Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate Pharmacokinetics, Safety, and Tolerability Ildong COL-144 Tablet in Korean Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937648
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief Summary:
A Randomized, Double blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate Pharmacokinetics, Safety, and Tolerability with Oral Administration of Ildong COL-144 tablet in Korean Healthy Volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: COL-144 50mg Drug: COL-144 100mg Drug: COL-144 200mg Drug: COL-144 400mg Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate Pharmacokinetics, Safety, and Tolerability With Oral Administration of Ildong COL-144 Tablet in Korean Healthy Volunteers
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: COL-144 50mg Drug: COL-144 50mg
COL-144 50mg

Experimental: COL-144 100mg Drug: COL-144 100mg
COL-144 100mg

Experimental: COL-144 200mg Drug: COL-144 200mg
COL-144 200mg

Experimental: COL-144 400mg Drug: COL-144 400mg
COL-144 400mg

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Cmax(maximum serum concentration) [ Time Frame: 0hours(predose), 0.17hours, 0.33hours, 0.5hours, 0.67hours, 1hours, 1.5hours, 2hours, 2.5hours, 3hours, 4hours, 6hours, 8hours, 12hours, Day2 0hours(24hours), 30hours, Day3 0hours(48hours), 4day 0hours(72hours) ]
  2. AUClast(rea under the curve from the time of dosing to the last measurable concentration) [ Time Frame: 0hours(predose), 0.17hours, 0.33hours, 0.5hours, 0.67hours, 1hours, 1.5hours, 2hours, 2.5hours, 3hours, 4hours, 6hours, 8hours, 12hours, Day2 0hours(24hours), 30hours, Day3 0hours(48hours), 4day 0hours(72hours) ]
  3. tmax(Time to reach maximum plasma concentration) [ Time Frame: 0hours(predose), 0.17hours, 0.33hours, 0.5hours, 0.67hours, 1hours, 1.5hours, 2hours, 2.5hours, 3hours, 4hours, 6hours, 8hours, 12hours, Day2 0hours(24hours), 30hours, Day3 0hours(48hours), 4day 0hours(72hours) ]
  4. CL/F(Clearance) [ Time Frame: 0hours(predose), 0.17hours, 0.33hours, 0.5hours, 0.67hours, 1hours, 1.5hours, 2hours, 2.5hours, 3hours, 4hours, 6hours, 8hours, 12hours, Day2 0hours(24hours), 30hours, Day3 0hours(48hours), 4day 0hours(72hours) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. A healthy adult who is at least 19 years old and less than 50 years old at the time of the screening visit.
  2. A person whose body mass index (BMI) is greater than 19 kg/m2 and less than 28 kg/m2 at the time of the screening visit.
  3. A person who is medically confirmed to be clinically insignificant in terms of a physical or mental condition by an investigator through a physical examination during the screening period.
  4. A person who has agreed to use a combination of effective contraceptive methods or medically appropriate contraceptive methods from the date of administration of the investigational product to the end of the clinical trial (date of test for final safety assessment).
  5. A male or female who has agreed not to provide sperm or eggs.
  6. A woman whose serum/urine human chorionic gonadotropin (hCG) test results were negative and who is not pregnant or breastfeeding.
  7. A person who has voluntarily decided and provided written consent to participate in clinical trials and follow precautions for test subjects.
  8. A person who can collect blood and urine during the clinical trial, including follow-up visits.

Exclusion Criteria:

  1. A person with a history of gastrointestinal disorders (ex. Crohn's disease, ulcerative colitis, etc.) or surgery (except for simple appendectomy or herniotomy) that may affect the absorption of the investigational product.
  2. In addition to Exclusion Criteria 1 above, a person with a history of clinically significant diseases related to allergy, cardiovascular system, peripheral vascular system, skin, mucous membrane, eyes, otolaryngology system, respiratory system, musculoskeletal system, infection, gastrointestinal system, liver, biliary system, endocrine system, kidney, urogenital system, nervous system, psychiatric system, blood, tumor, fracture, and others.
  3. A person with genetically caused galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
  4. A person with a history of hypersensitivity or clinically significant hypersensitivity to drugs that contain Lasmiditan or ingredients in the same category or other drugs (aspirin and non-steroidal anti-inflammatory drugs, antibiotics, etc.).
  5. A person who has a history of drug abuse or whose urine drug screening test result during the screening period came back positive for abusive drug use.
  6. A person who has donated partial or full amount of blood within 60 days of the screening visit, who has given blood through apheresis within 30 days, or who has been transfused within 60 days.
  7. A person who has been administered with the investigational product or a bioequivalence study drug in another clinical trial or a bioequivalence study within 180 days of the screening visit.
  8. A person who has taken a prescription drug, OTC(over the counter drug), herbal medicine, or health-functional food within 14 days of the screening visit.
  9. A person who has smoked excessively within 14 days of the screening visit or whose (> 10 cigarettes/day) urine nicotine test result during the screening period came back positive.
  10. A person who drank excessively within 14 days of screening visit (> 21 units/week).
  11. A person who shows the following results in the vitality sign test during the screening period.

    Systolic blood pressure ≥ 140 (millimeter of mercury) mmHg or <90 mmHg Diastolic blood pressure ≥ 90 mmHg or <60 mmHg Pulse> 100 bpm or < 45 bpm

  12. A person who shows the following in the diagnostic test during the screening period.

    • Aspartate aminotransferase (AST) and aminotransferase (ALT) values exceed the upper limit of reference (UNL) by more than 1.5 times.
    • Bilirubin total value exceeds the upper limit of reference (UNL) by more than 1.5 times.
  13. A person who tested positive in a blood serum test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test) during the screening period.
  14. A person who showed QTc(Heart rate-corrected QT) > 450 ms or clinically significant abnormalities in a 12-electrode electrocardiogram during the screening period.
  15. In addition to Exclusion Criteria 12) to 14), a person who was found to be ineligible to participate in the clinical trials by the diagnostic test or a 12-electrode electrocardiogram.
  16. Any other person who is judged to be inadequate to perform the clinical trials by the investigator.
Layout table for additonal information
Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT03937648    
Other Study ID Numbers: ID-LAS-101
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No