A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers

NCT06518122 | Completed Phase 1

• 1 other identifier: HM-ROEM-101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCtau

  Pharmacokinetic evaluation

  [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

• Css,max

  Pharmacokinetic evaluation

  [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

Secondary Outcomes (8)

• Css,min

  [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

• Css,av

  [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

• Tss,max

  [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

• t1/2

  [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

• CLss/F

  [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

Study Arms (7)

[PART A] Sequence 1

EXPERIMENTAL

Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302)

Drug: HCP1306; Drug: RLD2302

[PART A] Sequence 2

EXPERIMENTAL

Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302)

Drug: HCP1306; Drug: RLD2302

[PART A] Sequence 3

EXPERIMENTAL

Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306)

Drug: HCP1306; Drug: RLD2302

[PART A] Sequence 4

EXPERIMENTAL

Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306)

Drug: HCP1306; Drug: RLD2302

[PART A] Sequence 5

EXPERIMENTAL

Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302)

Drug: HCP1306; Drug: RLD2302

[PART A] Sequence 6

EXPERIMENTAL

Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302)

Drug: HCP1306; Drug: RLD2302

[PART B] Single arm

EXPERIMENTAL

Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)

Drug: HCP1306; Drug: RLD2302; Drug: RLD2102

Interventions

HCP1306 DRUG

Take it once a day per period.

[PART A] Sequence 1; [PART A] Sequence 2; [PART A] Sequence 3; [PART A] Sequence 4; [PART A] Sequence 5; [PART A] Sequence 6; [PART B] Single arm

RLD2302 DRUG

Take it once a day per period.

[PART A] Sequence 1; [PART A] Sequence 2; [PART A] Sequence 3; [PART A] Sequence 4; [PART A] Sequence 5; [PART A] Sequence 6; [PART B] Single arm

RLD2102 DRUG

Take it once a day per period

[PART B] Single arm

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 19\~54 years in healthy volunteers
• kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
• mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
• Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
• Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

Study Officials

• Min-gul Kim, MD

  Jeonbuk National University Hospital

  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

Model Details: \[PART A\] 6 x 3 Crossover \[PART B\] Single Arm (Three periods)

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: September 1, 2024
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)