Trial reportClinical pharmacokinetics2012
Vinflunine oral pharmacokinetics and absolute bioavailability of soft and hard gelatin capsules: results of two phase I trials.
Trial report in Clinical pharmacokinetics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVinflunine is a new-generation microtubule inhibitor, which is currently registered in Europe and in some countries elsewhere as an intravenous formulation for the second-line treatment of transitional urothelial cell carcinoma. On the basis of favourable non-clinical results, the clinical development of an oral formulation was initiated.
objectiveThe absolute oral bioavailability was investigated in patients through two consecutive trials: the first trial used soft gelatin capsules filled with solubilized vinflunine (SLCaps), while the second study investigated hard gelatin capsules containing vinflunine as a formulated powder (HPCaps). STUDY
designEach pharmacokinetic trial was conducted according to a randomized cross-over design. Patients received 120 mg/m2 of either oral (SLCaps or HPCaps) or intravenous vinflunine on day 1, followed by the alternate dosing route after a 2-week washout period. Blood samples were collected over 168 hours. A pharmacokinetic analysis was conducted for each patient and route of dosing to derive the absolute oral bioavailability of SLCaps and HPCaps.
resultsA total of 12 and 22 patients were enrolled, for SLCaps and HPCaps, respectively. Vinflunine absorption was rapid for both oral formulations. Blood concentrations peaked at 2.5 hours following oral intake with food, and then decreased similarly to the intravenous profile. The mean absolute bioavailability was high, at 58.3 ± 14.4% (SLCaps) and 57.3 ± 11% (HPCaps), with limited inter-individual variability (coefficient of variation = 25% and 19% for SLCaps and HPCaps, respectively). Neither sequence nor period effects were detected. The gastro-intestinal tolerance was satisfactory. The main drug-related adverse events were asthenia, fatigue, constipation and neutropenia, mostly of grade 1 or 2. No grade 4 and no drug-related serious adverse events were reported.
conclusionThe high bioavailability and low inter-individual variability are favourable pharmacokinetic properties, which could be valuable for further clinical development of oral vinflunine.
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