Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women

A Single Center, Open-label Clinical Trial to Evaluate Pharmacokinetic Characteristics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: PBK-1801

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: B	Drug: PBK-1801; Administered orally
EXPERIMENTAL: A	Drug: PBK-1801; Administered orally
EXPERIMENTAL: C	Drug: PBK-1801; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events	30 days

Collaborators and Investigators

• Sponsor: Pharmbio Korea Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 24, 2019
• Primary Completion (ACTUAL): December 3, 2019
• Study Completion (ACTUAL): December 23, 2019

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (ACTUAL): June 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PBK_1801_101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes