Single and repeat doses of RVT-1201 in healthy subjects (QSC200305)
Research type
Research Study
Full title
Single and repeat dose study of RVT-1201 in healthy subjects to evaluate the pharmacokinetic profile of RVT-1201 and its active metabolite KAR5417
IRAS ID
240538
Contact name
Steve Piscitelli
Contact email
Sponsor organisation
Roivant Sciences Inc. on behalf of Roivant Sciences GmbH.
Eudract number
2017-005114-63
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
The sponsor is developing a new test medicine, RVT-1201, for the treatment of Pulmonary Arterial Hypertension (PAH). PAH is a severe, incurable disease caused by the walls of the arteries to the lungs becoming thick and stiff, narrowing the space for blood to pass through and raising blood pressure in the lungs. \n\nThe aim of this study is to develop a new oral formulation (recipe) of the test medicine which increases the maximum level of medicine reaching the blood in order to reduce the dose which needs to be given.\n\nThe study will consist of 2 parts, involving up to 58 healthy male and female volunteers. In Part 1, 10 volunteers will receive up to 4 single doses of the medicine, one dose each Period, with the fourth period being optional. Three different formulations of the medicine will be tested (Periods 1 to 3) and the impact of increasing the dose on a chosen formulation may then be investigated (Period 4). Each Period volunteers will be dosed following a standard breakfast and will remain on site for 48 hours for blood samples to be taken and safety assessments to be performed.\n\nPart 2 of the study is optional. Up to 48 volunteers may receive multiple doses of a selected formulation of the medicine or placebo (dummy medicine) chosen from data collected from Part 1. Volunteers will be split into groups of 12 and a different dose of a selected formulation will be tested in each group. Volunteers may receive either 1 or 2 doses of medicine or placebo each day for 14 days. Each group of volunteers will be dosed following a standard meal and will remain on site for 17 days for blood samples to be taken and safety assessments to be performed.
REC name
HSC REC A
REC reference
18/NI/0116
Date of REC Opinion
3 Jul 2018
REC opinion
Favourable Opinion