PD37-08 EFFICACY AND PHARMACOKINETICS OF LPCN 1021, A NOVEL ORAL TESTOSTERONE REPLACEMENT THERAPY (TRT), IN HYPOGONADAL MEN: STUDY OF ANDROGEN REPLACEMENT (SOAR) (2015)

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Non-Surgical Therapy I1 Apr 2015PD37-08 EFFICACY AND PHARMACOKINETICS OF LPCN 1021, A NOVEL ORAL TESTOSTERONE REPLACEMENT THERAPY (TRT), IN HYPOGONADAL MEN: STUDY OF ANDROGEN REPLACEMENT (SOAR) Jed C. Kaminetsky, Anthony DelConte, Adrian S. Dobs, Christina Wang, Pavan Yadav, Srinivasan Venkateshwaran, Nachiappan Chidambaram, Satish Nachaegari, Mahesh Patel, and Martin M. Miner Jed C. KaminetskyJed C. Kaminetsky More articles by this author , Anthony DelConteAnthony DelConte More articles by this author , Adrian S. DobsAdrian S. Dobs More articles by this author , Christina WangChristina Wang More articles by this author , Pavan YadavPavan Yadav More articles by this author , Srinivasan VenkateshwaranSrinivasan Venkateshwaran More articles by this author , Nachiappan ChidambaramNachiappan Chidambaram More articles by this author , Satish NachaegariSatish Nachaegari More articles by this author , Mahesh PatelMahesh Patel More articles by this author , and Martin M. MinerMartin M. Miner More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2270AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES TRT is indicated for treating hypogonadal men with low serum testosterone (T) levels and related symptoms. However, T products administered as topical or depot formulations are associated with inadvertent T transfer, messy application, poor retention rates, and superphysiologic T levels in some patients. There is a need for T formulations that are more user friendly, limit blood level dose excursions, and avoid T transdermal transfer. LPCN 1021 is a novel oral T undecanoate formulation being assessed in a Phase 3 trial that may avoid some of the undesirable attributes of non-oral T formulations. METHODS SOAR is a randomized, active-controlled, 2-arm, 12-month, open-label, multicenter, dose-titration trial that included 18- to 80-year-old hypogonadal (T <300 ng/dL on 2 separate days) men. Participants were randomized to either oral LPCN 1021 (n=210) or T gel 1.62% (n=105). The starting dose was 225 mg LPCN 1021 BID taken with a meal. The dose could be titrated up (eg, if T Cave,24h <300 mg/dL) or down (eg, if T Cmax was >1500 mg/dL) at weeks 4 and 8 based on 24 h PK. Efficacy was assessed on week 13 based on T Cave,24h from serum samples collected over 24 h for T assayed by LC-MS/MS. Analysis was conducted using the Efficacy Population Set (subjects with ≥1 PK profile and no significant protocol deviations; N=152 LPCN 1021). RESULTS LPCN 1021 reliably restored and maintained T levels in the eugonadal range (300-1140 ng/dL) in 88% of hypogonadal men (lower bound 95% CI=81.9%). Mean T Cave,24h value was 447±166 ng/dL, consistent with other non-oral TRT therapies. There was no significant dose timing effect (eg, AM vs PM), suggesting consistent intra-day performance. Overall variability was low (37% CV for Cave,24h). 82.9% of subjects had serum T peak (Cmax) <1500 ng/dL, <5% had Cmax 1800-2500 ng/dL, and only 2% had serum T levels >2500 ng/dL, and those cases were sporadic, transient, and isolated, with no associated clinical events. 85% of subjects required ≤1 dose adjustment, suggesting a safe and effective titration algorithm. CONCLUSIONS LPCN 1021 is an orally administered TRT product with acceptable Cave and Cmax excursions, consistent with US FDA targets met by other non-oral TRT products. LPCN 1021 may improve patient adherence as a generally safe, effective, and more convenient option compared to topical, transdermal, injectable, or implanted TRT products. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e773 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jed C. Kaminetsky More articles by this author Anthony DelConte More articles by this author Adrian S. Dobs More articles by this author Christina Wang More articles by this author Pavan Yadav More articles by this author Srinivasan Venkateshwaran More articles by this author Nachiappan Chidambaram More articles by this author Satish Nachaegari More articles by this author Mahesh Patel More articles by this author Martin M. Miner More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...