Phase 1 PK Study of OP-687 (QSC118215)
Research type
Research Study
Full title
A Phase 1 Study in 2 Parts Designed to Evaluate the Pharmacokinetics following Single-Dose Administration of Sustained Release OP-687 Prototype Formulations and a Sustained Release OP-687 Reference Formulation in Healthy Subjects in Part 1, and Single and Multiple-Dose Administration of a Selected Sustained Release OP-687 Prototype Formulation in Healthy Subjects in Part 2
IRAS ID
244220
Contact name
Miriam Adesokan
Contact email
Sponsor organisation
Outpost Medicine Ltd.
Eudract number
2018-001068-46
Duration of Study in the UK
0 years, 5 months, 12 days
Research summary
The Sponsor is developing the test medicine, OP-687, for the potential treatment of irritable bowel syndrome (a long-term disorder that affects the digestive system) and overactive bladder (where a person regularly gets a sudden need to pass urine). \n\nThe study consists of up to 2 Parts, involving up to 38 healthy male and female volunteers. \nPart 1 will investigate different recipes of the test medicine, OP-687, to find one which is absorbed slowly by the body and therefore only needs to be dosed once a day. Part 1 will also investigate if food affects how the test medicine is taken up by the body. Part 2 will look at the safety and tolerability of higher single and multiple doses of the test medicine.\n\nPart 1 will will involve up to 16 volunteers. 12 volunteers will attend the clinic for 4 days up to 7 times (periods) to receive Regimens A-G. Subjects will receive one dose of either the test medicine or reference formulation at each period. Subjects will arrive on Day-1, be dosed on Day 1 and be discharged on Day 3. Up to 4 replacement subjects may be dosed. \n\nPart 2 will enrol up to 22 subjects into 2 groups that will attend the clinical unit for 2 periods, to receive either the test medicine or placebo (dummy medicine). Subjects will be dosed on day 1, of Period 1 followed by a minimum 8 day break, then dosed daily from day 1 to day 5 of period 2. Up to 4 replacement subjects may be enrolled. \n\nA follow-up phone call will take place 5 to 7 days after the final dose of Part 1 and Part 2 to ensure the ongoing wellbeing of the subjects.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0636
Date of REC Opinion
29 Nov 2018
REC opinion
Further Information Favourable Opinion