Status:
COMPLETED
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects
Lead Sponsor:
Bukwang Pharmaceutical
Collaborating Sponsors:
Dyna Therapeutics
Conditions:
Prostate Cancer
Eligibility:
MALE
19-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06014853
Start Date
August 10 2023
End Date
November 16 2023
Last Update
February 5 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080