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No clinically relevant drug–drug interactions when dalcetrapib is co-administered with atorvastatin
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Derks, Michael, Abt, Markus, Parr, Graeme, Meneses-Lorente, Georgina, Young, Annie M. and Phelan, Mary (2010) No clinically relevant drug–drug interactions when dalcetrapib is co-administered with atorvastatin. Expert Opinion on Investigational Drugs, 19 (10). pp. 1135-1145. doi:10.1517/13543784.2010.509342 ISSN 1354-3784.
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Official URL: http://dx.doi.org/10.1517/13543784.2010.509342
Abstract
Dalcetrapib, a cholesteryl ester transfer protein modulator, under development to increase high-density lipoprotein cholesterol and potentially decrease cardiovascular risk, will potentially be co-prescribed to women on oral contraceptive (OC). Objective: Assess the effect of dalcetrapib on the pharmacokinetics and ability to suppress ovulation of Microgynon® 30, a representative monophasic OC. Materials and methods: A single-center, randomized, open-label, two-period crossover study in healthy women receiving monophasic OC. Subjects received Microgynon® 30 (ethinylestradiol 0.03 mg/levonorgestrel 0.15 mg) once daily for 21 days followed by 7 treatment-free days (run-in period), then were randomized to Microgynon® 30 daily for 21 days with or without dalcetrapib 900 mg daily for Day 1 - 14. Plasma ethinylestradiol and levonorgestrel were measured on Day 14, and luteinizing hormone, follicle stimulating hormone, progesterone and estrogen from Day 11 - 14. The primary endpoint plasma exposure (AUC 0-24and C max) on Day 14 was evaluated for ethinylestradiol and levonorgestrel. Safety was monitored throughout. Results: 30 subjects were randomized. The exposure of ethinylestradiol and levonorgestrel was similar when Microgynon® 30 was administered with or without dalcetrapib; for ethinylestradiol the geometric mean ratio %, (90% confidence interval (CI)) for AUC0-24 and C max were 92 (86 - 98) and 105 (95 - 115) and for levonorgestrel 92 (88 - 96) and 93 (87 - 99), respectively. Concentrations of luteinizing hormone, follicle stimulating hormone, estrogen and progesterone were comparable between treatments. Conclusions: Dalcetrapib has no clinically relevant effect on the pharmacokinetics of ethinylestradiol and levonorgestrel. Contraceptive efficacy of Microgynon® 30 is not anticipated to be compromised by co-administration of dalcetrapib. ©2012 Dustri-Verlag Dr. K. Feistle.
| 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: | Expert Opinion on Investigational Drugs | ||||
| Publisher: | Routledge | ||||
| ISSN: | 1354-3784 | ||||
| Official Date: | 1 April 2010 | ||||
| Dates: |
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| Volume: | 19 | ||||
| Number: | 10 | ||||
| Page Range: | pp. 1135-1145 | ||||
| DOI: | 10.1517/13543784.2010.509342 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
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