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

NCT05089279 | Completed Phase 1

• 1 other identifier: A111_01BE2019
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Evaluate the Safety and Pharmacokinetics of CKD-349

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-349

  AUCt: Area under the concentration-time curve from time zero to time

  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

  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 (4)

• AUCinf of CKD-349

  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

  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

  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

  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 Arms (2)

Sequence 1

EXPERIMENTAL

Period 1: D113/ Period 2: CKD-349

Drug: D113; Drug: CKD-349

Sequence2

EXPERIMENTAL

Period 1: CKD-349/ Period 2: D113

Drug: D113; Drug: CKD-349

Interventions

D113 DRUG

QD, PO

Sequence 1; Sequence2

CKD-349 DRUG

QD, PO

Sequence 1; Sequence2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location

Study Officials

• JaeWoo Kim

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 22, 2021
• Study Start: November 3, 2021
• Primary Completion: January 18, 2022
• Study Completion: April 6, 2022
• Last Updated: October 7, 2022

Record last verified: 2021-12

Locations

KR (1)