NCT04118842 is a Phase 1 clinical trial of Savolitinib in Solid Tumors, sponsored by AstraZeneca.

Who is sponsoring NCT04118842?

NCT04118842 is sponsored by AstraZeneca.

What drugs are being tested in NCT04118842?

Interventions in NCT04118842: Savolitinib, Rifampicin.

What condition does NCT04118842 study?

NCT04118842 studies Solid Tumors.

Is NCT04118842 still recruiting?

NCT04118842 is currently completed. Last updated 3 April 2020.

Last reviewed 2020-04-03 · How we verify

NCT04118842

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

A Study in Healthy Subjects to Assess the Pharmacokinetics of Savolitinib When Administered Alone and in Combination With Rifampicin

Completed Phase 1 Last updated 3 April 2020

What this trial tests

Phase 1 trial testing Savolitinib in Solid Tumors in 40 participants. Completed in 26 February 2020.

Timeline

17 October 2019

Primary endpoint
26 February 2020

26 February 2020

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	basic science
Enrollment	40
Start date	17 October 2019
Primary completion	26 February 2020
Estimated completion	26 February 2020
Sites	1 location across United States

Drugs / interventions tested

Savolitinib — full drug profile →
Rifampicin (Rifampicin) — full drug profile →

Conditions studied

Solid Tumors — all drugs for Solid Tumors →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 65, male only, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I, open-label, 3 treatment period, fixed-sequence study in healthy non-Japanese male subjects, aged 18 to 65 years (inclusive), performed at a single study centre. Treatment Period 1 will establish the single dose pharmacokinetic (PK) profile of savolitinib. Dosing of daily rifampicin during Treatment Period 2 will result in maximal induction of the CYP450 enzymes including CYP3A4. Treatment Period 3 will then establish the single dose PK profile of savolitinib under maximum CYP450 induction conditions. Comparison of the PK profile of savolitinib between Treatment Period 1 and Treatment Period 3 will quantify the effect of CYP450 enzyme induction.

Publications & conference data

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

Clinical evaluation of the potential drug-drug interactions of savolitinib: Interaction with rifampicin, itraconazole, famotidine or midazolam.
Ren S, Vishwanathan K, Cantarini M, Frewer P, et al · · 2022 · cited 9× · PMID 34322894 · DOI 10.1111/bcp.14994
Oncogenic mechanism-based pharmaceutical validation of therapeutics targeting MET receptor tyrosine kinase.
Yao HP, Tong XM, Wang MH. · · 2021 · cited 7× · PMID 33868463 · DOI 10.1177/17588359211006957

Verify or expand the search:

Other trials of Savolitinib

Trials testing the same drug.

NCT06692491 — Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS · Phase 2 · not yet recruiting
NCT06563999 — Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. · Phase 2 · recruiting
NCT06348355 — A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers · Phase 1 · completed
NCT05777278 — Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression · Phase 1, PHASE2 · recruiting
NCT05888207 — A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects · Phase 1 · completed

Other recruiting trials for Solid Tumors

Currently open trials in the same condition.

NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · 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 NCT04118842 (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 AstraZeneca
Last refreshed: 3 April 2020

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/NCT04118842.

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