HealthyPhase 1NCT04485884
A Study to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 in Healthy Male Subjects
A Phase 1 study testing IN-C005 dose A, IN-C005 dose B and IN-C005 dose C in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 after oral administration in healthy Korean and Caucasian male subjects. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IN-C005 dose A, IN-C005 dose B and IN-C005 dose C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2020to Jun 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- [For single dosing group only] Healthy Korean male aged 19 to 50 years (inclusive) at the time of signing the informed consent form (ICF)
- [For multiple dosing group only] Healthy Caucasian male aged 19 to 50 years (inclusive) at the time of signing the ICF (Caucasian subject is defined as a European who was born in Europe, has the duration of residence outside of Europe less than 10 years, and both of whose parents and grandparents are European-born).
- Body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2 with a body weight ≥ 55.0 kg at screening. (BMI (kg/m2) = weight (kg) / {height (m)}2)
- Subjects with negative result in serum Helicobacter pylori antibody test.
- Voluntary participation in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure
- Subjects who are eligible for this study in the opinion of the investigator based on the results of physical examination, clinical laboratory tests, interview, etc.
Who cannot join
- History or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- History or current evidence of gastrointestinal disease that may affect the safety and PD assessment for study treatment (e.g., gastrointestinal ulcer, gastritis, gastric cramp, gastroesophageal reflux disease, and Crohn's disease) or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- History or current evidence of clinically significant hypersensitivity to drugs containing IN-C005 or any ingredient of proton pump inhibitors and other drugs (such as aspirin and antibiotics).
- Subjects with positive result on serology tests (for hepatitis B, human immunodeficiency virus [HIV], and hepatitis C).
- Subjects with blood level of total bilirubin, AST (GOT), or ALT (GPT) > 1.5 X upper limit of normal range(ULN) at procedures performed during the screening period including those performed additionally.
- Subjects with eGFR < 60 ml/min/1.73m2 during the screening period including those performed additionally.
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- Systolic blood pressure (SBP) of < 90 mmHg or > 140 mmHg, diastolic blood pressure (DBP) of < 50 mmHg or > 95 mmHg, or pulse rate of < 45 beats/min or > 100 beats/min on vital signs as measured in sitting position after taking a rest for at least 5 minutes at screening.
- Subjects with anatomical disorder that precludes insertion and maintenance of intragastric pH meter catheter or is expected to be intolerable to insertion of intragastric pH meter catheter.
- History of drug abuse or positive response to drug abuse on urine drug screening test.
- Subjects who received any prescription drug or herbal medication within 2 weeks of or any over-the-counter (OTC) drug, dietary supplements, or vitamins within 1 week of scheduled first dose or subjects who are expected to receive such medication during the study. (Note: a subject may participate in the study at the discretion of the investigator, provided that the subject meets all the other criteria).
- Subjects who participated in any other clinical study or bioequivalence study and received investigational product within 6 months prior to the scheduled first dose.
- Subjects who have donated whole blood within 2 months prior to the scheduled first dose, or have donated blood components or received transfusion within a month prior to the scheduled first dose.
- Excessive caffeine intake (> 5 units/day), continued use of alcohol (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to stop drinking while hospitalized.
- Positive result for cotinine on urine drug screening test or inability to quit smoking throughout the study.
- Subjects who have taken grapefruit-containing foods during the period from 24 hours (hrs) before hospitalization to discharge, or are unable to avoid grapefruit-containing foods during this period.
- Subjects who are unable to avoid caffeine-containing foods (e.g., coffee, tea [red tea, green tee, etc.], soda, coffee milk, and nutritive tonic drink) during the period from 24 hrs before hospitalization to discharge.
- Subjects who are unable to use medically acceptable contraceptive methods throughout the study.
- ► Medically acceptable contraceptive methods include:
- ① Use of intrauterine device with a proven birth control failure rate by the spouse (or partner);
- ② Simultaneous use of (male or female) barrier method and spermicide; and
- ③ Surgical sterilization of the subject or his partner (e.g., vasectomy, salpingectomy, tubal ligation, or hysterectomy).
- Subjects who are determined ineligible for study participation by the investigator for other reasons such as clinical laboratory abnormalities.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
About this study
Official title: An Open-label, Randomized, Single and Multiple Dosing Phase I Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 After Oral Administration in Healthy Korean and Caucasian Male Subjects
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 after oral administration in healthy Korean and Caucasian male subjects.
Read the detailed description
[Pharmacokinetic Assessments]: Plasma concentrations of IN-C005 and its metabolite will be measured
- Single Dosing Group (Korean Subjects)
- Primary endpoints: Cmax and AUClast of IN-C005
- Secondary endpoints: AUClast, Cmax, AUCinf, Tmax, t½, CL/F, and Vd/F of M1; AUCinf, Tmax, t½, CL/F, and Vd/F of IN-C005
- Multiple Dosing Group (Caucasian Subjects)
- Primary endpoints: Cmax, AUClast, Cmax,ss, and AUCτ,ss of IN-C005
- Secondary endpoints: For M1, AUClast, Cmax, Cmax,ss, AUCinf, AUCτ,ss, Tmax, Tmax,ss, t½, CL/F, and Vd/F; for IN-C005, AUCinf, Tmax, Tmax,ss, Cmin,ss, t½, CL/F, Vd/F, Cav,ss, CLss/F, Vss/F, PTF (peak to trough fluctuation), and R (accumulation ratio)
[Pharmacodynamic Assessments]:
- Single Dosing Group (Korean Subjects)
- Intragastric pH
- Percent (%) duration of pH ≥4 in 24 hrs
- Mean pH
- Median pH
- Change in pH from baseline to post-dose (Δduration %, Δmean pH, Δmedian pH, etc.)
- Serum gastrin level
- AUEGlast
- Gmax
- Change in gastrin level from baseline to study treatment (1d, 8d, and 15d)(ΔAUEGlast, ΔGmax, etc.)
- Multiple Dosing Group (Caucasian Subjects)
- Intragastric pH
- Percent (%) duration of pH ≥4 in 24 hrs
- Mean pH
- Median pH
- Change in pH from baseline to post-single dose and post-multiple doses (Δduration %, Δmean pH, Δmedian pH, etc.)
- Serum gastrin level
- AUEGlast
- Gmax
- Change in gastrin level from baseline to 1d and 7d (ΔAUEGlast, ΔGmax, etc.)
[Safety Assessments] <Single Dosing Group (Korean Subjects) and Multiple Dosing Group (Caucasian Subjects)>
- AEs will be monitored with observable/objective symptoms, etc.
- Physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests
- Conditions
- Healthy
- Being tested
- IN-C005 dose A, IN-C005 dose B, IN-C005 dose C, IN-C005 dose D, IN-C005 dose E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-C005 dose ADrug
Also called IN-C005
One time dose of IN-C005 dose A taken orally.
IN-C005 dose BDrug
Also called IN-C005
One time dose of IN-C005 dose B taken orally.
IN-C005 dose CDrug
Also called IN-C005
One time dose of IN-C005 dose C taken orally.
IN-C005 dose DDrug
Also called IN-C005
Oral administration of IN-C005 dose D once daily for 7 days.
IN-C005 dose EDrug
Also called IN-C005
Oral administration of IN-C005 dose E once daily for 7 days.
IN-C005 dose FDrug
Also called IN-C005
Oral administration of IN-C005 dose F once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | IN-C005 dose A Receives: Drug: IN-C005 dose A |
| Group B | Experimental | IN-C005 dose B Receives: Drug: IN-C005 dose B |
| Group C | Experimental | IN-C005 dose C Receives: Drug: IN-C005 dose C |
| Group D | Experimental | IN-C005 dose D Receives: Drug: IN-C005 dose D |
| Group E | Experimental | IN-C005 dose E Receives: Drug: IN-C005 dose E |
| Group F | Experimental | IN-C005 dose F Receives: Drug: IN-C005 dose F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]
Cmax of IN-C005
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]
AUClast of IN-C005
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Cmax,ss of IN-C005
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
AUCtau,ss of IN-C005
Measured: Up to 48 hours
Secondary outcomes (41)
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
AUClast of M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Cmax of M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
AUCinf of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Tmax of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
t½ of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
CL/F of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Vd/F of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
AUClast of M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Cmax of M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Cmax,ss of M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
AUCinf of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
AUCtau,ss of M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Tmax of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Tmax,ss of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
t½ of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
CL/F of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Vd/F of IN-C005 and M1
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Cmin,ss of IN-C005
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Cav,ss of IN-C005
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
CLss/F of IN-C005
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Vss/F of IN-C005
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
PTF (peak to trough fluctuation) of IN-C005
Measured: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
R (accumulation ratio) of IN-C005
Measured: Up to 48 hours
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Percent (%) duration of pH ≥ 4 in 24 hours
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Mean pH
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Median pH
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Change in pH from baseline to post-dose of Δduration %
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Change in pH from baseline to post-dose of Δmean pH
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Change in pH from baseline to post-dose of Δmedian pH
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
AUEGlast(Area under the concentration-time curve of serum gastrin from time zero to the last point of quantifiable concentration)
Measured: Up to 48 hours
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Gmax (Maximum plasma concentration of gastrin)
Measured: Up to 48 hours
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Change in gastrin level from baseline to 1d and 7d of ΔAUEGlast
Measured: Up to 48 hours
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Change in gastrin level from baseline to 1d and 7d of ΔGmax
Measured: Up to 48 hours
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Percent (%) duration of pH ≥ 4 in 24 hours
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Mean pH
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Median pH
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Change in pH from baseline to post-single dose and post-multiple dose (Δduration %, Δmean pH, Δmedian pH, etc)
Measured: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
AUEGlast(Area under the concentration-time curve of serum gastrin from time zero to the last point of quantifiable concentration)
Measured: Up to 48 hours
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]
Gmax (Maximum plasma concentration of gastrin)
Measured: Up to 48 hours
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]
Change in gastrin level from baseline to 1d and 7d of ΔAUEGlast
Measured: Up to 48 hours
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]
Change in gastrin level from baseline to 1d and 7d of ΔGmax
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start13 Aug 2020
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD, PhD, Principal investigator, Seoul National University Hospital, Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485884
- Sponsor's protocol ID
- IN_BTK_101
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single and Multiple Dosing Phase I Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 After Oral Administration in Healthy Korean and Caucasian Male Subjects
- ClinicalTrials.gov ID
- NCT04485884
- Acronym / sponsor ID
- IN_BTK_101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 24 Jul 2020 (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.
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 after oral administration in healthy Korean and Caucasian male subjects.
Detailed description
[Pharmacokinetic Assessments]: Plasma concentrations of IN-C005 and its metabolite will be measured
- Single Dosing Group (Korean Subjects)
- Primary endpoints: Cmax and AUClast of IN-C005
- Secondary endpoints: AUClast, Cmax, AUCinf, Tmax, t½, CL/F, and Vd/F of M1; AUCinf, Tmax, t½, CL/F, and Vd/F of IN-C005
- Multiple Dosing Group (Caucasian Subjects)
- Primary endpoints: Cmax, AUClast, Cmax,ss, and AUCτ,ss of IN-C005
- Secondary endpoints: For M1, AUClast, Cmax, Cmax,ss, AUCinf, AUCτ,ss, Tmax, Tmax,ss, t½, CL/F, and Vd/F; for IN-C005, AUCinf, Tmax, Tmax,ss, Cmin,ss, t½, CL/F, Vd/F, Cav,ss, CLss/F, Vss/F, PTF (peak to trough fluctuation), and R (accumulation ratio)
[Pharmacodynamic Assessments]:
- Single Dosing Group (Korean Subjects)
- Intragastric pH
- Percent (%) duration of pH ≥4 in 24 hrs
- Mean pH
- Median pH
- Change in pH from baseline to post-dose (Δduration %, Δmean pH, Δmedian pH, etc.)
- Serum gastrin level
- AUEGlast
- Gmax
- Change in gastrin level from baseline to study treatment (1d, 8d, and 15d)(ΔAUEGlast, ΔGmax, etc.)
- Multiple Dosing Group (Caucasian Subjects)
- Intragastric pH
- Percent (%) duration of pH ≥4 in 24 hrs
- Mean pH
- Median pH
- Change in pH from baseline to post-single dose and post-multiple doses (Δduration %, Δmean pH, Δmedian pH, etc.)
- Serum gastrin level
- AUEGlast
- Gmax
- Change in gastrin level from baseline to 1d and 7d (ΔAUEGlast, ΔGmax, etc.)
[Safety Assessments] <Single Dosing Group (Korean Subjects) and Multiple Dosing Group (Caucasian Subjects)>
- AEs will be monitored with observable/objective symptoms, etc.
- Physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: IN-C005 dose AIN-C005 dose A |
| Group B | Experimental | Drug: IN-C005 dose BIN-C005 dose B |
| Group C | Experimental | Drug: IN-C005 dose CIN-C005 dose C |
| Group D | Experimental | Drug: IN-C005 dose DIN-C005 dose D |
| Group E | Experimental | Drug: IN-C005 dose EIN-C005 dose E |
| Group F | Experimental | Drug: IN-C005 dose FIN-C005 dose F |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- [For single dosing group only] Healthy Korean male aged 19 to 50 years (inclusive) at the time of signing the informed consent form (ICF)
- [For multiple dosing group only] Healthy Caucasian male aged 19 to 50 years (inclusive) at the time of signing the ICF (Caucasian subject is defined as a European who was born in Europe, has the duration of residence outside of Europe less than 10 years, and both of whose parents and grandparents are European-born).
- Body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2 with a body weight ≥ 55.0 kg at screening. (BMI (kg/m2) = weight (kg) / {height (m)}2)
- Subjects with negative result in serum Helicobacter pylori antibody test.
- Voluntary participation in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure
Key exclusion criteria (22 listed)
- History or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- History or current evidence of gastrointestinal disease that may affect the safety and PD assessment for study treatment (e.g., gastrointestinal ulcer, gastritis, gastric cramp, gastroesophageal reflux disease, and Crohn's disease) or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- History or current evidence of clinically significant hypersensitivity to drugs containing IN-C005 or any ingredient of proton pump inhibitors and other drugs (such as aspirin and antibiotics).
- Subjects with positive result on serology tests (for hepatitis B, human immunodeficiency virus [HIV], and hepatitis C).
- Subjects with blood level of total bilirubin, AST (GOT), or ALT (GPT) > 1.5 X upper limit of normal range(ULN) at procedures performed during the screening period including those performed additionally.
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-C005 dose AAlso: IN-C005One time dose of IN-C005 dose A taken orally. | Drug | Group A |
| IN-C005 dose BAlso: IN-C005One time dose of IN-C005 dose B taken orally. | Drug | Group B |
| IN-C005 dose CAlso: IN-C005One time dose of IN-C005 dose C taken orally. | Drug | Group C |
| IN-C005 dose DAlso: IN-C005Oral administration of IN-C005 dose D once daily for 7 days. | Drug | Group D |
| IN-C005 dose EAlso: IN-C005Oral administration of IN-C005 dose E once daily for 7 days. | Drug | Group E |
| IN-C005 dose FAlso: IN-C005Oral administration of IN-C005 dose F once daily for 7 days. | Drug | Group F |
Primary outcome
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Cmax of IN-C005
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
AUClast of IN-C005
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Cmax,ss of IN-C005
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
AUCtau,ss of IN-C005
41 secondary outcomes
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
Time frame: Up to 48 hours
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
Time frame: Up to 48 hours
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]
Time frame: Up to 48 hours
Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]
Time frame: Up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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.
In-Jin Jang, MD, PhD principal investigator
Seoul National University Hospital, Clinical Trial Center
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 IN-C005 dose A, IN-C005 dose B and IN-C005 dose C in people with Healthy, 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 6 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 9 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youngshin Keum, R.Ph, Pharm.D (+82-2-6477-0204, ys.keum@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)] (time frame: Up to 48 hours). 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 9 Nov 2020.