Who is sponsoring NCT04771390?

NCT04771390 is sponsored by Bayer.

What drugs are being tested in NCT04771390?

Interventions in NCT04771390: Selitrectinib (BAY2731954) Adult tablet, Selitrectinib (BAY2731954) Pediatric tablet, Selitrectinib (BAY2731954) Oral solution, Selitrectinib (BAY2731954) Oral suspension.

What condition does NCT04771390 study?

NCT04771390 studies Solid Tumors Harboring NTRK Fusion.

Is NCT04771390 still recruiting?

NCT04771390 is currently completed. Last updated 25 August 2021.

Last reviewed 2021-08-25 · How we verify

NCT04771390

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 25 August 2021

What this trial tests

Phase 1 trial testing Selitrectinib (BAY2731954) Adult tablet in Solid Tumors Harboring NTRK Fusion in 52 participants. Completed in 6 July 2021.

Timeline

16 February 2021

Primary endpoint
20 May 2021

6 July 2021

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	52
Start date	16 February 2021
Primary completion	20 May 2021
Estimated completion	6 July 2021
Sites	2 locations across United States

Drugs / interventions tested

Selitrectinib (BAY2731954) Adult tablet — full drug profile →
Selitrectinib (BAY2731954) Pediatric tablet — full drug profile →
Selitrectinib (BAY2731954) Oral solution
Selitrectinib (BAY2731954) Oral suspension

Conditions studied

Solid Tumors Harboring NTRK Fusion — all drugs for Solid Tumors Harboring NTRK Fusion →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 55, any sex, with Solid Tumors Harboring NTRK Fusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Solid Tumors Harboring NTRK Fusion

Currently open trials in the same condition.

NCT07394374 — A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTR · Phase 1, PHASE2 · recruiting
NCT02637687 — A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Childr · Phase 1, PHASE2 · active not recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04771390 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 25 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04771390.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing