Trial Profile
A Phase I, Single Centre, Randomised, Open Label, Crossover Study to Assess the Bioequivalence or Relative Bioavailability of Variants of Selumetinib (AZD6244, Hyd-Sulfate) Blue Capsules in Healthy Male Volunteers Aged 18 to 45 Years
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 06 Nov 2021
Price :
$35
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At a glance
- Drugs Selumetinib (Primary)
- Indications Acute myeloid leukaemia; Astrocytoma; Biliary cancer; Colorectal cancer; Glioma; Liver cancer; Malignant melanoma; Multiple myeloma; Non-small cell lung cancer; Pancreatic cancer; Solid tumours; Thyroid cancer; Uveal melanoma
- Focus Pharmacokinetics
- Sponsors AstraZeneca
- 23 Aug 2017 Results of pooled population PK analysis using a non-linear mixed effects approach with plasma concentration data from n=346 subjects who received single oral doses of selumetinib 20-75 mg across ten Phase I studies (NCT01635023, NCT01974349, NCT02056392, NCT02063204, NCT02063230, NCT02093728, NCT02046850, NCT01960374, NCT02322749 and NCT02238782) published in the British Journal of Clinical Pharmacology
- 10 Mar 2017 Results of pooled analysis of ten phase I studies including this study published in the European Journal of Clinical Pharmacology
- 11 Oct 2016 Results of pooled analysis of PK data from this and other 9 trials ( NCT01635023, NCT01974349, NCT02056392, NCT02238782, NCT02063204, NCT02063230, NCT02093728, NCT02046850, NCT01960374) presented at the 41st European Society for Medical Oncology Congress