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NCT05888207
A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects
Phase 1 trial testing Savolitinib in Healthy Male Subjects in 16 participants. Completed in 17 August 2023.
17 August 2023
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | other |
| Enrollment | 16 |
| Start date | 2 June 2023 |
| Primary completion | 17 August 2023 |
| Estimated completion | 17 August 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Savolitinib — full drug profile →
- Fluvoxamine (FLUVOXAMINE) — full drug profile →
Conditions studied
- Healthy Male Subjects — all drugs for Healthy Male Subjects →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 55, male only, with Healthy Male Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will assess the effects of strong CYP1A2 (Cytochrome P450 1A2) inhibitor (fluvoxamine) on savolitinib exposure in healthy male subjects, performed at a single clinical unit.
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:
- PubMed search for NCT05888207
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Savolitinib
Trials testing the same drug.
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- 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
- NCT05768360 — A Study to Assess the Effects of Savolitinib on the Pharmacokinetics of Digoxin, Rosuvastatin, Metformin, and Furosemide · Phase 1 · completed
Other recruiting trials for Healthy Male Subjects
Currently open trials in the same condition.
- NCT07340476 — A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects · Phase 1 · active not 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)
- Trial protocol + status: ClinicalTrials.gov NCT05888207 (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 AstraZeneca
- Last refreshed: 29 August 2023
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/NCT05888207.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing