A Trial to Evaluate Terguride in Subjects with CYP2D6 Genotypes.
Research type
Research Study
Full title
A Phase 1, Open-Label Trial to Evaluate the Effects of Single and Multiple Doses, CYP3A4 Inhibition and Food on the Pharmacokinetics of Terguride in Healthy Subjects with Known CYP2D6 Genotypes
IRAS ID
193124
Contact name
Brendan Colgan
Contact email
Sponsor organisation
Medac GmbH
Eudract number
2015-003729-33
ISRCTN Number
ISRCTN36145549
Duration of Study in the UK
0 years, 1 months, 18 days
Research summary
Systemic sclerosis (SSc, scleroderma) is a connective tissue disease of unknown etiology, which is highly heterogeneous in its multisystem clinical manifestations and follows a variable and unpredictable course. Pathophysiological features of SSc include fibrosis, autoimmunity, inflammation, and widespread vasculopathy, affecting multiple vascular beds. The involvement of organs such as kidney, lung, heart, and oesophageal tract are a cause of significant morbidity and mortality in SSc. \n\nTerguride is currently being developed as an oral treatment for diffuse cutaneous systemic sclerosis (dcSSc). \n\nNumerous nonclinical and clinical studies have been conducted to support development of terguride and submissions for marketing approval in various indications, and it has already been approved for the treatment of hyperprolactinemic pituitary adenoma, ovulation disorders due to hyperprolactinemia, galactorrhea and suppression of puerperal lactation.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/1987
Date of REC Opinion
4 Jan 2016
REC opinion
Further Information Favourable Opinion