Participant characteristics
In the PK study 8 participants were randomized to
both QD–BID and BID–QD dosing.
In the QD–BID cohort mean (SD) age was higher than the BID–QD cohort
(35.6 [7.8] years vs 28.0 [10.1] years) and there were fewer
female participants (25% vs 50%), while mean (SD) BMI was comparable
across the two groups (25.0 [2.5] kg/m2 vs 24.7
[3.2] kg/m2). All participants completed the
assigned study treatment.
Of 28 individuals enrolled in the PET study, 7 received a single dose of
MR309 and completed the study (Cohort 1: 400 mg n=2, Cohort 2: 200 mg
n=2, Cohort 3: 800 mg n=2, Cohort 4: 200 mg n=1; selection of doses for
Cohorts 2, 3 and 4 were based binding data associated with the prior
dose). One additional subject underwent a baseline PET scan only, and
their participation in the study was terminated prior to treatment with
MR309 due to a positive drug test. All the participants who received
MR309 were male, median (range) age was 49 (26–59) years and median
(range) BMI was 24.4 (22.7, 29.9) kg/m2.