SAD and MAD study to assess the PK of MR311 in healthy volunteers
Research type
Research Study
Full title
An open label, 7-cohort, single and multiple dose study to assess the pharmacokinetics of MR311 in healthy volunteers.
IRAS ID
233899
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Mundipharma Research Limited
Eudract number
2017-002847-14
Duration of Study in the UK
0 years, 4 months, 23 days
Research summary
MR311 is a currently licensed drug for the treatment of emergency relief of moderate and severe pain in patients with trauma and associated pain. Currently little is known about the levels of parent and metabolite in plasma following inhaled administration of MR311. \nThis is an open-label, study in healthy volunteers to assess the safety, tolerability of MR311 over a variety of single and multiple doses as well as to investigate how MR311 and its metabolites are processed by the body via analyzing concentrations in the blood.\nUp to 56 healthy male subjects, aged 18-45 years will be included in this trial. There will be 7 cohorts of up to 8 subjects each with all subjects receiving MR311. Volunteers will inhale MR311 via a handheld device containing liquid MR311. The starting dose for Cohort 1 will be 5 consecutive inhalations taken from an inhaler loaded with 3mL of MR311. Doses will be escalated for each new cohort with subjects in Cohorts 6 and 7 being given an inhaler loaded with 3mL of MR311 and being asked to self-administer over an hour. Cohort 7 would receive this dose twice (i.e. a multiple dose) once on Day 1 and Day 3. Safety data review meetings will be conducted between each cohort to review subject safety and all available blood level data. \nVolunteers in Cohorts 1-6 will be screened to confirm eligibility and then admitted to the study unit on Day -1, dosed on Day 1 and discharged 3 days after receiving their dose. All volunteers will attend the unit for a medical review between Days 14-17 after their last study dose.\n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0465
Date of REC Opinion
13 Oct 2017
REC opinion
Favourable Opinion