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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418388
• Other study ID #: PBK_1801_101
• Status: Completed
• Phase: Phase 1
• Start date: October 24, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: June 2020
• Source: Pharmbio Korea Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 23, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• PBK-1801
Administered orally
• PBK-1801
Administered orally
• PBK-1801
Administered orally

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		5 days
Primary	AUClast		5 days
Primary	AUCinf		5 days
Primary	Tmax		5 days
Primary	T1/2		5 days
Primary	CL/F		5 days
Primary	Vd/F		5 days
Secondary	Number of Participants with Adverse Events		30 days