CompletedNCT05089279Updated Oct 7, 2022

Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

A Phase 1 interventional study of D113 and CKD-349 in Chronic Heart Failure, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 71
Allocation: Randomized
Ages: 19 Years and older
Sex: All

Study summary

Study to Evaluate the Safety and Pharmacokinetics of CKD-349

Read the detailed description

An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

Conditions studied

Chronic Heart Failure

In context

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 299 studies on the registry; 15 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy adult volunteers aged ≥ 19 years
Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
Those who agree to contraception until 7 days after clinical trial.
Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion criteria

Exclusion Criteria:

Those who have clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products or take drugs that may interfere with this clinical trials within 10 day before the first administration
Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
Those who donated whole blood within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB).
Those who are deemed insufficient to participate in this clinical study by investigators.
Woman who are pregnant or breastfeeding.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 71 participants (actual)

Study arms

Experimental
Sequence 1
Period 1: D113/ Period 2: CKD-349
Drug: D113 · Drug: CKD-349
Experimental
Sequence2
Period 1: CKD-349/ Period 2: D113
Drug: D113 · Drug: CKD-349

Interventions

DrugD113
QD, PO
DrugCKD-349
QD, PO

What researchers measure

Primary outcomes

AUCt of CKD-349
AUCt: Area under the concentration-time curve from time zero to time
Time frame: 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Cmax of CKD-349
Cmax: Maximum plasma concentration of the drug
Time frame: 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

Secondary outcomes

AUCinf of CKD-349
Area under the concentration-time curve from zero up to ∞
Time frame: 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Tmax of CKD-349
Time to maximum plasma concentration
Time frame: 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
AUCt/AUCinf of CKD-349
AUCt/AUCinf
Time frame: 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
T1/2 of CKD-349
Terminal elimination half-life
Time frame: 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

Study locations

1 site

H Plus Yangji Hospital
Seoul, Gwanak-gu 08779, South Korea

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2021 to primary completion in Jan 2022, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 14, 2021
First posted: Oct 22, 2021
StartActual: Nov 3, 2021
Primary completionActual: Jan 18, 2022
CompletionActual: Apr 6, 2022
Last update: Oct 7, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05089279
Lead sponsor: Chong Kun Dang Pharmaceutical
Responsible party: Sponsor
First posted: Oct 22, 2021
Start date: Nov 3, 2021
Primary completion: Jan 18, 2022
Completion: Apr 6, 2022
Last update: Oct 7, 2022

Study contacts

JaeWoo Kim

principal investigator · Study Principal Investigator

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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