Trial Outcomes & Findings for MLN3126 Single Rising Dose Study (NCT NCT02447458)
NCT ID: NCT02447458
Last Updated: 2015-08-05
Results Overview
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Up to Day 22
Results posted on
2015-08-05
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 19 August 2013 (first participant signed informed consent form) to 05 February 2014.
Healthy volunteers were enrolled in 1 of 5 MLN3126 ascending dose treatment groups: once a day 300 mg, 600 mg, 1000 mg under fed or fasting conditions,1500 mg or 2000 mg OR once a day placebo.
Participant milestones
| Measure |
MLN3126 300 mg
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
COMPLETED
|
5
|
6
|
5
|
6
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MLN3126 300 mg
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
MLN3126 Single Rising Dose Study
Baseline characteristics by cohort
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=10 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.8 Years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
30.3 Years
STANDARD_DEVIATION 6.50 • n=7 Participants
|
41.2 Years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
32.3 Years
STANDARD_DEVIATION 11.78 • n=4 Participants
|
30.0 Years
STANDARD_DEVIATION 8.39 • n=21 Participants
|
32.8 Years
STANDARD_DEVIATION 6.32 • n=10 Participants
|
33.7 Years
STANDARD_DEVIATION 9.10 • n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
7 participants
n=10 Participants
|
28 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=10 Participants
|
10 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=10 Participants
|
10 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
7 participants
n=10 Participants
|
29 participants
n=115 Participants
|
|
Height
|
170.8 cm
STANDARD_DEVIATION 10.64 • n=5 Participants
|
172.3 cm
STANDARD_DEVIATION 5.47 • n=7 Participants
|
174.7 cm
STANDARD_DEVIATION 10.42 • n=5 Participants
|
169.8 cm
STANDARD_DEVIATION 5.71 • n=4 Participants
|
173.3 cm
STANDARD_DEVIATION 6.09 • n=21 Participants
|
174.9 cm
STANDARD_DEVIATION 13.08 • n=10 Participants
|
172.9 cm
STANDARD_DEVIATION 9.14 • n=115 Participants
|
|
Weight
|
78.00 kg
STANDARD_DEVIATION 12.900 • n=5 Participants
|
81.98 kg
STANDARD_DEVIATION 8.538 • n=7 Participants
|
83.67 kg
STANDARD_DEVIATION 15.871 • n=5 Participants
|
72.22 kg
STANDARD_DEVIATION 7.165 • n=4 Participants
|
75.87 kg
STANDARD_DEVIATION 10.016 • n=21 Participants
|
82.58 kg
STANDARD_DEVIATION 7.420 • n=10 Participants
|
79.44 kg
STANDARD_DEVIATION 10.498 • n=115 Participants
|
|
Body Mass Index (BMI)
|
26.65 kg/m^2
STANDARD_DEVIATION 2.643 • n=5 Participants
|
27.56 kg/m^2
STANDARD_DEVIATION 2.127 • n=7 Participants
|
27.18 kg/m^2
STANDARD_DEVIATION 2.293 • n=5 Participants
|
25.01 kg/m^2
STANDARD_DEVIATION 1.811 • n=4 Participants
|
25.16 kg/m^2
STANDARD_DEVIATION 2.329 • n=21 Participants
|
27.22 kg/m^2
STANDARD_DEVIATION 3.251 • n=10 Participants
|
26.54 kg/m^2
STANDARD_DEVIATION 2.587 • n=115 Participants
|
|
Caffeine Consumption
Yes
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
10 participants
n=115 Participants
|
|
Caffeine Consumption
No
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
7 participants
n=10 Participants
|
29 participants
n=115 Participants
|
|
Smoking Classification
Never smoked
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
10 participants
n=10 Participants
|
37 participants
n=115 Participants
|
|
Smoking Classification
Current smoker
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
|
Smoking Classification
Ex-smoker
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to Day 22Population: Safety population included all enrolled participants who received at least 1 dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=10 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
n=5 Participants
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
n=2 Participants
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants That Experience At Least One Treatment-Emergent Adverse Event (TEAE) Post-Dose
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 16Population: Safety population included all enrolled participants who received at least 1 dose of study drug.
Clinical safety laboratory tests included clinical chemistry, hematology and urinalysis. The percentage of participants with any markedly abnormal laboratory finding during the study.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=10 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
n=5 Participants
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
n=2 Participants
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Clinical Laboratory Results Post-Dose
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 16Population: Safety population included all enrolled participants who received at least 1 dose of study drug.
Vital signs included oral body temperature measurement, blood pressure, respiration rate, and pulse rate \[beats per minute (bpm) or heart rate\]. The percentage of participant with markedly abnormal vital signs findings during the study. OBP=Orthostatic Blood Pressure. All OBP measurements were standing.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=10 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
n=5 Participants
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
n=2 Participants
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Pulse - supine
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
16.7 Percentage of Participants
|
33.3 Percentage of Participants
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Pulse - standing 1 minute
|
40.0 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
16.7 Percentage of Participants
|
20.0 Percentage of Participants
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Pulse - standing 3 minutes
|
20.0 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
10.0 Percentage of Participants
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Systolic Blood pressure (BP) - supine
|
20.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Systolic Blood pressure - standing 1 minute
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
20.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Systolic Blood pressure - standing 3 minutes
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
20.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Diastolic blood pressure - supine
|
40.0 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
16.7 Percentage of Participants
|
20.0 Percentage of Participants
|
20.0 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Diastolic blood pressure - standing 1 minute
|
20.0 Percentage of Participants
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
30.0 Percentage of Participants
|
40.0 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Diastolic blood pressure - standing 3 minutes
|
20.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
20.0 Percentage of Participants
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
OBP systolic - 1 minutes (Decrease of >40 mmHg)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
OBP systolic - 3 minutes (Decrease of >40 mmHg)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
OBP diastolic - 1 minutes (Decrease >20 mmHg)
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
33.3 Percentage of Participants
|
40.0 Percentage of Participants
|
20.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
OBP diastolic - 3 minutes (Decrease >20 mmHg)
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
33.3 Percentage of Participants
|
50.0 Percentage of Participants
|
33.3 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
50.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 16Population: Safety population included all enrolled participants who received at least 1 dose of study drug.
A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=10 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
n=5 Participants
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
n=2 Participants
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose
Heart Rate
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
33.3 Percentage of Participants
|
20.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose
PR Interval
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
10.0 Percentage of Participants
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose
QRS Interval
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
10.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose
QTc - Fredericia's
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose
QTc Interval
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)Population: Pharmacokinetic (PK) analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=5 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Plasma Concentration of MLN3126 and Metabolite M-I
MLN3126
|
2466.00 ng/mL
Standard Deviation 387.208
|
3605.00 ng/mL
Standard Deviation 920.885
|
4061.67 ng/mL
Standard Deviation 1192.299
|
5490.00 ng/mL
Standard Deviation 1110.531
|
8200.00 ng/mL
Standard Deviation 1937.431
|
9444.00 ng/mL
Standard Deviation 1929.632
|
—
|
—
|
|
Cmax: Maximum Plasma Concentration of MLN3126 and Metabolite M-I
MLN3126 M-I Metabolite
|
125.26 ng/mL
Standard Deviation 44.940
|
238.17 ng/mL
Standard Deviation 101.275
|
278.17 ng/mL
Standard Deviation 176.552
|
374.00 ng/mL
Standard Deviation 78.908
|
424.83 ng/mL
Standard Deviation 131.574
|
684.40 ng/mL
Standard Deviation 556.234
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)Population: PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.
Tmax is the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=5 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Maximum Plasma Concentration of MLN3126 and Metabolite M-I
MLN3126
|
2.00 Hours
Full Range 1.884 • Interval 1.5 to 6.0
|
3.00 Hours
Full Range 0.894 • Interval 2.0 to 4.0
|
3.14 Hours
Full Range 0.902 • Interval 2.0 to 4.0
|
2.50 Hours
Full Range 2.345 • Interval 2.0 to 8.0
|
3.01 Hours
Full Range 0.752 • Interval 2.0 to 4.0
|
6.00 Hours
Interval 4.0 to 10.0
|
—
|
—
|
|
Tmax: Time to Maximum Plasma Concentration of MLN3126 and Metabolite M-I
MLN3126 M-I Metabolite
|
4.00 Hours
Interval 4.0 to 6.0
|
4.00 Hours
Interval 4.0 to 8.0
|
4.00 Hours
Interval 4.0 to 8.0
|
4.00 Hours
Interval 4.0 to 10.0
|
4.00 Hours
Interval 4.0 to 8.0
|
8.00 Hours
Interval 6.0 to 10.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)Population: PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=5 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
AUC(0-tlqc): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to the Last Quantifiable Concentration
MLN3126
|
41480.14 ng*hr/mL
Standard Deviation 7541.025
|
63117.71 ng*hr/mL
Standard Deviation 26292.596
|
73474.61 ng*hr/mL
Standard Deviation 29655.501
|
108475.58 ng*hr/mL
Standard Deviation 20425.152
|
133029.91 ng*hr/mL
Standard Deviation 44849.002
|
248462.35 ng*hr/mL
Standard Deviation 72106.157
|
—
|
—
|
|
AUC(0-tlqc): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to the Last Quantifiable Concentration
MLN3126 M-I Metabolite
|
1961.73 ng*hr/mL
Standard Deviation 1106.451
|
4096.06 ng*hr/mL
Standard Deviation 2261.405
|
5550.19 ng*hr/mL
Standard Deviation 5139.476
|
6724.92 ng*hr/mL
Standard Deviation 2067.765
|
6110.64 ng*hr/mL
Standard Deviation 1936.969
|
11989.43 ng*hr/mL
Standard Deviation 10546.217
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)Population: PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.
AUC(0-inf) is measure of area under the curve from time 0 to infinity.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=5 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
AUC(0-inf): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to Infinity
MLN3126
|
41765.17 ng*hr/mL
Standard Deviation 7549.827
|
63508.18 ng*hr/mL
Standard Deviation 26520.426
|
78964.45 ng*hr/mL
Standard Deviation 40182.582
|
110437.12 ng*hr/mL
Standard Deviation 20911.078
|
134119.22 ng*hr/mL
Standard Deviation 45470.528
|
250789.67 ng*hr/mL
Standard Deviation 73569.482
|
—
|
—
|
|
AUC(0-inf): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to Infinity
MLN3126 M-I Metabolite
|
1993.65 ng*hr/mL
Standard Deviation 1099.291
|
4132.89 ng*hr/mL
Standard Deviation 2266.377
|
6668.14 ng*hr/mL
Standard Deviation 7725.447
|
6949.52 ng*hr/mL
Standard Deviation 2129.918
|
6177.45 ng*hr/mL
Standard Deviation 1977.067
|
12068.75 ng*hr/mL
Standard Deviation 10609.268
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)Population: PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.
CL/F is apparent clearance of the drug from the plasma, after extravascular administration.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=5 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
CL/F: Oral Clearance of MLN3126
|
7.39 L/hr
Standard Deviation 1.457
|
11.34 L/hr
Standard Deviation 5.934
|
15.12 L/hr
Standard Deviation 6.345
|
13.97 L/hr
Standard Deviation 2.473
|
16.76 L/hr
Standard Deviation 6.656
|
4.23 L/hr
Standard Deviation 1.066
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)Population: PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=5 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
T ½: Half-life of MLN3126 and Metabolite M-I
MLN3126
|
13.94 Hours
Standard Deviation 0.992
|
12.80 Hours
Standard Deviation 0.624
|
16.07 Hours
Standard Deviation 5.899
|
16.31 Hours
Standard Deviation 3.706
|
13.63 Hours
Standard Deviation 1.888
|
13.92 Hours
Standard Deviation 0.894
|
—
|
—
|
|
T ½: Half-life of MLN3126 and Metabolite M-I
MLN3126 M-I Metabolite
|
13.44 Hours
Standard Deviation 1.815
|
13.47 Hours
Standard Deviation 1.524
|
19.88 Hours
Standard Deviation 16.767
|
20.89 Hours
Standard Deviation 9.006
|
14.09 Hours
Standard Deviation 3.053
|
13.56 Hours
Standard Deviation 1.960
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)Population: PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.
Ae (0-96) is the total amount of drug excreted in urine from time 0 to time 96 hours.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=5 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Ae (0-96): Total Amount of MLN3126 and Metabolite M-I Excreted in the Urine
MLN3126
|
65864.50 ng
Standard Deviation 13803.378
|
128194.87 ng
Standard Deviation 41264.086
|
115101.67 ng
Standard Deviation 101342.371
|
115443.11 ng
Standard Deviation 45489.137
|
179199.95 ng
Standard Deviation 94480.203
|
216883.09 ng
Standard Deviation 193535.668
|
—
|
—
|
|
Ae (0-96): Total Amount of MLN3126 and Metabolite M-I Excreted in the Urine
MLN3126 M-I Metabolite
|
1606271.00 ng
Standard Deviation 661316.505
|
3785848.92 ng
Standard Deviation 1487530.534
|
3669719.92 ng
Standard Deviation 3805989.870
|
3042712.33 ng
Standard Deviation 1087430.529
|
4934093.92 ng
Standard Deviation 2367261.267
|
7969436.83 ng
Standard Deviation 9141564.346
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)Population: PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.
Fe is the Fraction of drug excreted in urine, calculated as Fe=(Ae\[0-t\]/dose)×100.
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=5 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Fe: Fraction of MLN3126 Excreted in the Urine
|
0.02 Percentage
Standard Deviation 0.005
|
0.02 Percentage
Standard Deviation 0.007
|
0.01 Percentage
Standard Deviation 0.002
|
0.01 Percentage
Standard Deviation 0.003
|
0.01 Percentage
Standard Deviation 0.005
|
0.01 Percentage
Standard Deviation 0.007
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)Population: PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.
Renal clearance was calculated as CLr=Ae(0-96)/AUC (0-96).
Outcome measures
| Measure |
MLN3126 300 mg
n=5 Participants
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 Participants
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=5 Participants
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 Participants
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 Participants
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=4 Participants
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr) of MLN3126 and Metabolite M-I
MLN3126
|
0.03 mL/min
Standard Deviation 0.010
|
0.04 mL/min
Standard Deviation 0.010
|
0.02 mL/min
Standard Deviation 0.010
|
0.02 mL/min
Standard Deviation 0.010
|
0.02 mL/min
Standard Deviation 0.012
|
0.01 mL/min
Standard Deviation 0.004
|
—
|
—
|
|
Renal Clearance (CLr) of MLN3126 and Metabolite M-I
MLN3126 M-I Metabolite
|
16.00 mL/min
Standard Deviation 9.945
|
16.15 mL/min
Standard Deviation 3.426
|
10.34 mL/min
Standard Deviation 7.285
|
7.89 mL/min
Standard Deviation 2.544
|
13.69 mL/min
Standard Deviation 7.728
|
9.05 mL/min
Standard Deviation 5.598
|
—
|
—
|
Adverse Events
MLN3126 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MLN3126 600 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MLN3126 1000 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MLN3126 1500 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MLN3126 2000 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MLN3126 1000 mg (Fed)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (Fed)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MLN3126 300 mg
n=5 participants at risk
MLN3126 300 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 600 mg
n=6 participants at risk
MLN3126 600 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg
n=6 participants at risk
MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
MLN3126 1500 mg
n=6 participants at risk
MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
|
MLN3126 2000 mg
n=6 participants at risk
MLN3126 2000 mg tablets, orally, fasting once on Day 1.
|
Placebo
n=10 participants at risk
Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
|
MLN3126 1000 mg (Fed)
n=5 participants at risk
MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
Placebo (Fed)
n=2 participants at risk
Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
20.0%
1/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
0.00%
0/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study drug to 30 days post last dose (Up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER