NCT07532148

Brief Summary

Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
12mo left

Started Jun 2026

Shorter than P25 for phase_1 ovarian-cancer

Status
not yet recruiting

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 Progress14%
Jun 2026Aug 2027

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

  • AUCtau

    Area under the plasma concentration-time curve over the dosing interval at steady state

    0~12 hours

  • Css,max

    Maximum observed plasma concentration at steady state

    0~12 hours

Study Arms (2)

Experimental group 1

EXPERIMENTAL

Period 1: Test drug(CKD-215) Period 2: Reference drug(D215)

Drug: CKD-215Drug: D215

Experimental group 2

EXPERIMENTAL

Period 1: Reference drug(D215) Period 2: Test drug(CKD-215)

Drug: CKD-215Drug: D215

Interventions

CKD-215DRUG

2 tablets BID at 12-hour intervals for 7 days

Also known as: TEST drug
Experimental group 1Experimental group 2
D215DRUG

2 tablets BID at 12-hour intervals for 7 days

Also known as: Reference drug
Experimental group 1Experimental group 2

Eligibility Criteria

Age19 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is limited to female participants because the target diseases (ovarian cancer, fallopian tube cancer, and primary peritoneal cancer) occur in women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 19 aged and 75 aged in patients with advanced BRCA-mutated high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
  • kg/m2≤body mass index(BMI)≤28.0kg/m2

You may not qualify if:

  • Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
  • Patients with central nervous system metastases, unless clinically stable after treatment
  • CTCAE Grade 3 or higher adverse events(e.g., anemia, neutropenia, dysgeusia, cough, leukopenia, thrombocytopenia) related to D215
  • Subjects who are unable to participate in this clinical trial at the discretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Jeong-Yeol Park, Ph.D

    Asan Medical Center

    STUDY CHAIR

Central Study Contacts

Jeong-Yeol Park, Ph.D

CONTACT

82-2-3010-3646catgut1-0@hanmail.net

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

April 9, 2026

First Posted

April 15, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04