PK Evaluation of Topical Formulations of ABT-SLV176 (QBR113819)

• Research type

  Research Study

• Full title

  Phase I Formulation Development and Clinical Pharmacokinetic Evaluation of New Topical Formulations of ABT-SLV176 (Testosterone Gel) In Healthy Postmenopausal Females.

• IRAS ID

  123954

• Contact name

  Stuart Mair

• Sponsor organisation

  AbbVie GmbH & Co KG

• Eudract number

  2012-005479-15

• ISRCTN Number

  To be registered

• Research summary

  The purpose of the study is to compare how different gel formulations of the study drug, ABT-SLV176, are taken up by the body when applied to the skin, compared to a formulation that's equivalent to the currently marketed product AndroGel©. The drug is in the form of a topical gel and is to be applied to either the shoulders/upper arms or the armpits.ABT-SLV176 is a gel containing testosterone, and is being developed for males with reduced testosterone levels caused by hypogonadism (diminished ability of the testis to produce testosterone). In this study, the drug will be tested in post-menopausal females, as natural testosterone levels are very low and will allow the testosterone that's taken up by the body to be measured easily. There will be 4 cohorts of subjects (A1, A2, B1 and B2). Subjects in cohorts A1 and A2 will have ABT-SLV176 applied to both underarms (armpits). Subjects in Cohorts B1 and B2 will have ABT-SLV176 applied to both upper arms/shoulders. Each subject will receive a reference treatment (a 1.62% testosterone gel, equivalent to AndroGel©) and three further formulations of 2.2% testosterone gel administered on separate occasions.

• REC name

  Wales REC 1

• REC reference

  13/WA/0029

• Date of REC Opinion

  19 Feb 2013

• REC opinion

  Further Information Favourable Opinion