Clinical trial · Interventional
A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects
NCT06619951CI-TRIAL-00083520completedPhase 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)
This study will adopt a Single-center, Single-arm, Open, Fixed Sequence design to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects.
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 |
|---|---|---|---|
| Locally Advanced or Metastatic Solid Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VC004 and Itraconazole | Drug | — | UNRESOLVED |
| VC004 and rifampicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1: VC004 and itraconazole
- interventionNames
- Drug: VC004 and Itraconazole
- type
- EXPERIMENTAL
- label
- Group 2: VC004 and rifampicin
- interventionNames
- Drug: VC004 and rifampicin
Primary outcomes (2)
- measure
- Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- Day1-Day16
- description
- Maximum Observed Plasma Concentration (Cmax)
- measure
- Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions; * Able to complete the study in compliance with the protocol; * Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 6 months after the last dose of study drug; * Male and female subjects between the ages of 18 and 45 years, inclusive; * At least 50.0kg for male subjects, 45.0kg for female subjects, with a Body Mass Index between 19.0-26.0 kg/m2, inclusive; Exclusion Criteria: * More than 5 cigarettes per day on average within 3 months prior to screening; * with A history of allergies, including medications, foods, mites, etc., or those known to be potentially allergic to drugs similar to the study drug, or those known to be allergic to itraconazole, rifampicin, or any excipients; * History of drug and/or alcohol abuse (alcoholism defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or or have used drugs within the past five years; * Donation or loss of a significant volume of blood (\>400 mL) within 3 months prior to screening;
References
Publications (0)
Data not yet available
No reference posted for this study.