Trial Condition(s):
Solid tumors harboring NTRK fusion
Study to compare how the body absorbs, distributes and excretes the drug selitrectinib (BAY2731954) given as two different tablet formulations or as liquid formulations including the effect of food on the absorption, distribution or excretion of the different formulations in healthy participants
Bayer Identifier:
21416
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
In this study, the researchers will compare 2 new tablet forms of BAY2731954 with liquid oral forms of BAY2731954. A maximum of 61 healthy volunteers aged 18 to 55 will be asked to participate.
The study will have 2 parts. In part 1 researchers want to gather information how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations. Participants will take the study drugs on 3 days separated by breaks of at least 3 days between each intake. The duration of this study part will be in total of up to 6 weeks from first screening visit to follow-up visit.
In part 2 of the study researchers want to study how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations with or without food or as 2 liquid oral formulations. Participants will take the study drugs on 4 days separated by breaks of at least 3 days between each intake. The duration of the second part of study part will be in total of up to 7 weeks from first screening visit to follow-up visit.
During the study, researchers will collect blood and urine samples. In addition, doctors will check the participants’ overall health. They will also ask the participants if they have any medical problems.
Inclusion Criteria
- Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac and neurologic examination - Body mass index (BMI): ≥18.5 and ≤ 29.9 kg/m2, with body weight ≥50 kg - Use of adequate contraception until 3 months after last study intervention
Exclusion Criteria
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (e.g. seizures) or other organs (e.g. diabetes mellitus). - Medical history of risk factors for Torsades de pointes (e.g. family history of Long QT Syndrome) or other arrhythmias - Known severe allergies, allergies requiring therapy with corticosteroids, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated asymptomatic seasonal allergies such as non-severe hay fever during the time of study conduct). - Regular use of medicines - Regular alcohol consumption - Smoking more than 5 cigarettes daily - History of COVID-19 or current SARS-CoV-2 infection
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Parexel International - Los Angeles Glendale, United States, 91206 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PAREXEL International, Baltimore Baltimore, United States, 21225 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
An open-label, Phase I study to evaluate the relative bioavailability, food effect and pharmacokinetic linearity of 2 new tablet formulations (adult and pediatric) of selitrectinib (BAY 2731954) in relative to oral suspension and the Liquid Service Formulation in healthy adult participants
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
9
Primary Outcome
- AUCArea under the plasma concentration vs. time curve from 0 to infinity after single dose To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulationsTimeframe: Up to 48 hours after dosing
- AUC(0-24)Area under the plasma concentration vs. time curve from 0 to 24 hours after single dose To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulationsTimeframe: Up to 24 hours after dosing
- CmaxMaximum observed drug concentration in measured matrix after single dose administration To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulationsTimeframe: Up to 48 hours after dosing
Secondary Outcome
- AUCArea under the plasma concentration vs. time curve from 0 to infinity after single dose. To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solutionTimeframe: Up to 48 hours after dosing
- AUC(0-24)Area under the plasma concentration vs. time curve from 0 to 24 hours after single dose To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solutionTimeframe: Up to 24 hours after dosing
- CmaxMaximum observed drug concentration in measured matrix after single dose administration To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solutionTimeframe: Up to 48 hours after dosing
- Number of participants with treatment emergent adverse events and severity of treatment emergent adverse eventsAdverse events that occur or worsen after the first dose of study medicationTimeframe: Up to 7 weeks
- Incidence of laboratory abnormalities, based on clinical safety laboratory assessmentsHematology, clinical chemistry and urinalysis test resultsTimeframe: Up to 7 weeks
- Ventricular rateTimeframe: Up to 7 weeks
- ECG PR intervalTimeframe: Up to 7 weeks
- ECG QT intervalTimeframe: Up to 7 weeks
- ECG QRS durationTimeframe: Up to 7 weeks
- Blood pressure in mmHgTimeframe: Up to 7 weeks
- Heart rate in bpmbpm: beats per minuteTimeframe: Up to 7 weeks
- Body temperature in CelsiusTimeframe: Up to 7 weeks
- Respiratory rate in breaths/minTimeframe: Up to 7 weeks
Additional Information
Not Available
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