Formulation Study of Dichlorphenamide in Healthy Subjects (QCL118244)
Research type
Research Study
Full title
A Phase 1, Open-Label Study Designed to Evaluate the Pharmacokinetic Profile of Dichlorphenamide Following Single-Dose and Multiple-Dose Administration of Modified Release Prototype Formulations and an Immediate Release Reference Formulation in Healthy Subjects
IRAS ID
242023
Contact name
Fred Cohen
Contact email
Sponsor organisation
Strongbridge U.S. Inc.
Eudract number
2018-002268-18
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
The Sponsor, Strongbridge U.S. Inc., is developing different formulations (recipes) of the test medicine dichlorphenamide as a tablet to be taken by mouth. Dichlorphenamide is already marketed in the US (as Keveyis®) as an immediate release tablet, taken twice a day, used for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis and related variants, which are occasional episodes of muscle weakness or paralysis (loss of movement) caused by higher or lower than normal levels of potassium in a patient’s blood.\n\nThe purpose of this study is to help develop a new modified release tablet formulation (recipe) of the test medicine with an improved safety profile (less side effects) that can be taken once a day. The study will consist of up to 2 parts. In Part 1, the study will look at how different modified release tablet formulations are taken up by the body when given once a day, compared to the marketed formulation. In Part 2 (optional), the study will assess how multiple doses of the selected formulation are taken up by the body and use the Qmci inventory for the detection of volunteer cognitive changes following dosing with dichlorphenamide.\n\nIn Part 1, 16 healthy male and female volunteers will receive 5 single doses of up to 200 mg dichlorphenamide. Once dosed, volunteers will stay in the clinical unit for 48 h for blood samples to be taken and safety assessments performed. \n\nIn Part 2 (optional), up to 16 healthy male and female volunteers will receive daily doses of up to 200 mg dichlorphenamide a day for 15 days. Volunteers will stay in the clinical unit for 18 days (48 h after their final dose) for blood samples to be taken and safety assessments performed. \n\n
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0290
Date of REC Opinion
25 Jun 2019
REC opinion
Favourable Opinion