Study in Healthy Adult Male Participants to Gather Information How the Human Body Absorbs, Distributes and Excretes the Study Drug Selitrectinib Including the Effect of the Interaction of Food With the Study Drug on the Human Body

NCT04275960 | Completed Phase 1

• 2 other identifiers: 211222019-003870-23
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers in this study want to gather information in healthy adult male participants about how the human body absorbs, distributes and excretes the drug selitrectinib including the effect of the interaction of food with the study drug on the human body. Selitrectinib is a new drug under development for the treatment of patients with solid tumor caused by a genetic abnormality known as an NTRK gene fusion which cannot be cured by currently available treatment options or has spread to other parts of the body. The drug blocks the action of the NTRK gene fusion and prevents the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. Researchers also want to find out if the participants have any medical problems during this study. Participants in this study will receive the study drug twice with at least 6 days in between. The study drug will be taken orally as a liquid before or after meal. Observation will last for up to 8 weeks, and blood samples will be taken from the participants to measure the blood levels of the study drug.

Conditions

Solid Tumors Harboring NTRK Fusion

Keywords

Healthy volunteers; Pharmacokinetics; Food-Drug Interactions; Advanced or metastatic solid tumors; Neurotrophic tyrosine receptor kinase (NTRK) gene fusion; Tyrosine receptor kinase (TRK); TRK inhibitor; Drug formulation; Liquid suspension

Outcome Measures

Primary Outcomes (6)

• Maximum concentration of selitrectinib in plasma in fasted state (Cmax_fasted)

  Up to 3 days

• Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted)

  Up to 1 day

• Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fasted state (AUC_fasted)

  Up to 3 days

• Maximum concentration of selitrectinib in plasma in fed state (Cmax_fed)

  Up to 3 days

• Area under the concentration-time curve of selitrectinib in plasma from time 0 to 24 hours in fed state (AUC(0-24)_fed)

  Up to 1 days

• Area under the concentration-time curve of selitrectinib in plasma from time 0 to infinity in fed state (AUC_fed)

  Up to 3 days

Secondary Outcomes (1)

• Number of participants with treatment-emergent adverse events (TEAEs)

  Up to 23 weeks

Study Arms (3)

Arm_25 + 75 mg (Fasted)

EXPERIMENTAL

Healthy male participants receive a single dose of 25 mg selitrectinib (Period 1) and 75 mg selitrectinib (Period 2) in fasted state.

Drug: Selitrectinib (BAY2731954)

Arm_50 + 50 mg (Fasted/Fed)

EXPERIMENTAL

Healthy male participants receive a single dose of 50 mg selitrectinib in fasted state (Period 1) and 50 mg selitrectinib in fed state (Period 2).

Drug: Selitrectinib (BAY2731954)

Arm_100 + 150 mg (Fasted)

EXPERIMENTAL

Healthy male participants receive a single dose of 100 mg selitrectinib (Period 1) and 150 mg selitrectinib (Period 2) in fasted state.

Drug: Selitrectinib (BAY2731954)

Interventions

Selitrectinib (BAY2731954) DRUG

Selitrectinib is administered orally as liquid suspension (20 mg/mL) on Day 1 of each period. Each period lasts 4 days, both periods of each arm are separated by at least 3 days.

Also known as: Tyrosine receptor kinase (TRK) inhibitor

Arm_100 + 150 mg (Fasted); Arm_25 + 75 mg (Fasted); Arm_50 + 50 mg (Fasted/Fed)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• 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 (1)

CRS Clinical-Research-Services Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

MeSH Terms

Interventions

selitrectinib; Receptor Protein-Tyrosine Kinases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 19, 2020
• Study Start: February 28, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 30, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

DE (1)