NCT04418388

Brief Summary

The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2019

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

October 24, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

May 26, 2020

Last Update Submit

June 2, 2020

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (7)

  • Cmax

    5 days

  • AUClast

    5 days

  • AUCinf

    5 days

  • Tmax

    5 days

  • T1/2

    5 days

  • CL/F

    5 days

  • Vd/F

    5 days

Secondary Outcomes (1)

  • Number of Participants with Adverse Events

    30 days

Study Arms (3)

A

EXPERIMENTAL
Drug: PBK-1801

B

EXPERIMENTAL
Drug: PBK-1801

C

EXPERIMENTAL
Drug: PBK-1801

Interventions

PBK-1801DRUG

Administered orally

A

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI) between 19 and 30 kg/m²
  • Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator)
  • Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions

You may not qualify if:

  • History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease
  • Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease).
  • History or current alcohol abuse or drug addiction
  • Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

  • SeungHwan Lee

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 5, 2020

Study Start

October 24, 2019

Primary Completion

December 3, 2019

Study Completion

December 23, 2019

Last Updated

June 5, 2020

Record last verified: 2020-06

Locations

KR(1)