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NCT04771390 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Solid Tumors Harboring NTRK Fusion, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 2
- Study locations
NCT04771390: Completed Phase 1 study of Solid Tumors Harboring NTRK Fusion, sponsored by Bayer.
NCT04771390 is a Phase 1 study of Solid Tumors Harboring NTRK Fusion that has completed, run by Bayer. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04771390, a Phase 1 study of Solid Tumors Harboring NTRK Fusion, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Selitrectinib (BAY2731954) Adult tablet
- DRUG Selitrectinib (BAY2731954) Pediatric tablet
- DRUG Selitrectinib (BAY2731954) Oral solution
- DRUG Selitrectinib (BAY2731954) Oral suspension
Study Locations (2)
California
- Parexel International - Los Angeles - Glendale
Maryland
- PAREXEL International, Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2021-07-06 |
| Phase | Phase 1 |
What the finished NCT04771390 record still lists
NCT04771390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Solid Tumors Harboring NTRK Fusion appearing as the primary indexed condition, and to 4 interventions - of which Selitrectinib (BAY2731954) Adult tablet is the first listed.
NCT04771390 reports a single indexed study location in California, Maryland.
Frequently Asked Questions
What is clinical trial NCT04771390 about?
NCT04771390 is a clinical study titled "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". 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, distr...
What is the current status of trial NCT04771390?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2021-02-16. Estimated completion is 2021-07-06.
What conditions does trial NCT04771390 study?
This clinical trial studies the following conditions: Solid Tumors Harboring NTRK Fusion.
What interventions are being tested in trial NCT04771390?
The interventions under investigation include: Selitrectinib (BAY2731954) Adult tablet (DRUG), Selitrectinib (BAY2731954) Pediatric tablet (DRUG), Selitrectinib (BAY2731954) Oral solution (DRUG), Selitrectinib (BAY2731954) Oral suspension (DRUG).
Who is sponsoring clinical trial NCT04771390?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04771390 being conducted?
This trial has 2 study locations across California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04771390's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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