PK study of Testosterone, Testosterone Undecanoate and Metabolites
Research type
Research Study
Full title
A Two Part Phase 1 Study of Selected Oral Prototype Formulations of Testosterone Undecanoate in Healthy Postmenopausal Women, to Evaluate the Pharmacokinetics of Testosterone and Testosterone Undecanoate and Their Major Metabolites, and the Effect of Food.
IRAS ID
163385
Contact name
Ann Fullerton
Contact email
Sponsor organisation
Solural Pharma ApS
Eudract number
2014-003525-17
Research summary
The Sponsor is developing new oral formulations of the study drug, testosterone undecanoate, for the potential treatment of male hypogonadism. \n\nThe study will try to identify the difference in how the study drug is taken up by the body when various formulations are given as either hard gelatin capsules or as porous tablets, and the effect of food on the uptake of the study drug by the body. \n\nThe study will consist of 2 parts involving up to 52 post-menopausal female subjects. In Part 1a, 16 subjects will each receive each of the 6 following study regimens (treatment legs) in turn:\n \n- Regimen 1: 80mg formulation prototype A (capsule) given as 2 x 40mg capsules without food;\n- Regimen 2: 80mg formulation prototype A (tablet) given as 2 x 40mg tablets without food;\n- Regimen 3: 40-160mg formulation prototype B given as 1-4 x 40mg dose units, either with or without food \n- Regimen 4: 40-160mg formulation prototype C given as 1-4 x 40mg dose units, either with or without food; \n- Regimen 5: 40-160mg formulation prototype D given as 1-4 x 40mg dose units, either with or without food;\n- Regimen 6: 40-160mg formulation prototype E given as 1-4 x 40mg dose units, either with or without food\n\nIn part 1b, 16 volunteers (minimum, up to 36 maximum) will each receive each of the 4 study regimens in turn, given as 1-4 x 40mg dose units:\n \n- Regimen 7: 40-160mg formulation prototype selected from Part 1 (capsule or tablet) given without food;\n- Regimen 8: 40-160mg formulation prototype selected from Part 1 (capsule or tablet) given with food;\n- Regimen 9 (if dosed, optional): 40-160mg formulation prototype selected from Part 1 (capsule or tablet) given without food;\n- Regimen 10 (if dosed, optional): 40-160mg formulation prototype selected from Part 1 (capsule or tablet) given with food\n
REC name
Wales REC 2
REC reference
14/WA/1113
Date of REC Opinion
19 Sep 2014
REC opinion
Favourable Opinion