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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03937648

Recruitment Status Not yet recruiting

First Posted May 6, 2019

Last update posted May 6, 2019

Study Description

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:Healthy
  • Intervention/Treatment: Drug: COL-144 50mg
    Drug: COL-144 100mg
    Drug: COL-144 200mg
    Drug: COL-144 400mg
    Drug: Placebo
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: October 2019
  • Estimated Study Completion Date: December 2019
Arms and interventions
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
Outcome Measures
  • 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) ]
Eligibility Criteria
  • Ages Eligible for Study: 19 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 100 bpm or 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.

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

IlDong Pharmaceutical Co Ltd

More Information
  • Responsible Party: IlDong Pharmaceutical Co Ltd
  • ClinicalTrials.gov Identifier: NCT03937648 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No