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No clinically relevant drug–drug interactions when dalcetrapib is co-administered with a monophasic oral contraceptive (Microgynon® 30)
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Young, Annie M., Anzures-Cabrera, Judith and Derks, Michael (2010) No clinically relevant drug–drug interactions when dalcetrapib is co-administered with a monophasic oral contraceptive (Microgynon® 30). International Journal of Clinical Pharmacology and Therapeutics, 50 (04). pp. 248-256. doi:10.5414/CP201647 ISSN 0946-1965.
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Official URL: http://dx.doi.org/10.5414/CP201647
Abstract
Objectives: Dalcetrapib, which targets cholesteryl ester transfer protein, is in clinical development for prevention of cardiovascular events and is likely to be used concomitantly with statins. Two studies investigated co-administration of dalcetrapib with atorvastatin and any effects of the timing of atorvastatin on the pharmacokinetics of dalcetrapib. Research design and methods: Two crossover studies were performed in healthy subjects: a two-period study of dalcetrapib 900 mg concurrently with atorvastatin (concurrent dosing study) and a three-period study of dalcetrapib 600 mg (dose chosen for Phase III) with atorvastatin concurrently or serially 4 h after dalcetrapib (interval dosing study). Main outcome measures: The primary pharmacokinetic end points were AUC0 24 and Cmax; lipid effects and tolerability were secondary end points. Results: In the concurrent study (n 26), co-administration reduced dalcetrapib AUC0 24 and Cmax and caused small changes in AUC0 24 and Cmax of atorvastatin and its active metabolites. In the interval study (n 52), serial and concurrent co-administration of atorvastatin resulted in similar reductions in dalcetrapib exposure that were comparable to those observed in the concurrent dosing study. Co-administration did not decrease the efficacy of dalcetrapib or atorvastatin and was generally well tolerated. Conclusions: These results indicate no clinically relevant interactions for co-administration of dalcetrapib with atorvastatin. © 2010 Informa UK, Ltd.
| Item Type: | Journal Article | ||||
|---|---|---|---|---|---|
| Subjects: | R Medicine > R Medicine (General) | ||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Journal or Publication Title: | International Journal of Clinical Pharmacology and Therapeutics | ||||
| Publisher: | Dustri Verlag | ||||
| ISSN: | 0946-1965 | ||||
| Official Date: | 26 August 2010 | ||||
| Dates: |
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| Volume: | 50 | ||||
| Number: | 04 | ||||
| Page Range: | pp. 248-256 | ||||
| DOI: | 10.5414/CP201647 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
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