First in Man study of MIV-711, safety, PK and PD/ascending SAD/MAD

• Research type

  Research Study

• Full title

  First in Man Study of MIV-711 - Safety, Pharmacokinetics and Pharmacodynamics of Oral Ascending Single and Multiple Doses in Healthy Subjects

• IRAS ID

  96622

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Medivir AB

• Eudract number

  2011-003024-12

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  MIV-711 is a new drug being developed for the treatment of osteoporosis (thinning of the bones)which primarily affects post menopausal women. This study will be the first time that the study drug will be given to humans. The study is a double-blind, placebo-controlled, ascending single and multiple oral dose study conducted in two parts. Part 1 will involve administration of single ascending doses to up to four treatment groups to investigate the safety, tolerability and study drug levels in the blood as well as the effect of food on the study drug levels in one treatment for one group. In part 2, subjects will be dosed once to four times daily for up to 14 days to investigate the safety, tolerability and study drug levels in the blood after multiple doses. A further goup of post menopausal women (the population mostly likely to be treated with the study drug) will be dosed once daily for 14 days to assess safety, tolerability and study drug levels in the blood. All subjects will be aged between 18 and 65 years. All doses will be administered orally. In both parts following review of data from earlier groups, it is intended that the dose level will increase between each group.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0134

• Date of REC Opinion

  27 Apr 2012

• REC opinion

  Further Information Favourable Opinion