Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants (NCT NCT02209506)
NCT ID: NCT02209506
Last Updated: 2016-07-25
Results Overview
A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Baseline up to 7 days after last dose of study drug (Day 22)
Results posted on
2016-07-25
Participant Flow
Participants took part in the study at single site in the United States from 04 August 2014 to 09 December 2014.
Part A was performed on non-Japanese participants and Part B was performed on Japanese participants. Planned doses of MLN3126 800 mg to be decided (TBD) dose for Part A, and MLN3126 300 mg, 800 mg, and TBD dose for Part 2 were not administered due to early termination of the study.
Participant milestones
| Measure |
Part A: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
6
|
2
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
6
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part A: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=3 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
n=2 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 7.77 • n=93 Participants
|
38.8 years
STANDARD_DEVIATION 12.91 • n=4 Participants
|
36.3 years
STANDARD_DEVIATION 7.12 • n=27 Participants
|
52.5 years
STANDARD_DEVIATION 0.71 • n=483 Participants
|
41.0 years
STANDARD_DEVIATION 12.47 • n=36 Participants
|
39.7 years
STANDARD_DEVIATION 10.50 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
15 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
6 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic or Latino
|
2 participants
n=93 Participants
|
5 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
6 participants
n=36 Participants
|
17 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
1 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
6 participants
n=36 Participants
|
9 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
2 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
7 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
6 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
6 participants
n=27 Participants
|
2 participants
n=483 Participants
|
6 participants
n=36 Participants
|
23 participants
n=10 Participants
|
|
Height
|
173.3 centimeter
STANDARD_DEVIATION 4.93 • n=93 Participants
|
173.0 centimeter
STANDARD_DEVIATION 14.71 • n=4 Participants
|
170.3 centimeter
STANDARD_DEVIATION 10.84 • n=27 Participants
|
170.0 centimeter
STANDARD_DEVIATION 5.66 • n=483 Participants
|
163.2 centimeter
STANDARD_DEVIATION 9.33 • n=36 Participants
|
169.5 centimeter
STANDARD_DEVIATION 10.76 • n=10 Participants
|
|
Weight
|
81.70 kilogram
STANDARD_DEVIATION 13.023 • n=93 Participants
|
82.50 kilogram
STANDARD_DEVIATION 15.920 • n=4 Participants
|
79.50 kilogram
STANDARD_DEVIATION 13.435 • n=27 Participants
|
74.45 kilogram
STANDARD_DEVIATION 3.323 • n=483 Participants
|
64.15 kilogram
STANDARD_DEVIATION 10.227 • n=36 Participants
|
76.12 kilogram
STANDARD_DEVIATION 14.004 • n=10 Participants
|
|
Body Mass Index
|
27.13 kilogram per square meter
STANDARD_DEVIATION 3.616 • n=93 Participants
|
27.36 kilogram per square meter
STANDARD_DEVIATION 2.080 • n=4 Participants
|
27.25 kilogram per square meter
STANDARD_DEVIATION 2.547 • n=27 Participants
|
25.77 kilogram per square meter
STANDARD_DEVIATION 0.564 • n=483 Participants
|
23.94 kilogram per square meter
STANDARD_DEVIATION 1.559 • n=36 Participants
|
26.27 kilogram per square meter
STANDARD_DEVIATION 2.531 • n=10 Participants
|
|
Smoking Classification
Never Smoked
|
2 participants
n=93 Participants
|
5 participants
n=4 Participants
|
4 participants
n=27 Participants
|
1 participants
n=483 Participants
|
4 participants
n=36 Participants
|
16 participants
n=10 Participants
|
|
Smoking Classification
Ex-Smoker
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
1 participants
n=483 Participants
|
2 participants
n=36 Participants
|
7 participants
n=10 Participants
|
|
Xanthine/Caffeine History
Consumer
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
4 participants
n=36 Participants
|
7 participants
n=10 Participants
|
|
Xanthine/Caffeine History
Non-Consumer
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
6 participants
n=27 Participants
|
1 participants
n=483 Participants
|
2 participants
n=36 Participants
|
16 participants
n=10 Participants
|
|
Female Reproductive Status
Postmenopausal
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
1 participants
n=10 Participants
|
|
Female Reproductive Status
Surgically Sterile
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
1 participants
n=10 Participants
|
|
Female Reproductive Status
Female of Childbearing Potential
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
6 participants
n=10 Participants
|
|
Alcohol Classification
Never Drunk
|
1 participants
n=93 Participants
|
4 participants
n=4 Participants
|
2 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
7 participants
n=10 Participants
|
|
Alcohol Classification
Current Drinker
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
2 participants
n=483 Participants
|
6 participants
n=36 Participants
|
14 participants
n=10 Participants
|
|
Alcohol Classification
Ex-Drinker
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
2 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 7 days after last dose of study drug (Day 22)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Part A: Placebo
n=3 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
n=2 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline up to 7 days after last dose of study drug (Day 22)Population: Safety analysis set included all 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 |
Part A: Placebo
n=3 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
n=2 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Electrocardiogram Measurements at Least Once Post Dose
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 7 days after last dose of study drug (Day 22)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
The percentage of participants with any markedly abnormal, according to Takeda criteria, standard safety laboratory values, including hematology, serum chemistry, and urinalysis, during the treatment period.
Outcome measures
| Measure |
Part A: Placebo
n=3 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
n=2 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 7 days after last dose of study drug (Day 22)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
The percentage of participants who meet markedly abnormal criteria designated by Takeda Global Research and Development Center, Inc. (TGRD). Criteria for markedly abnormal vital signs included body temperature, systolic blood pressure, diastolic blood pressure and pulse rate.
Outcome measures
| Measure |
Part A: Placebo
n=3 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
n=2 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
|
3 percentage of participants
|
2 percentage of participants
|
6 percentage of participants
|
0 percentage of participants
|
8 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The pharmacokinetic (PK) analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite
Day 1 (MLN3126) (n=6, 6, 6)
|
2053.33 nanogram per milliliter (ng/mL)
Standard Deviation 420.983
|
3220.00 nanogram per milliliter (ng/mL)
Standard Deviation 730.479
|
2526.67 nanogram per milliliter (ng/mL)
Standard Deviation 702.244
|
—
|
—
|
|
Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite
Day 15 (MLN3126) (n=6, 6, 5)
|
1845.00 nanogram per milliliter (ng/mL)
Standard Deviation 617.665
|
3088.33 nanogram per milliliter (ng/mL)
Standard Deviation 721.565
|
2200.00 nanogram per milliliter (ng/mL)
Standard Deviation 541.618
|
—
|
—
|
|
Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite
Day 1 (M-I) (n=6, 6, 6)
|
167.00 nanogram per milliliter (ng/mL)
Standard Deviation 73.645
|
225.77 nanogram per milliliter (ng/mL)
Standard Deviation 74.661
|
157.60 nanogram per milliliter (ng/mL)
Standard Deviation 83.847
|
—
|
—
|
|
Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite
Day 15 (M-I) (n=6, 6, 5)
|
149.57 nanogram per milliliter (ng/mL)
Standard Deviation 79.078
|
176.58 nanogram per milliliter (ng/mL)
Standard Deviation 55.561
|
149.12 nanogram per milliliter (ng/mL)
Standard Deviation 80.138
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite
Day 1 (MLN3126) (n=6, 6, 6)
|
4.00 hours
Interval 2.0 to 4.0
|
4.00 hours
Interval 4.0 to 4.0
|
4.00 hours
Interval 4.0 to 4.0
|
—
|
—
|
|
Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite
Day 15 (MLN3126) (n=6, 6, 5)
|
4.00 hours
Interval 2.0 to 4.0
|
4.00 hours
Interval 2.0 to 4.0
|
4.00 hours
Interval 4.0 to 4.0
|
—
|
—
|
|
Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite
Day 1 (M-I) (n=6, 6, 6)
|
5.00 hours
Interval 4.0 to 8.0
|
6.00 hours
Interval 4.0 to 8.0
|
6.00 hours
Interval 4.0 to 6.0
|
—
|
—
|
|
Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite
Day 15 (M-I) (n=6, 6, 5)
|
6.00 hours
Interval 4.0 to 6.0
|
4.00 hours
Interval 4.0 to 4.0
|
4.00 hours
Interval 4.0 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite
Day 15 (MLN3126) (n=6, 6, 5)
|
15748.80 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 3632.489
|
26353.06 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 5626.212
|
18166.90 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 4516.041
|
—
|
—
|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite
Day 1 (MLN3126) (n=6, 6, 6)
|
21429.42 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 3241.902
|
41451.93 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 10339.782
|
27344.25 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 6318.106
|
—
|
—
|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite
Day 1 (M-I) (n=6, 6, 6)
|
2027.06 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 1038.274
|
2935.78 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 1180.471
|
1721.86 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 768.842
|
—
|
—
|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite
Day 15 (M-I) (n=6, 6, 5)
|
1698.10 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 857.178
|
1920.06 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 689.354
|
1634.08 nanogram*hour per milliliter (ng*hr/mL
Standard Deviation 849.800
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite
Day 1 (MLN3126) (n=6, 6, 6)
|
28827.86 ng*hr/mL
Standard Deviation 4652.165
|
55970.97 ng*hr/mL
Standard Deviation 14936.883
|
35900.38 ng*hr/mL
Standard Deviation 8806.878
|
—
|
—
|
|
AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite
Day 15 (MLN3126) (n=6, 6, 5)
|
19240.50 ng*hr/mL
Standard Deviation 4032.308
|
33136.84 ng*hr/mL
Standard Deviation 7352.192
|
22929.63 ng*hr/mL
Standard Deviation 6521.723
|
—
|
—
|
|
AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite
Day 1 (M-I) (n=6, 6, 6)
|
2467.13 ng*hr/mL
Standard Deviation 1308.583
|
3713.57 ng*hr/mL
Standard Deviation 1628.713
|
2025.77 ng*hr/mL
Standard Deviation 888.467
|
—
|
—
|
|
AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite
Day 15 (M-I) (n=6, 6, 5)
|
2017.37 ng*hr/mL
Standard Deviation 989.383
|
2392.01 ng*hr/mL
Standard Deviation 930.338
|
1989.59 ng*hr/mL
Standard Deviation 1005.862
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite
Day 1 (MLN3126) (n=6, 6, 6)
|
28827.86 ng*hr/mL
Standard Deviation 4652.165
|
55971.02 ng*hr/mL
Standard Deviation 14936.843
|
35900.38 ng*hr/mL
Standard Deviation 8806.878
|
—
|
—
|
|
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite
Day 15 (MLN3126) ((n=6, 6, 5)
|
19240.50 ng*hr/mL
Standard Deviation 4032.308
|
33136.80 ng*hr/mL
Standard Deviation 7352.169
|
22929.63 ng*hr/mL
Standard Deviation 6521.723
|
—
|
—
|
|
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite
Day 1 (M-I) (n=6, 6, 6)
|
2478.39 ng*hr/mL
Standard Deviation 1296.387
|
3726.75 ng*hr/mL
Standard Deviation 1616.928
|
2051.37 ng*hr/mL
Standard Deviation 885.185
|
—
|
—
|
|
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite
Day 15 (M-I) (n=6, 6, 5)
|
2042.91 ng*hr/mL
Standard Deviation 995.133
|
2413.78 ng*hr/mL
Standard Deviation 935.159
|
2010.24 ng*hr/mL
Standard Deviation 993.327
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: predose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite
Day 1 (MLN3126) (n=6, 6, 6)
|
29005.04 ng*hr/mL
Standard Deviation 4679.572
|
56338.09 ng*hr/mL
Standard Deviation 15089.327
|
36073.07 ng*hr/mL
Standard Deviation 8916.201
|
—
|
—
|
|
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite
Day 15 (MLN3126) (n=6, 6, 5)
|
19328.57 ng*hr/mL
Standard Deviation 4036.507
|
33250.14 ng*hr/mL
Standard Deviation 7370.421
|
23046.44 ng*hr/mL
Standard Deviation 6603.581
|
—
|
—
|
|
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite
Day 1 (M-I) (n=6, 6, 6)
|
2499.49 ng*hr/mL
Standard Deviation 1304.091
|
3747.82 ng*hr/mL
Standard Deviation 1631.659
|
2065.18 ng*hr/mL
Standard Deviation 892.563
|
—
|
—
|
|
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite
Day 15 (M-I) (n=6, 6, 5)
|
2068.13 ng*hr/mL
Standard Deviation 1008.064
|
2437.78 ng*hr/mL
Standard Deviation 949.142
|
2031.41 ng*hr/mL
Standard Deviation 997.685
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
CL/F: Apparent Oral Clearance of MLN3126 and Its Metabolite After Multiple Dosing (at Steady State)
MLN3126
|
4.76 liter per hour (L/hr)
Standard Deviation 0.740
|
7.64 liter per hour (L/hr)
Standard Deviation 1.989
|
3.87 liter per hour (L/hr)
Standard Deviation 1.132
|
—
|
—
|
|
CL/F: Apparent Oral Clearance of MLN3126 and Its Metabolite After Multiple Dosing (at Steady State)
M-I
|
NA liter per hour (L/hr)
Standard Deviation NA
As pre-specified in protocol, oral clearance was only calculated for parent drug (MLN3126) and not for metabolite (M-I), hence data is reported for only MLN3126.
|
NA liter per hour (L/hr)
Standard Deviation NA
As pre-specified in protocol, oral clearance was only calculated for parent drug (MLN3126) and not for metabolite (M-I), hence data is reported for only MLN3126.
|
NA liter per hour (L/hr)
Standard Deviation NA
As pre-specified in protocol, oral clearance was only calculated for parent drug (MLN3126) and not for metabolite (M-I), hence data is reported for only MLN3126.
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite
Day 1 (MLN3126) (n=6, 6, 6)
|
12.901 hours
Standard Deviation 0.9029
|
13.717 hours
Standard Deviation 0.9151
|
12.830 hours
Standard Deviation 1.9144
|
—
|
—
|
|
Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite
Day 15 (MLN3126) (n=6, 6, 5)
|
13.459 hours
Standard Deviation 0.5482
|
12.308 hours
Standard Deviation 0.9315
|
12.727 hours
Standard Deviation 1.0056
|
—
|
—
|
|
Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite
Day 1 (M-I) (n=6, 6, 6)
|
14.901 hours
Standard Deviation 2.7546
|
13.131 hours
Standard Deviation 2.9209
|
13.374 hours
Standard Deviation 4.6494
|
—
|
—
|
|
Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite
Day 15 (M-I) (n=6, 6, 5)
|
16.644 hours
Standard Deviation 3.2368
|
13.724 hours
Standard Deviation 2.0905
|
15.086 hours
Standard Deviation 3.2709
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Cav: Average Plasma Concentration for MLN3126 and Its Metabolite on Day 1
M-I
|
84.46 ng/mL
Standard Deviation 43.261
|
122.32 ng/mL
Standard Deviation 49.186
|
71.74 ng/mL
Standard Deviation 32.035
|
—
|
—
|
|
Cav: Average Plasma Concentration for MLN3126 and Its Metabolite on Day 1
MLN3126
|
892.89 ng/mL
Standard Deviation 135.079
|
1727.16 ng/mL
Standard Deviation 430.824
|
1139.34 ng/mL
Standard Deviation 263.254
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=5 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Cavss: Average Plasma Concentration for MLN3126 and Its Metabolite at Steady State on Day 15
MLN3126
|
656.20 ng/mL
Standard Deviation 151.354
|
1098.04 ng/mL
Standard Deviation 234.426
|
756.95 ng/mL
Standard Deviation 188.168
|
—
|
—
|
|
Cavss: Average Plasma Concentration for MLN3126 and Its Metabolite at Steady State on Day 15
M-I
|
70.75 ng/mL
Standard Deviation 35.716
|
80.00 ng/mL
Standard Deviation 28.723
|
68.09 ng/mL
Standard Deviation 35.408
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Rac AUC(0-96): Accumulation Ratio of AUC(0-96) for MLN3126 and Its Metabolite
MLN3126
|
0.66572 ratio
Standard Deviation 0.084399
|
0.60172 ratio
Standard Deviation 0.082195
|
0.64024 ratio
Standard Deviation 0.077509
|
—
|
—
|
|
Rac AUC(0-96): Accumulation Ratio of AUC(0-96) for MLN3126 and Its Metabolite
M-I
|
0.84423 ratio
Standard Deviation 0.113307
|
0.65535 ratio
Standard Deviation 0.100968
|
0.89068 ratio
Standard Deviation 0.090814
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Cmax Ratio: Ratio of Maximum Plasma Concentration Between MLN3126 and Its Metabolite
Day 1
|
0.0781 ratio
Standard Deviation 0.02078
|
0.0732 ratio
Standard Deviation 0.02842
|
0.0595 ratio
Standard Deviation 0.01627
|
—
|
—
|
|
Cmax Ratio: Ratio of Maximum Plasma Concentration Between MLN3126 and Its Metabolite
Day 15
|
0.0774 ratio
Standard Deviation 0.02228
|
0.0578 ratio
Standard Deviation 0.01890
|
0.0663 ratio
Standard Deviation 0.02617
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.
M-I is the inactive metabolite of MLN3126.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 Participants
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 Participants
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Ratio of AUC(0-tau): Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Between MLN3126 and Its Metabolite
Day 1
|
0.0909 ratio
Standard Deviation 0.03620
|
0.0722 ratio
Standard Deviation 0.02894
|
0.0621 ratio
Standard Deviation 0.01972
|
—
|
—
|
|
Ratio of AUC(0-tau): Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Between MLN3126 and Its Metabolite
Day 15
|
0.1055 ratio
Standard Deviation 0.04173
|
0.0727 ratio
Standard Deviation 0.02549
|
0.0898 ratio
Standard Deviation 0.04073
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dosePopulation: Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.
M-I is the inactive metabolite of MLN3126.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dosePopulation: Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.
M-I is the inactive metabolite of MLN3126.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dosePopulation: Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.
CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr). M-I is the inactive metabolite of MLN3126.
Outcome measures
Outcome data not reported
Adverse Events
Part A: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: MLN3126 100 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: MLN3126 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: MLN3126 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Placebo
n=3 participants at risk
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 100 mg
n=6 participants at risk
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part A: MLN3126 300 mg
n=6 participants at risk
MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: Placebo
n=2 participants at risk
MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
Part B: MLN3126 100 mg
n=6 participants at risk
MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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
Somnolence
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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
Feeling hot
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 7 days after the last dose of double-blind study drug (Day 22 in each part).
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 No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER