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NCT06061523
A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants
Phase 1 trial testing Sotorasib in Healthy Participants. Withdrawn.
9 September 2024
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Start date | 15 July 2024 |
| Primary completion | 9 September 2024 |
| Estimated completion | 9 September 2024 |
Drugs / interventions tested
- Sotorasib (SOTORASIB) — 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 objectives of the study are to compare the pharmacokinetics (PK) and demonstrate relative bioavailability of sotorasib administered as 4 oral tablets (test) to sotorasib administered as 8 oral tablets (reference) and to assess the effect of food on the PK of sotorasib administered as 4 oral tablets.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06061523
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sotorasib
Trials testing the same drug.
- NCT07012031 — Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell · Phase 1, PHASE2 · recruiting
- NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer · EARLY_PHASE1 · not yet recruiting
- NCT07172919 — A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation · Phase 2 · recruiting
- NCT07143513 — Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients · completed
- NCT06804824 — A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid T · Phase 1 · recruiting
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
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- 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 NCT06061523 (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: 12 April 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/NCT06061523.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing