Back to resultsA Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SOL-804-F
Zytiga
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Abiraterone
Eligibility Criteria
Inclusion Criteria: healthy adult male volunteers between 19 to 50 years of age at screening visit. Body mass index (BMI) between 19.0 to 30.0 kg/m2 The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.) Exclusion Criteria: Clinically significant abnormal physical examination, vital signs or ECG The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction. The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc. The subjects who have a history of drug abuse or positive with urine drug screening test
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Period 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg
Period 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg
Period 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg
Period 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg
Outcomes
Primary Outcome Measures
AUClast of abiraterone
Area under the plasma drug concentration-time curve from 0 to last
Cmax of abiraterone
The maximum or peak concentration between zero and dosing interval
Secondary Outcome Measures
AUCinf of abiraterone
Area under the plasma drug concentration-time curve from 0 to infinity
Tmax of abiraterone
Time of Maximum Concentration
t1/2 of abiraterone
Terminal Half-life
CL/F of abiraterone
An estimate of the total body clearance after oral administration
Vd/F of abiraterone
Apparent volume of distribution after extravascular administration
Full Information
NCT ID
NCT06014853
First Posted
August 14, 2023
Last Updated
August 25, 2023
Sponsor
Bukwang Pharmaceutical
Collaborators
Dyna Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT06014853
Brief Title
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects
Official Title
A Randomized, Open-label, Four-sequence, Four-period, Crossover, Single Dosing, Phase 1 Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetics of SOL-804 and Zytiga in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bukwang Pharmaceutical
Collaborators
Dyna Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study
Detailed Description
To evaluate the safety, tolerability and pharmacokinetic characteristics of SOL-804-F and Zytiga tablets following a single oral dose and Zytiga 1,000 mg in healthy male volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Abiraterone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Period 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Period 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Period 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Period 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg
Intervention Type
Drug
Intervention Name(s)
SOL-804-F
Other Intervention Name(s)
SOL-804-F 181.5mg/242.0mg/302.5mg
Intervention Description
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.
Intervention Type
Drug
Intervention Name(s)
Zytiga
Other Intervention Name(s)
Zytiga 500mg
Intervention Description
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.
Primary Outcome Measure Information:
Title
AUClast of abiraterone
Description
Area under the plasma drug concentration-time curve from 0 to last
Time Frame
72 hours
Title
Cmax of abiraterone
Description
The maximum or peak concentration between zero and dosing interval
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
AUCinf of abiraterone
Description
Area under the plasma drug concentration-time curve from 0 to infinity
Time Frame
72 hours
Title
Tmax of abiraterone
Description
Time of Maximum Concentration
Time Frame
72 hours
Title
t1/2 of abiraterone
Description
Terminal Half-life
Time Frame
72 hours
Title
CL/F of abiraterone
Description
An estimate of the total body clearance after oral administration
Time Frame
72 hours
Title
Vd/F of abiraterone
Description
Apparent volume of distribution after extravascular administration
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Rmax of serum testosterone
Description
The maximum response
Time Frame
72 hours
Title
Imax of serum testosterone
Description
Maximum inhibition
Time Frame
72 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy adult male volunteers between 19 to 50 years of age at screening visit.
Body mass index (BMI) between 19.0 to 30.0 kg/m2
The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent
The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.)
Exclusion Criteria:
Clinically significant abnormal physical examination, vital signs or ECG
The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction.
The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
The subjects who have a history of drug abuse or positive with urine drug screening test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mira Son
Phone
82-2-828-8077
Email
mi.ra.son@bukwang.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SeungHwan Lee
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SeungHwan Lee
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects
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