Clinical Trials/NCT07322991

NCT07322991

Completed

Phase 1

A Phase 1 Clinical Trial With an Open-label, Single-agent Repeated Dosing Followed by Combined Repeated Dosing Design to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects.

Il-Yang Pharm. Co., Ltd.1 site in 1 country43 target enrollmentOctober 14, 2025

InterventionsIY001(Finasteride)IY002(Tamsulosin)

Overview

Phase: Phase 1
Intervention: IY001(Finasteride)
Conditions: Not specified
Sponsor: Il-Yang Pharm. Co., Ltd.
Enrollment: 43
Locations: 1
Primary Endpoint: Finasteride Area Under the Curve during the dosing interval at steady state (AUCτ,ss)
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this stud is to evaluate the drug-drug interaction between IY001 and IY002 in adult males.

Detailed Description

The study is an Open-label, Phase I, drug-drug interaction study.

Registry

clinicaltrials.gov

Start Date

October 14, 2025

End Date

December 1, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Il-Yang Pharm. Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult males aged between 19 and 55 years at screening.
•Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m² (BMI calculated as weight \[kg\] / height \[m\]²).
•No clinically significant congenital or chronic diseases, and no pathological signs or symptoms based on internal medicine examination (including EEG, ECG, chest or upper gastrointestinal endoscopy, or gastrointestinal radiographic examination, if necessary).
•Considered suitable for participation by the principal investigator (or delegated sub-investigator) based on diagnostic tests such as hematology, blood chemistry, serology, urinalysis, ECG, suicide risk assessment, and depression scale evaluation conducted in accordance with the characteristics of the investigational drugs.
•Able to provide written informed consent after receiving a detailed explanation of the clinical trial and voluntarily agreeing to participate and comply with study requirements during the trial period.
•Agree to use highly effective contraception\* (excluding hormonal methods) and refrain from donating sperm from the first dose until at least 4 weeks after the last dose of the investigational drugs. This includes agreement that the subject or their partner will avoid pregnancy.
•\*Highly effective contraception methods include: intrauterine device (IUD), bilateral tubal ligation, vasectomy of partner, or sexual abstinence. Methods such as periodic abstinence (calendar method, basal body temperature, ovulation method), withdrawal, use of spermicides alone, lactational amenorrhea, or simultaneous use of male and female condoms are not considered effective contraception.
•Agree not to donate blood from the first dose until at least 4 weeks after the last dose of the investigational drugs.

Exclusion Criteria

•Use of drug-metabolizing enzyme inducers or inhibitors (e.g., barbiturates) within 30 days prior to the first dose, or use of such medications within 10 days prior to the first dose.
•Participation in a bioequivalence study or other clinical trial involving investigational drugs within 6 months prior to the first dose.
•Whole blood donation within 8 weeks, plasma donation within 2 weeks, or blood transfusion within 4 weeks prior to the first dose.
•History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia surgery).
•Within 1 month prior to the first dose:
•Average alcohol consumption exceeding 21 drinks per week (1 drink = 50 mL soju, 250 mL beer, or 30 mL spirits)
•Smoking more than 20 cigarettes per day
•Any of the following conditions:
•History of hypersensitivity (including angioedema) to the investigational drug or its components
•Orthostatic hypotension

Arms & Interventions

Part A

IY001 -\> IY001 + IY002

Intervention: IY001(Finasteride)

Part A

IY001 -\> IY001 + IY002

Intervention: IY002(Tamsulosin)

Part B

IY002 -\> IY001 + IY002

Intervention: IY001(Finasteride)

Part B

IY002 -\> IY001 + IY002

Intervention: IY002(Tamsulosin)

Outcomes

Primary Outcomes

Finasteride Area Under the Curve during the dosing interval at steady state (AUCτ,ss)

Time Frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 3)

The total drug exposure of finasteride over the dosing interval at steady state.

Finasteride Maximum Plasma Concentration at steady state (Cmax,ss)

Time Frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 3)

The peak plasma concentration of finasteride observed at steady state.

Tamsulosin Area Under the Curve during the dosing interval at steady state (AUCτ,ss)

Time Frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 5)

The total drug exposure of tamsulosin over the dosing interval at steady state.

Tamsulosin Maximum Plasma Concentration at steady state (Cmax,ss)

Time Frame: Measured at steady state after repeated dosing.(Day 8 compared to Day 5)

The peak plasma concentration of tamsulosin observed at steady state.

Secondary Outcomes

Finasteride Time to Maximum Plasma Concentration at steady state (Tmax,ss)(Days 3 and 8)
Finasteride Elimination Half-Life at Steady State (t1/2,ss)(Days 3 and 8)
Finasteride Apparent Clearance at Steady State (CLss/F)(Days 3 and 8)
Finasteride Minimum Plasma Concentration at Steady State (Cmin,ss)(Days 1, 2, 7, and 8)
Finasteride Average Plasma Concentration at Steady State (Cav,ss)(Days 3 and 8)
Finasteride Accumulation Ratio (R)(Days 3 and 8)
Finasteride Peak-Trough Fluctuation (PTF)(Days 3 and 8)
Tamsulosin Time to Maximum Plasma Concentration at Steady State (Tmax,ss)(Days 5 and 8)
Tamsulosin Elimination Half-Life at Steady State (t1/2,ss)(Days 5 and 8)
Tamsulosin Peak-Trough Fluctuation (PTF)(Days 5 and 8)
Tamsulosin Apparent Clearance at Steady State (CLss/F)(Days 5 and 8)
Tamsulosin Minimum Plasma Concentration at Steady State (Cmin,ss)(Days 1, 4, 7, and 8)
Tamsulosin Average Plasma Concentration at Steady State (Cav,ss)(Days 5 and 8)
Tamsulosin Accumulation Ratio (R)(Days 5 and 8)