This will be a Phase 1, single-center, 2-part study in healthy subjects. Parts 1 and 2 need to be conducted in sequential order.
Part 1 will enroll up to 3 cohorts of 6 healthy adult subjects to receive a single dose. The total duration of participation from the Screening visit to the follow-up will be up to 7 weeks (up to 45 days). Part 2 of this study will randomize approximately 32 subjects. The total duration of participation from the Screening visit to the follow-up will be up to 8 weeks (up to 55 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6
Participants will receive a single dose of placebo on Day 1, Day 8 or Day 15 of part 2
Participants will receive a single dose of moxifloxacin on Day 1,Day 8, or Day 15 of Part 2
Participants will receive a single dose of Milademetan on Day 1 for part 1 Participants will receive a single dose of milademetan on Day 1, Day 8, or Day 15 of Part 2
Nucleus Network Melbourne
Melbourne, Victoria, Australia
Number of participants with adverse events (AEs)
The intensity of all AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Part 1:Up to 15 days
Number of participants with adverse events (AEs)
The intensity of all AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Part 2: Up to 25 days
Incidence of laboratory abnormalities based on hematology test results
Hematocrit, Hemoglobin, Mean cell hemoglobin
Time frame: Part 1:Up to 15 days
Incidence of laboratory abnormalities based on hematology test results
Hematocrit, Hemoglobin, Mean cell hemoglobin
Time frame: Part 2: Up to 25 days
Incidence of laboratory abnormalities based on clinical chemistry test results
Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase
Time frame: Part 1:Up to 15 days
Incidence of laboratory abnormalities based on clinical chemistry test results
Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase
Time frame: Part 2: Up to 25 days
Incidence of laboratory abnormalities based on urinalysis test results
Bilirubin, color and appearance, glucose, ketones, protein
Time frame: Part 1:Up to 15 days
Incidence of laboratory abnormalities based on urinalysis test results
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Bilirubin, color and appearance, glucose, ketones, protein
Time frame: Part 2: Up to 25 days
Vital signs measurements
Supine systolic blood pressure in mmHg and supine diastolic blood pressure in mmHg
Time frame: Part 1:Up to 15 days
Vital signs measurements
Supine systolic blood pressure in mmHg and supine diastolic blood pressure in mmHg
Time frame: Part 2: Up to 25 days
Change from baseline in QT interval of the ECG
QT interval measured in msec
Time frame: Part 1:Up to 15 days
Change from baseline in QT interval of the ECG
QT interval measured in msec
Time frame: Part 2: Up to 25 days
Observed maximum plasma concentration (Cmax)
observed maximum plasma concentration in ng/ml
Time frame: Part 1:Up to 15 days
Observed maximum plasma concentration (Cmax)
observed maximum plasma concentration in ng/ml
Time frame: Part 2: Up to 25 days
Time to observed maximum concentration (Tmax)
time to observed maximum concentration in hour
Time frame: Part 1:Up to 15 days
Time to observed maximum concentration (Tmax)
time to observed maximum concentration in hour
Time frame: Part 2: Up to 25 days
area under the time-concentration curve from time zero to the time of the last quantifiable concentration (AUC0-tlast)
Expressed as ng/ml x hr
Time frame: Part 1:Up to 15 days
area under the time-concentration curve from time zero to the time of the last quantifiable concentration (AUC0-tlast)
Expressed as ng/ml x hr
Time frame: Part 2: Up to 25 days