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

Solid Tumors Harboring NTRK Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771390
• Other study ID #: 21416
• Status: Completed
• Phase: Phase 1
• Start date: February 16, 2021
• Est. completion date: July 6, 2021

Study information

• Verified date: August 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 6, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key 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

Key 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

Related Conditions & MeSH terms

• Solid Tumors Harboring NTRK Fusion

Intervention

Drug:
• Selitrectinib (BAY2731954) Adult tablet
Tablet, oral administration
• Selitrectinib (BAY2731954) Pediatric tablet
Tablet, oral administration
• Selitrectinib (BAY2731954) Oral solution
Oral solution after reconstitution
• Selitrectinib (BAY2731954) Oral suspension
Oral suspension after reconstitution

Locations

Country	Name	City	State
United States	PAREXEL International, Baltimore	Baltimore	Maryland
United States	Parexel International - Los Angeles	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC	Area 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 formulations	Up to 48 hours after dosing
Primary	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 formulations	Up to 24 hours after dosing
Primary	Cmax	Maximum 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 formulations	Up to 48 hours after dosing
Secondary	AUC	Area 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 solution	Up to 48 hours after dosing
Secondary	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 solution	Up to 24 hours after dosing
Secondary	Cmax	Maximum observed drug concentration in measured matrix after single dose administration; To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solution	Up to 48 hours after dosing
Secondary	Number of participants with treatment emergent adverse events and severity of treatment emergent adverse events	Adverse events that occur or worsen after the first dose of study medication	Up to 7 weeks
Secondary	Incidence of laboratory abnormalities, based on clinical safety laboratory assessments	Hematology, clinical chemistry and urinalysis test results	Up to 7 weeks
Secondary	Ventricular rate		Up to 7 weeks
Secondary	ECG PR interval		Up to 7 weeks
Secondary	ECG QT interval		Up to 7 weeks
Secondary	ECG QRS duration		Up to 7 weeks
Secondary	Blood pressure in mmHg		Up to 7 weeks
Secondary	Heart rate in bpm	bpm: beats per minute	Up to 7 weeks
Secondary	Body temperature in Celsius		Up to 7 weeks
Secondary	Respiratory rate in breaths/min		Up to 7 weeks