US-based pharmaceutical firm Lipocine has dosed the first patient in a Phase I trial of LPCN 1107, an oral hydroxyprogesterone caproate (HPC) product candidate, for preventing preterm birth in pregnant women.
The trial’s primary objectives will be to determine safety, tolerability and pharmacokinetics of oral administration of LPCN 1107 in pregnant women.
The open-label Phase I trial will enrol around eight healthy, pregnant females of child bearing age with a normal pregnancy of 16 to 18 weeks.
In period one, these females will be given two doses of 400mg oral LPCN 1107, administered 12 hours apart, while in second period they will receive two doses of 800mg oral LPCN 1107, administered 12 hours apart.
The third period will see subjects receiving 250mg of HPC through intramuscular injection.
The company said that there will be a washout period of at least three days between each period.
Blood samples of these subjects will be taken and used to determine the pharmacokinetics for each period.
Lipocine president and CEO Dr Mahesh Patel said: "Based on previous clinical testing, we believe that LPCN 1107 has the potential to become the first oral product for prevention of preterm birth.
"HPC is the only drug approved for prevention of recurrent preterm birth, a leading cause of perinatal mortality and morbidity worldwide, but it is currently only available in an inconvenient injectable form that may cause pain at the site of injection and requires several visits to the physician during the course of treatment.
The company intends to report top-line results from the study in 2015.
In the previous Phase I clinical testing, LPCN 1107 was well tolerated and achieved meaningful drug levels after oral administration in healthy, non-pregnant women.
According to the company, LPCN 1107 has the potential to become the first oral HPC product to prevent preterm birth in women with a prior history of at least one preterm birth.