Last reviewed · How we verify
NCT05571163
A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Participants
Phase 1 trial testing AMG 510 in Healthy Participants in 13 participants. Completed in 14 June 2020.
14 June 2020
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 13 |
| Start date | 6 March 2020 |
| Primary completion | 14 June 2020 |
| Estimated completion | 14 June 2020 |
| 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 55, 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 pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion 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 NCT05571163
- 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AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C · Phase 1, PHASE2 · withdrawn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 NCT05571163 (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: 7 October 2022
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/NCT05571163.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing