NCT05677035

Brief Summary

A single-center, open-label, parallel-group, phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of LINO-1713 in healthy Korean female subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

January 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

December 21, 2022

Last Update Submit

January 9, 2023

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics parameters: Cmax

    Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours

  • Pharmacokinetics parameters: Tmax

    Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours

Study Arms (2)

Pharmacokinetic evaluation

EXPERIMENTAL

LINO-1713 (Estetrol 15mg/Drospirenone 3mg)

Drug: LINO-1713 1 tablet

Pharmacodynamic evaluation

EXPERIMENTAL

LINO-1713 (Estetrol 15mg/Drospirenone 3mg)

Drug: LINO-1713 once a day for 24 days

Interventions

LINO-1713 1 tabletDRUG

LINO-1713 1 tablet is administered once. Oral administration with 200mL of water

Pharmacokinetic evaluation
LINO-1713 once a day for 24 daysDRUG

Oral administration is performed with 200 mL of water. Instruct subjects to take the drug at the same time as possible.

Pharmacodynamic evaluation

Eligibility Criteria

Age19 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with a Body Mass Index (BMI) between 18kg/m2 \~ 28kg/m2

You may not qualify if:

  • Clinically significant cardiovascular disease, respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 10, 2023

Study Start

January 11, 2022

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

KR(1)