NCT06014853CompletedPhase 1
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects
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
Source: ClinicalTrials.gov · Last updated 5 Feb 2024
Brief summary (registry, in English)
Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 14 Aug 2023
- Start date
- 10 Aug 2023
- Primary completion date
- 28 Oct 2023
- Lead sponsor
- Bukwang Pharmaceutical
- Diseases
- Prostate cancer
- NCT number
- NCT06014853
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 48
- From 10 Aug 2023 to the primary completion date, 28 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 history of drug abuse or positive with urine drug screening test
Lab values
- The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
Other
- Clinically significant abnormal physical examination, vital signs or ECG
Who the study is looking for
- 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.)
Age in the registry: 19 years to 50 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.