Clinical trial · Interventional
A Study of [14C]GB491 in Male Healthy Subjects
A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects
- 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 is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered. In addition, this study will also evaluate the safety of a single dose of \[14C\]GB491 when given to healthy subjects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [14C]GB491 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [14C]GB491
- interventionNames
- Drug: [14C]GB491
Primary outcomes (3)
- measure
- Total radioactivity in plasma PK
- timeFrame
- Up to 168 hours post dose
- description
- To investigate the distribution ratio of total radioactivity in whole blood to plasma and pharmacokinetic characteristics of total radioactivity in plasma in healthy subjects after a single dose of \[14C\]GB491.
- measure
- Total radioactivity in urine and fecal samples
- timeFrame
- Up to 360 hours post dose
- description
- Quantitative analysis of total radioactivity in urine or feces in healthy subjects after a single dose of \[14C\]GB491.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * A healthy male volunteer between 18 and 50 years of age inclusive * A total body weight \>=50kg, and a BMI of 19.0-26.0 kg/m2 * A signed informed consent document Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * Subjects with HBsAg-positive, or HCV-Ab-positive, or TPPA-positive, or HIV infection * Subjects with a history of habitual constipation/diarrhea, irritable bowel syndrome, or inflammatory bowel disease
References
Publications (0)
Data not yet available