CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167, Germany
NCT Number: NCT04275960
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.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Mannheim, Baden-Wurttemberg, 68167, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Tyrosine receptor kinase (TRK) inhibitor
Time frame: Up to 3 days
Time frame: Up to 1 day
Time frame: Up to 3 days
Time frame: Up to 3 days
Time frame: Up to 1 days
Time frame: Up to 3 days
Time frame: Up to 23 weeks
Bayer
Industry
An Open-label, Non-randomized, Phase I Study to Evaluate the Pharmacokinetics of Selitrectinib (BAY 2731954) and Food Effects in Healthy Adult Male Participants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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