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

Status and phase: Completed; Phase 1

Conditions: Solid Tumors Harboring NTRK Fusion

Treatments: Drug: Selitrectinib (BAY2731954) Adult tablet; Drug: Selitrectinib (BAY2731954) Oral suspension; Drug: Selitrectinib (BAY2731954) Oral solution; Drug: Selitrectinib (BAY2731954) Pediatric tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04771390

21416

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 9 patient groups

Part 1: Group A

Experimental group

Description:

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

Treatment:

Drug: Selitrectinib (BAY2731954) Adult tablet

Part 1: Group B

Experimental group

Description:

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

Treatment:

Drug: Selitrectinib (BAY2731954) Pediatric tablet

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

Experimental group

Description:

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

Treatment:

Drug: Selitrectinib (BAY2731954) Oral suspension

Drug: Selitrectinib (BAY2731954) Oral solution

Drug: Selitrectinib (BAY2731954) Adult tablet

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

Experimental group

Description:

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

Treatment:

Drug: Selitrectinib (BAY2731954) Oral suspension

Drug: Selitrectinib (BAY2731954) Oral solution

Drug: Selitrectinib (BAY2731954) Adult tablet

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

Experimental group

Description:

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

Treatment:

Drug: Selitrectinib (BAY2731954) Oral suspension

Drug: Selitrectinib (BAY2731954) Oral solution

Drug: Selitrectinib (BAY2731954) Adult tablet

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

Experimental group

Description:

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

Treatment:

Drug: Selitrectinib (BAY2731954) Pediatric tablet

Drug: Selitrectinib (BAY2731954) Oral suspension

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

Experimental group

Description:

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

Treatment:

Drug: Selitrectinib (BAY2731954) Pediatric tablet

Drug: Selitrectinib (BAY2731954) Oral suspension

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

Experimental group

Description:

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

Treatment:

Drug: Selitrectinib (BAY2731954) Pediatric tablet

Drug: Selitrectinib (BAY2731954) Oral suspension

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

Experimental group

Description:

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

Treatment:

Drug: Selitrectinib (BAY2731954) Pediatric tablet

Drug: Selitrectinib (BAY2731954) Oral suspension