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Selitrectinib (BAY2731954)Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (1)
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drug3285 | human cord tissue mesenchymal stromal cells Wiki | 1.00 |
Correlated MeSH Terms (2)
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D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
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There is one clinical trial.
Clinical Trials
The researchers in this study want to gather information in healthy adult male participants
about how the human body absorbs, distributes and excretes the drug selitrectinib including
the effect of the interaction of food with the study drug on the human body. Selitrectinib is
a new drug under development for the treatment of patients with solid tumor caused by a
genetic abnormality known as an NTRK gene fusion which cannot be cured by currently available
treatment options or has spread to other parts of the body. The drug blocks the action of the
NTRK gene fusion and prevents the activation of certain proteins (TRK fusion proteins), which
can cause cancer cells to multiply and form a tumor. Researchers also want to find out if the
participants have any medical problems during this study.
Participants in this study will receive the study drug twice with at least 6 days in between.
The study drug will be taken orally as a liquid before or after meal. Observation will last
for up to 8 weeks, and blood samples will be taken from the participants to measure the blood
levels of the study drug.
NCT04275960 Solid Tumors Harboring NTRK Fusion Drug: Selitrectinib (BAY2731954)
Primary Outcomes
Measure: Maximum concentration of selitrectinib in plasma in fasted state (Cmax_fasted) Time: Up to 3 days
Measure: Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted) Time: Up to 1 day
Measure: Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fasted state (AUC_fasted) Time: Up to 3 days
Measure: Maximum concentration of selitrectinib in plasma in fed state (Cmax_fed) Time: Up to 3 days
Measure: Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fed state (AUC(0-24)_fed) Time: Up to 1 days
Measure: Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fed state (AUC_fed) Time: Up to 3 days
Secondary Outcomes
Measure: Number of participants with treatment-emergent adverse events (TEAEs) Time: Up to 23 weeks
No related HPO nodes (Using clinical trials)