NCT05407220

Brief Summary

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

June 29, 2022

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

26 days

First QC Date

May 27, 2022

Last Update Submit

October 7, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (21)

  • Cmax of Losartan

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • AUC last of Losartan

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • AUC inf of Losartan

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • Tmax of Losartan

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • t1/2 of Losartan

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • CL/F of Losartan

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • Vd/F of Losartan

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • Cmax of EXP3174

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • AUC last of EXP3174

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • AUC inf of EXP3174

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • Tmax of EXP3174

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • t1/2 of EXP3174

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • CL/F of EXP3174

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • Vd/F of EXP3174

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • Cmax of Chlorthalidone

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • AUC last of Chlorthalidone

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • AUC inf of Chlorthalidone

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • Tmax of Chlorthalidone

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • t1/2 of Chlorthalidone

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • CL/F of Chlorthalidone

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

  • Vd/F of Chlorthalidone

    pharmacokinetic evaluation

    Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours

Study Arms (2)

group1

EXPERIMENTAL

Period1: HCP1904-1

Drug: HCP1904-1

group2

EXPERIMENTAL

Period1: HCP1904-3

Drug: HCP1904-3

Interventions

HCP1904-1DRUG

take it once per period

group1
HCP1904-3DRUG

take it once per period

group2

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 19\~45 years in healthy male volunteers
  • Weight ≥ 55kg and BMI 18 \~ 30 kg/m\^2
  • Subjects who agree to use medically accepted dual contraceptives up to 14 days after the last administration date of the clinical trial drug and not to provide sperm.
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

You may not qualify if:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  • Subjects who judged ineligible by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yangji Hospital

Seoul, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 7, 2022

Study Start

June 29, 2022

Primary Completion

July 25, 2022

Study Completion

July 25, 2022

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)