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NCT05581758
A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Phase 1 trial testing AMG 510 in Healthy Participants in 14 participants. Completed in 9 December 2019.
25 November 2019
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 14 |
| Start date | 14 November 2019 |
| Primary completion | 25 November 2019 |
| Estimated completion | 9 December 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- AMG 510 — full drug profile →
Conditions studied
- Healthy Participants — all drugs for Healthy Participants →
Sponsor
Amgen — full company profile →
Who can join
Adults 18 to 60, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of the study is to evaluate the PK of AMG 510 administered in the fasted and fed state in healthy participants.
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 NCT05581758
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AMG 510
Trials testing the same drug.
- NCT05180422 — A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C · Phase 1, PHASE2 · withdrawn
- NCT05118854 — A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Res · Phase 2 · recruiting
- NCT05599828 — A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants · Phase 1 · completed
- NCT04303780 — Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). · Phase 3 · active not recruiting
- NCT04380753 — AMG 510 Ethnic Sensitivity Study (CodeBreaK 105). · Phase 1 · completed
Other recruiting trials for Healthy Participants
Currently open trials in the same condition.
- NCT07469085 — A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Partici · Phase 1 · recruiting
- NCT07503990 — Effects of Food Intake Sequence on Substrate Utilisation and Endurance Performance · NA · recruiting
- NCT07474987 — Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury · recruiting
- NCT07511205 — A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participa · Phase 1 · recruiting
- NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
Other Amgen trials
Trials by the same sponsor.
- NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
- NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
- NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
- NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
- NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · 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 NCT05581758 (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 Amgen
- Last refreshed: 5 March 2025
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/NCT05581758.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing