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

NCT04771390 | Completed Phase 1 FDA Drug

• 1 other identifier: 21416
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (13)

• AUC

  Up to 48 hours after dosing

• AUC(0-24)

  Up to 24 hours after dosing

• Cmax

  Up to 48 hours after dosing

• Number of participants with treatment emergent adverse events and severity of treatment emergent adverse events

  Up to 7 weeks

• Incidence of laboratory abnormalities, based on clinical safety laboratory assessments

  Up to 7 weeks

Study Arms (9)

Part 1: Group A

EXPERIMENTAL

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

Drug: Selitrectinib (BAY2731954) Adult tablet

Part 1: Group B

EXPERIMENTAL

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

Drug: Selitrectinib (BAY2731954) Pediatric tablet

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

Drug: Selitrectinib (BAY2731954) Pediatric tablet; Drug: Selitrectinib (BAY2731954) Oral suspension

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

EXPERIMENTAL

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

Drug: Selitrectinib (BAY2731954) Pediatric tablet; Drug: Selitrectinib (BAY2731954) Oral suspension

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

EXPERIMENTAL

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

Drug: Selitrectinib (BAY2731954) Pediatric tablet; Drug: Selitrectinib (BAY2731954) Oral suspension

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

EXPERIMENTAL

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

Drug: Selitrectinib (BAY2731954) Pediatric tablet; Drug: Selitrectinib (BAY2731954) Oral suspension

Interventions

Selitrectinib (BAY2731954) Adult tablet DRUG

Tablet, oral administration

Part 1: Group A; Part 2 (Group A): Dose A-B-C-D; Part 2 (Group A): Dose B-C-A-D; Part 2 (Group A): Dose C-A-B-D

Selitrectinib (BAY2731954) Pediatric tablet DRUG

Tablet, oral administration

Part 1: Group B; Part 2 (Group B): Dose A-B-C-D; Part 2 (Group B): Dose B-D-A-C; Part 2 (Group B): Dose C-A-D-B; Part 2 (Group B): Dose D-C-B-A

Selitrectinib (BAY2731954) Oral solution DRUG

Oral solution after reconstitution

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

Selitrectinib (BAY2731954) Oral suspension DRUG

Oral suspension after reconstitution

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Parexel International - Los Angeles

Glendale, California, 91206, United States

Location

PAREXEL International, Baltimore

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

selitrectinib; Solutions; Suspensions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Colloids; Complex Mixtures; Dosage Forms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: sequential and non-randomized design Part 2: cross-over and randomized design

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 25, 2021
• Study Start: February 16, 2021
• Primary Completion: May 20, 2021
• Study Completion: July 6, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)