Safety and Pharmacokinetics of MT1988 in healthy adults
Research type
Research Study
Full title
A single centre, double blinded, randomised, parallel arm, placebo-controlled study to evaluate the safety and pharmacokinetics of MT1988 in healthy adults
IRAS ID
1009998
Contact name
Sheryl Caswell
Contact email
Sponsor organisation
Monument Therapeutics Ltd
ISRCTN Number
ISRCTN52183349
Clinicaltrials.gov Identifier
Research summary
This is a randomised, placebo controlled, multiple dose study in healthy volunteers.\n\nThe study will assess the effect of different doses of a new oral medication MT1988, developed to treat memory and concentration problems associated with schizophrenia.\n\nIn carrying out this study we will be looking at the safety and tolerability of different doses of MT1988 and levels of drugs absorbed into the blood.\nThe following treatments will be dosed during the study.\nTreatment A: 5mg Tropisetron, 1mg Varenicline\nTreatment B: 5mg Tropisetron, 2mg Varenicline\nTreatment C: 10mg Tropisetron, 2mg Varenicline\nTreatment D: 10mg Tropisetron, 3mg Varenicline\nTreatment E: Placebo\nEach dose of treatment will comprise of 2 capsules.\nBlood samples will be taken at screening, Day 1, 2, 7, 14, 15, 16 and 17 and early discontinuation/follow-up for safety biochemistry and haematology tests and will total approximately 85 mL. Samples will also be taken at each assessment visit to assess how much of the drug within the capsules are absorbed into the blood stream. The total blood volume taken throughout the study is approximately 223 mL. \n\nThere will be up to 38 healthy male and female adult volunteers enrolled across one study site. Eight participants will be randomised into each of the four dose cohorts and six will be randomised into the placebo cohort. \n\nParticipants will visit the site on 5 occasions excluding the visits during the screening period. The follow up assessment will be performed via telephone call although a face to face visit may be arranged at the discretion of the principal investigator or in the event of clinically significant abnormal safety assessments on day 14. \n\nThe first treatment administration will occur within 28 days of commencement of the screening period. Dosing will be once daily for 14 days. Doses on day 1, day 2, day 7 and day 14 will be administered on site . Participants will self-administer the remaining doses at home.
REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0703
Date of REC Opinion
6 Nov 2024
REC opinion
Further Information Favourable Opinion