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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003870-23 | EudraCT Number |
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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.
The primary objectives of this study are to investigate the pharmacokinetics and the effect of food on the pharmacokinetics of selitrectinib after a single dose of the drug.
Secondary objective is to assess the safety of selitrectinib after a single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm_25 + 75 mg (Fasted) | Experimental | Healthy male participants receive a single dose of 25 mg selitrectinib (Period 1) and 75 mg selitrectinib (Period 2) in fasted state. |
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| Arm_50 + 50 mg (Fasted/Fed) | Experimental | Healthy male participants receive a single dose of 50 mg selitrectinib in fasted state (Period 1) and 50 mg selitrectinib in fed state (Period 2). |
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| Arm_100 + 150 mg (Fasted) | Experimental | Healthy male participants receive a single dose of 100 mg selitrectinib (Period 1) and 150 mg selitrectinib (Period 2) in fasted state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selitrectinib (BAY2731954) | Drug | Selitrectinib is administered orally as liquid suspension (20 mg/mL) on Day 1 of each period. Each period lasts 4 days, both periods of each arm are separated by at least 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of selitrectinib in plasma in fasted state (Cmax_fasted) | Up to 3 days | |
| Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted) | Up to 1 day | |
| Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fasted state (AUC_fasted) | Up to 3 days | |
| Maximum concentration of selitrectinib in plasma in fed state (Cmax_fed) | Up to 3 days | |
| Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fed state (AUC(0-24)_fed) | Up to 1 days | |
| Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fed state (AUC_fed) | Up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | Up to 23 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical-Research-Services Mannheim GmbH | Mannheim | Baden-Wurttemberg | 68167 | Germany |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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|
| ID | Term |
|---|---|
| C000629855 | selitrectinib |
| D020794 | Receptor Protein-Tyrosine Kinases |
| ID | Term |
|---|---|
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
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