SALT LAKE CITY, UT, USA I May 27, 2014 I Lipocine Inc. (LPCN), a specialty pharmaceutical company, today announced that the first patient has been dosed in a Phase 2a clinical study of LPCN 1111, a novel ester prodrug of testosterone, in hypogonadal males. The primary objectives of the study will be to determine safety, tolerability, single and steady state pharmacokinetics of testosterone following oral administration of LPCN 1111.
“Based on Phase 1 clinical data, we believe that LPCN 1111 has the potential to be a once a day oral testosterone replacement therapy or provide high average testosterone levels while limiting supraphysiological levels with a twice a day dosing regimen,” said Dr. Mahesh Patel, President and CEO of Lipocine Inc. “We look forward to reporting top-line results from this study in the second half of 2014 which would become the basis for our Phase 2b study in hypogonadal males.”
This 12 patient open-label pharmacokinetic study includes a single ascending dose followed by a fixed dose steady state arm in males between the age of 18 and 80, with documented onset of hypogonadism prior to age 65. These subjects must have serum total testosterone
LPCN 1111 is a next-generation, novel ester prodrug of testosterone, being developed as a possible testosterone replacement treatment. LPCN 1111 uses the Company’s Lip’ral technology to enhance solubility and improve systemic absorption. Previous clinical data suggested feasibility of either once or twice daily dosing.
About Lipocine
Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s lead product candidate, LPCN 1021, currently in Phase 3 and is targeted to treat symptoms of low testosterone for men in need of testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth.
SOURCE: Lipocine
Post Views: 433
SALT LAKE CITY, UT, USA I May 27, 2014 I Lipocine Inc. (LPCN), a specialty pharmaceutical company, today announced that the first patient has been dosed in a Phase 2a clinical study of LPCN 1111, a novel ester prodrug of testosterone, in hypogonadal males. The primary objectives of the study will be to determine safety, tolerability, single and steady state pharmacokinetics of testosterone following oral administration of LPCN 1111.
“Based on Phase 1 clinical data, we believe that LPCN 1111 has the potential to be a once a day oral testosterone replacement therapy or provide high average testosterone levels while limiting supraphysiological levels with a twice a day dosing regimen,” said Dr. Mahesh Patel, President and CEO of Lipocine Inc. “We look forward to reporting top-line results from this study in the second half of 2014 which would become the basis for our Phase 2b study in hypogonadal males.”
This 12 patient open-label pharmacokinetic study includes a single ascending dose followed by a fixed dose steady state arm in males between the age of 18 and 80, with documented onset of hypogonadism prior to age 65. These subjects must have serum total testosterone
LPCN 1111 is a next-generation, novel ester prodrug of testosterone, being developed as a possible testosterone replacement treatment. LPCN 1111 uses the Company’s Lip’ral technology to enhance solubility and improve systemic absorption. Previous clinical data suggested feasibility of either once or twice daily dosing.
About Lipocine
Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s lead product candidate, LPCN 1021, currently in Phase 3 and is targeted to treat symptoms of low testosterone for men in need of testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth.
SOURCE: Lipocine
Post Views: 433
