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

• Sponsor: Pharmbio Korea Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04418388
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Actual Duration (Months): 2
• Patients Per Site Per Month: 18.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: PBK-1801; Drug: PBK-1801; Drug: PBK-1801	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 24, 2019
• Actual Primary Completion Date: Dec 3, 2019
• Actual Study Completion Date: Dec 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: PBK-1801; Administered orally
Experimental: B	Drug: PBK-1801; Administered orally
Experimental: C	Drug: PBK-1801; Administered orally

Outcome Measures

Primary Outcome Measures

1. Cmax [5 days]

2. AUClast [5 days]

3. AUCinf [5 days]

4. Tmax [5 days]

5. T1/2 [5 days]

6. CL/F [5 days]

7. Vd/F [5 days]

Secondary Outcome Measures

1. Number of Participants with Adverse Events [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Pharmbio Korea Co., Ltd.

Investigators

• Principal Investigator: SeungHwan Lee, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pharmbio Korea Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04418388
• Other Study ID Numbers: PBK_1801_101
• First Posted: Jun 5, 2020
• Last Update Posted: Jun 5, 2020
• Last Verified: Jun 1, 2020

• 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

Study Results

No Results Posted as of Jun 5, 2020