A double-blind, randomised, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male volunteers
Part A - Single Ascending Dose (SAD) Double-blind, randomised, placebo-controlled, single ascending dose study. Each study subject will participate in a screen visit, three identical treatment periods, in each of which they will receive a single oral dose of V81444 or placebo in accord-ance with the randomisation schedule, and one post-study visit. In each treatment period, subjects will be admitted the day before dosing (Day -1) and, subject to satisfactory medical review, discharged in the morning, 4 days later (Day 4). Part B - Multiple Ascending Dose (MAD) Double-blind, randomised, placebo-controlled, parallel group, multiple ascending dose study Each study subject will participate in a screen visit, one treatment period in which they will receive repeated oral doses of V81444 or placebo in accordance with the randomisation schedule, and one post-study visit. In each treatment period, subjects will be admitted the day before dosing (Day -1), dosed daily on Days 1 to 14 and, subject to satisfactory medical review, will be discharged in the morning, 3 days after the final dose (Day 17).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
49
Single ascending oral doses of V81444 and placebo Multiple ascending oral doses of V81444 and placebo
Hammersmith Medicines Research
London, United Kingdom
Evaluate the safety of V81444 by assessing the frequency of adverse events
Time frame: From screening until 7 days post dosing
Evaluate the safety of V81444 by assessing laboratory safety assessments
Time frame: Lab safety assessments are taken at screening, day minus 1, 24h and 72h and post dosing
Evaluate the safety of V81444 by assessing ECG
Time frame: Taken at screening and until 7 days post dosing
Evaluate the safety of V81444 by assessing vital signs
Time frame: Taken at screening and until 7 days post dosing
Evaluate the safety of V81444 by assessing physical examination
Time frame: Taken at screening and post dosing
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