DA-8010 - A SAD/MAD Study
Research type
Research Study
Full title
A Phase I, Randomised, Double Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects
IRAS ID
204236
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Dong-A ST Co., Ltd.
Eudract number
2016-001090-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 3 days
Research summary
\n“DA-8010 is an investigational medication which will be tested in humans for the first time. The drug is intended for use in people with overactive bladder (symptoms include an urgent feeling to go to the toilet, going to the toilet frequently and sometimes leaking urine before you can get to the toilet) \n\nThis will be a double blind, placebo controlled study meaning some volunteers will be given the Study Drug, and some volunteers will be given a “dummy” drug. Neither the volunteer, nor the investigator will know who received the Drug or placebo.\n\nPart A\nIn Part A, volunteers will receive check-in to the unit the day before dosing for eligibility checks. All being well, the volunteer will be given a single dose the following morning and have various safety assessments performed and blood samples taken. The volunteer will remain in the unit a further 2 days after dosing before being discharged from the unit. \n\nIn Group A4, volunteers will participate in two treatment periods separated by about 2 weeks to measure the effect of food on the Study Drug. Dosing on the first occasion will be in a fasted state and dosing on the second occasion will be after eating a breakfast before dosing.\n\nPart B\nIn Part B, volunteers will check-in to the unit the day before dosing for eligibility checks. All being well, the volunteer will be given daily doses (this could be once or twice per day) the following day and for a further 6 days (this could be reduced or increased depending on results from Part A of the study). Volunteers will be discharged from the unit 2 days after their final dose.\n\nAfter the first group, all the dose levels for following groups will be decided based on review of the data collected from the previous group(s).\n\nIn both parts, all volunteers will return for a post-study visit 5 to 7 days after their final dose.”\n
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0139
Date of REC Opinion
2 Jun 2016
REC opinion
Further Information Favourable Opinion