(Cohort I) IN-114199 2.5 mg or Placebo | Experimental | Drug: IN-114199 2.5mg or placeboSAD |
| Part I(Cohort 2) IN-114199 5 mg or Placebo | Experimental | Drug: IN-114199 5mg or placeboSAD and FES |
| Part I(Cohort 3) IN-114199 10 mg or Placebo | Experimental | Drug: IN-114199 10mg or placeboSAD and FES |
| Part I(Cohort 4) IN-114199 20 mg or Placebo | Experimental | Drug: IN-114199 20mg or placeboSAD and FES |
| Part I(Cohort 5) IN-114199 40 mg or Placebo | Experimental | Drug: IN-114199 40mg or placeboSAD |
| Part II(Cohort I) IN-114199 2.5 mg or Placebo | Experimental | Drug: IN-114199 2.5mg or placeboMAD |
| Part II(Cohort 2) IN-114199 5 mg or Placebo | Experimental | Drug: IN-114199 5mg or placeboMAD |
| Part II(Cohort 3) IN-114199 10 mg or Placebo | Experimental | Drug: IN-114199 10mg or placeboMAD |
| Part II(Cohort 4) IN-114199 20 mg or Placebo | Experimental | Drug: IN-114199 20mg or placeboMAD |
Who may qualify
- Ages
- 19 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults aged ≥ 19 years and ≤ 63 years on the date of the written informed consent
- Healthy subjects were defined as individuals who defecated almost every day for ≥ 6 months
- Body weight of ≥ 40.0 kg and ≤ 100.0 kg, with body mass index (BMI) of ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2 at the time of screening
- Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.
- Those who are judged eligible for this study upon judgment of the investigator in screening tests established depending on the characteristics of investigational product (examinations by interview, clinical laboratory test, physical examinations, etc.).
Key exclusion criteria (14 listed)
- Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
- Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
- Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
- Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- Subjects who have history of drug abuse, or who have a positive urine test for drugs of abuse.
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 |
|---|---|---|
| IN-114199 2.5mg or placeboIN-114199 2.5mg or placebo (1 Tablet, QD) | Drug | Part I(Cohort I) IN-114199 2.5 mg or Placebo, Part II(Cohort I) IN-114199 2.5 mg or Placebo |
| IN-114199 10mg or placeboIN-114199 10mg or placebo (1 Tablet, QD) | Drug | Part I(Cohort 3) IN-114199 10 mg or Placebo, Part II(Cohort 3) IN-114199 10 mg or Placebo |
| IN-114199 20mg or placeboIN-114199 10mg or placebo (2 Tablets, QD) | Drug | Part I(Cohort 4) IN-114199 20 mg or Placebo, Part II(Cohort 4) IN-114199 20 mg or Placebo |
| IN-114199 40mg or placeboIN-114199 10mg or placebo (4 Tablets, QD) | Drug | Part I(Cohort 5) IN-114199 40 mg or Placebo |
| IN-114199 5mg or placeboIN-114199 2.5mg or placebo (2 Tablets, QD) | Drug | Part I(Cohort 2) IN-114199 5 mg or Placebo, Part II(Cohort 2) IN-114199 5 mg or Placebo |
Primary outcome
Adverse Event
Time frame: Up to Post Study Visit (Part I SAD: Day 7~Day 9/ Part I SAD, FES: Day 14~ Day 16/ Part II:Day 13~Day 15)
For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship
Vital Sign
Time frame: Part I : Up to Day 3/ Part II: Up to Day 9
Vital sign results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Physical Examination
Time frame: Part I : Up to Day 3/ Part II: Up to Day 9
Physical examination results will be classified as normal, not clinically significant, or clinically significant upon a judgment of the investigator after single/multiple dosing of IN-114199.
Body Weight in kilograms Measurement
Time frame: Part I : Up to Day 3 / Part II: Up to Day 9
The body weight in kilograms of Subjects will be monitored daily from the administration of IN-114199 until their discharge
12-lead electrocardiogram (ECG)
Time frame: Part I SAD: Up to Day 3 / Part II: Up to Day 9
QT/QTc interval will be recorded and analyzed automatically.
Clinical Laboratory Test
Time frame: Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9
Clinical laboratory test, the results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
4 secondary outcomes
PK parameters (Urine and Plasma)
Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
PK parameters (Urine and Plasma)
Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
PD parameters (plasma C4 level)
Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
PD parameters (plasma LDL/HDL level)
Time frame: Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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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.
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 of Chronic Idiopathic Constipation, run by HK inno.N Corporation 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 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: opening soon, as of the sponsor's last update on 17 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seung Hee Jung, Ph.D (+82-2-6477-0164, shee.jung@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: Up to Post Study Visit (Part I SAD: Day 7~Day 9/ Part I SAD, FES: Day 14~ Day 16/ Part II:Day 13~Day 15)). The study lists 6 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 17 Dec 2024.