NCT05490030 is a Phase 1 clinical trial of TNO155 in Hepatic Impairment, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT05490030?

NCT05490030 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT05490030?

Interventions in NCT05490030: TNO155.

What condition does NCT05490030 study?

NCT05490030 studies Hepatic Impairment.

Is NCT05490030 still recruiting?

NCT05490030 is currently withdrawn. Last updated 29 February 2024.

Last reviewed 2024-02-29 · How we verify

NCT05490030

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

Pharmacokinetics of TNO155 in Participants With Mild, Moderate, or Severe Hepatic Impairment Compared to Matched Healthy Participants

Withdrawn Phase 1 Last updated 29 February 2024

What this trial tests

Phase 1 trial testing TNO155 in Hepatic Impairment. Withdrawn.

Timeline

6 March 2025

Primary endpoint
26 June 2025

26 June 2025

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Start date	6 March 2025
Primary completion	26 June 2025
Estimated completion	26 June 2025

Drugs / interventions tested

TNO155 — full drug profile →

Conditions studied

Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the effect of various degrees of hepatic impairment on plasma pharmacokinetics (PK), safety and tolerability of TNO155. The results of this study will guide the Novartis recommendation regarding whether or not a dose adjustment may be needed when treating patients with hepatic impairment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
RAS Pathway Inhibitors Combined with Targeted Agents Are Active in Patient-Derived Spheroids with Oncogenic KRAS Variants from Multiple Cancer Types.
Davoudi Z, Dexheimer TS, Coussens NP, Silvers T, et al · · 2025 · PMID 40960119 · DOI 10.1158/2767-9764.crc-24-0582

Verify or expand the search:

Other trials of TNO155

Trials testing the same drug.

NCT07468071 — Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agen · Phase 1, PHASE2 · not yet recruiting
NCT05541159 — Pharmacokinetics Study of TNO155 in Participants With Mild, Moderate, or Severe Renal Impairment Compared to Matched Hea · Phase 1 · withdrawn
NCT04699188 — Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation · Phase 1, PHASE2 · active not recruiting
NCT04294160 — A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer · Phase 1 · terminated
NCT04292119 — Lorlatinib Combinations in Lung Cancer · Phase 1, PHASE2 · unknown

Other recruiting trials for Hepatic Impairment

Currently open trials in the same condition.

NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · 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 NCT05490030 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 29 February 2024

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/NCT05490030.

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