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

NCT ID: NCT04771390

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2021-07-06

Brief 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.

Conditions

Solid Tumors Harboring NTRK Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 1: Group A

Participants will receive 3 single doses of selitrectinib in adult tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days

Group Type: EXPERIMENTAL

Selitrectinib (BAY2731954) Adult tablet

Intervention Type: DRUG

Tablet, oral administration

Part 1: Group B

Participants will receive 3 single doses of selitrectinib in pediatric tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days

Group Type: EXPERIMENTAL

Selitrectinib (BAY2731954) Pediatric tablet

Intervention Type: DRUG

Tablet, oral administration

Part 2 (Group A): Dose A-B-C-D

Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days

Group Type: EXPERIMENTAL

Selitrectinib (BAY2731954) Adult tablet

Intervention Type: DRUG

Tablet, oral administration

Selitrectinib (BAY2731954) Oral solution

Intervention Type: DRUG

Oral solution after reconstitution

Selitrectinib (BAY2731954) Oral suspension

Intervention Type: DRUG

Oral suspension after reconstitution

Part 2 (Group A): Dose B-C-A-D

Participants will receive dose B, C, A and D sequentially. The washing-out period between each dose is at least 3 days

Group Type: EXPERIMENTAL

Selitrectinib (BAY2731954) Adult tablet

Intervention Type: DRUG

Tablet, oral administration

Selitrectinib (BAY2731954) Oral solution

Intervention Type: DRUG

Oral solution after reconstitution

Selitrectinib (BAY2731954) Oral suspension

Intervention Type: DRUG

Oral suspension after reconstitution

Part 2 (Group A): Dose C-A-B-D

Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days

Group Type: EXPERIMENTAL

Selitrectinib (BAY2731954) Adult tablet

Intervention Type: DRUG

Tablet, oral administration

Selitrectinib (BAY2731954) Oral solution

Intervention Type: DRUG

Oral solution after reconstitution

Selitrectinib (BAY2731954) Oral suspension

Intervention Type: DRUG

Oral suspension after reconstitution

Part 2 (Group B): Dose A-B-C-D

Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days

Group Type: EXPERIMENTAL

Selitrectinib (BAY2731954) Pediatric tablet

Intervention Type: DRUG

Tablet, oral administration

Selitrectinib (BAY2731954) Oral suspension

Intervention Type: DRUG

Oral suspension after reconstitution

Part 2 (Group B): Dose B-D-A-C

Participants will receive dose B, D, A and C sequentially. The washing-out period between each dose is at least 3 days

Group Type: EXPERIMENTAL

Selitrectinib (BAY2731954) Pediatric tablet

Intervention Type: DRUG

Tablet, oral administration

Selitrectinib (BAY2731954) Oral suspension

Intervention Type: DRUG

Oral suspension after reconstitution

Part 2 (Group B): Dose C-A-D-B

Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days

Group Type: EXPERIMENTAL

Selitrectinib (BAY2731954) Pediatric tablet

Intervention Type: DRUG

Tablet, oral administration

Selitrectinib (BAY2731954) Oral suspension

Intervention Type: DRUG

Oral suspension after reconstitution

Part 2 (Group B): Dose D-C-B-A

Participants will receive dose D, C, B and A sequentially. The washing-out period between each dose is at least 3 days

Group Type: EXPERIMENTAL

Selitrectinib (BAY2731954) Pediatric tablet

Intervention Type: DRUG

Tablet, oral administration

Selitrectinib (BAY2731954) Oral suspension

Intervention Type: DRUG

Oral suspension after reconstitution

Interventions

Selitrectinib (BAY2731954) Adult tablet

Tablet, oral administration

Intervention Type: DRUG

Selitrectinib (BAY2731954) Pediatric tablet

Tablet, oral administration

Intervention Type: DRUG

Selitrectinib (BAY2731954) Oral solution

Oral solution after reconstitution

Intervention Type: DRUG

Selitrectinib (BAY2731954) Oral suspension

Oral suspension after reconstitution

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Parexel International - Los Angeles

Glendale, California, United States

PAREXEL International, Baltimore

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

21416

Identifier Type: -

Identifier Source: org_study_id