Oral Irritation Potential and Safety of MP0008
Research type
Research Study
Full title
An Open-Label, Multiple-Dose Study to Evaluate the Oral Tolerability of MP0008, an Orally Disintegrating Contraceptive Tablet, in Healthy Adult Female Subjects
IRAS ID
307298
Contact name
Herman Ellman
Contact email
Sponsor organisation
Millicent Pharma Limited
Eudract number
2021-005594-12
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
The purpose of this study is to evaluate the oral irritation potential of MP0008 oral disintegrating contraceptive tablet following daily use of one tablet over a 24-day treatment period in healthy adult female subjects.\n\nSince this formulation is an ODT, the soft tissue of the mouth will be exposed to the tablet and its active components for several minutes following dosing, for 24 days of the 28-day treatment cycle. Hence this study is designed to evaluate whether the exposure to this formulation is a potential cause of irritation to the soft tissues of the mouth.\n\nThis is a single-center, open-label, multiple-dose study sponsored by Millicent Pharma Limited.\n\nFifty-five (55), healthy, adult female subjects will be enrolled. Discontinued subjects will not be replaced.\n\nScreening period is up to 28 days.\n\nUpon successful completion of the screening procedures, eligible subjects who are not currently users of oral contraceptives will be asked to schedule a Baseline visit at the CRU on the first day (or within 2 days after the start) of their next menstrual flow. Oral contraceptive users will be asked to schedule the Baseline visit 5 (± 2) days (if they have been using a 24 day product) or 8 (±2) days (if they have been using a 21-day product), after their last scheduled dose of the active formulation of their usual product.\n\nOn Days 1 through 24, subjects will be instructed to take a QD dose of MP0008 ODT without water. Oral soft-tissue examination (mouth examination) will be performed at Baseline (if the screening examination is more than 24 hours before Day 1), 30 (±5) minutes postdose on Days 1, 3 (±1 day), and 10 (±2 days), and on Day 25 (±2 days).\n\nPrior to release from the CRU, subjects will receive a properly labeled container with the appropriate MP0008 doses which will be self administered by subjects out-of-CRU. Subjects will be instructed to self-administer the study drug approximately at the same time they received their first dose at the CRU (± 1 hour of dosing time on Day 1). Subjects will be given diaries to record the time of their self administered doses, whether the dose was accompanied or not by food or fluid, and any missed doses. Subjects must return the container/blister pack(s) (empty or not) and their diary at the next visit. Out of CRU dosing will be monitored via attempted phone calls, e-mails, or text messages where subjects will be reminded to take their medication and queried about the occurrence of AEs.\n\nFollow up visit will happen on Day 29 (±2 days).\n\nSafety will be monitored throughout the study by repeated clinical and laboratory evaluations.\n
REC name
HSC REC A
REC reference
21/NI/0174
Date of REC Opinion
22 Dec 2021
REC opinion
Further Information Favourable Opinion