Phase I, PK, Formulation and Food Effect Study (QSC201745)
Research type
Research Study
Full title
A Phase I, Open-Label Study to Evaluate the Pharmacokinetics, Relative Bioavailability, Effect of Food, Safety and Tolerability of Different NBI-74788 Prototype Formulations in Healthy Adult Subjects
IRAS ID
269122
Contact name
Litza McKenzie
Contact email
Sponsor organisation
Neurocrine Biosciences, Inc.
Eudract number
2019-002737-12
Duration of Study in the UK
Publication of this data is currently deferred.
Research summary
Neurocrine Biosciences (the sponsor) is developing a new test medicine called NBI-74788 to treat congenital adrenal hyperplasia (CAH). CAH is a rare disease. People with CAH are unable to make enough cortisol (a hormone) to support important functions in the body such as helping to control blood salt, water and sugar levels, blood pressure and the body’s response to stress. People with CAH often have higher levels of male steroid hormones, which can lead to early puberty and abnormal sexual development, particularly in females. Sometimes CAH can be life-threatening.\n\nThis study will assess how the body absorbs the new test medicine formulations (recipes) and compare this to a reference capsule formulation. It will also look at how the test medicine is taken up by the body with or without food, how the medicine tastes and the safety and tolerability of the test medicine. \n\nThe study will consist of a total of 4 treatment periods. Prior to study participation volunteers will have consented to participate in either 2 or 4 treatment periods. It is planned to enrol 36 volunteers into the first two periods. All subjects will receive a single dose of the current capsule form of the test medicine in one period and one of three new forms in the other period. The order in which they receive the new form or the current form will be allocated at random. After the second period, the results will be reviewed. Eighteen subjects will then continue into periods 3 and 4 and receive either a new formulation of the test medicine, a previously dosed formulation at a different dose or a previously dosed formulation in a different prandial state (fed or fasted or a different meal).\n
REC name
Wales REC 2
REC reference
19/WA/0230
Date of REC Opinion
28 Aug 2019
REC opinion
Further Information Favourable Opinion