Clinical trial · Interventional
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
NCT06014853CI-TRIAL-00073632completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SOL-804-F | Drug | — | UNRESOLVED |
| Zytiga | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1
- 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
- interventionNames
- Drug: SOL-804-F
- Drug: Zytiga
- type
- EXPERIMENTAL
- label
- Group 2
- 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
- interventionNames
- Drug: SOL-804-F
- Drug: Zytiga
- type
- EXPERIMENTAL
- label
- Group 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. healthy adult male volunteers between 19 to 50 years of age at screening visit. 2. Body mass index (BMI) between 19.0 to 30.0 kg/m2 3. The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent 4. The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.) Exclusion Criteria: 1. Clinically significant abnormal physical examination, vital signs or ECG 2. The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction. 3. The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc. 4. The subjects who have a history of drug abuse or positive with urine drug screening test
References
Publications (0)
Data not yet available
No reference posted for this study.