14C PGL4001 Mass Balance Study in Healthy Female Subjects

• Research type

  Research Study

• Full title

  An Open Label, Single-Dose, Study in Healthy Female Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C PGL4001

• IRAS ID

  45744

• Contact name

  Ashley Brooks

• Sponsor organisation

  Preglem SA

• Eudract number

  2009-017379-20

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  PregLem SA is developing the compound (code name: PGL4001) for benign gynaecological indications including uterine myoma. PGL4001 belongs to the class of Selective Progesterone Receptor Modulators (SPRMs). It acts by blocking the progesterone receptor in its target tissues (uterus, cervix, ovaries, hypothalamus) which can be reversed if needed. Uterine myomas are benign and most common tumours of the female reproductive tract in pre-menopausal women and affecting approximately 40% of women between 35 and 55 years. When symptomatic, the cardinal symptoms are heavy uterine bleeding, anaemia, abdominal pressure, abdominal pain, increased frequency and infertility. The aim of this Phase I study is to assess the mass balance recovery, metabolic profile and metabolite identification of 14C-PGL4001 in healthy female subjects following a single oral dose. Of note, current clinical exposure in completed studies with PGL4001 tablets includes 4751 healthy volunteers and patients exposed to single dose of up to 200 mg, and 95 exposed to multiple dose testing up to 24 weeks (up to 20mg) and up to 50 mg (6 weeks) without any indications of toxicity. Two Phase III studies repeated dose are on-going. Therefore, 6 healthy sterilised women, 25 to 55 years of age, will be participating in this study. This will be an open-label, single oral dose study. Each subject will reside at the CRU from Day -1 (the day before dosing) until at least Day 8 (168 hours post-dose). On day 8, the subjects will be allowed to leave the clinic if the detection of the parent drug and its breakdown product is more than 90% in total or less than 1% is recovered in urine on two consecutive days. These collections will continue up to 216 hours post-dose (Day 10), if discharge criteria are not met. The expected duration of subject participation is approximately 7 weeks.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/1

• Date of REC Opinion

  22 Feb 2010

• REC opinion

  Further Information Favourable Opinion