Trial Outcomes & Findings for A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants (NCT NCT03706469)
NCT ID: NCT03706469
Last Updated: 2021-06-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Results posted on
2021-06-14
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 18 October 2018 to 22 December 2018.
Healthy participants were enrolled and randomized in one of the 4 treatment sequences to receive TAK-831.
Participant milestones
| Measure |
Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)
TAK-831 T2 50 milligram (mg), tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
|
Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
|
Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
|
Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
Baseline characteristics by cohort
| Measure |
Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)
n=4 Participants
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
|
Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)
n=4 Participants
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
|
Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)
n=4 Participants
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
|
Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)
n=4 Participants
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 8.49 • n=7 Participants
|
31.8 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 9.56 • n=4 Participants
|
37.8 years
STANDARD_DEVIATION 11.60 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Weight
|
80.48 kilogram (Kg)
STANDARD_DEVIATION 9.694 • n=5 Participants
|
67.55 kilogram (Kg)
STANDARD_DEVIATION 6.815 • n=7 Participants
|
70.63 kilogram (Kg)
STANDARD_DEVIATION 19.643 • n=5 Participants
|
76.07 kilogram (Kg)
STANDARD_DEVIATION 4.666 • n=4 Participants
|
73.68 kilogram (Kg)
STANDARD_DEVIATION 11.660 • n=21 Participants
|
|
Height
|
175.3 centimeter (cm)
STANDARD_DEVIATION 5.74 • n=5 Participants
|
168.3 centimeter (cm)
STANDARD_DEVIATION 6.65 • n=7 Participants
|
169.5 centimeter (cm)
STANDARD_DEVIATION 13.48 • n=5 Participants
|
169.3 centimeter (cm)
STANDARD_DEVIATION 2.06 • n=4 Participants
|
170.6 centimeter (cm)
STANDARD_DEVIATION 7.79 • n=21 Participants
|
|
Body mass index (BMI)
|
26.060 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.6219 • n=5 Participants
|
24.090 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.1222 • n=7 Participants
|
24.250 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.3966 • n=5 Participants
|
26.620 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.9483 • n=4 Participants
|
25.255 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.8796 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.
Outcome measures
| Measure |
TAK-831 T2 50 mg Fasted
n=16 Participants
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 50 mg Fasted
n=16 Participants
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T2 600 mg Fasted
n=16 Participants
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fasted
n=16 Participants
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fed
n=16 Participants
TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
|
|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
|
714.8 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 28.7
|
597.5 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 37.0
|
4563 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 24.8
|
4665 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 41.8
|
8058 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 29.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. The PK analysis population where data at specified time points were available.
Outcome measures
| Measure |
TAK-831 T2 50 mg Fasted
n=14 Participants
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 50 mg Fasted
n=11 Participants
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T2 600 mg Fasted
n=16 Participants
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fasted
n=14 Participants
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fed
n=15 Participants
TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
|
|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
|
761.8 ng*hr/mL
Geometric Coefficient of Variation 29.3
|
688.6 ng*hr/mL
Geometric Coefficient of Variation 31.0
|
4665 ng*hr/mL
Geometric Coefficient of Variation 26.0
|
4558 ng*hr/mL
Geometric Coefficient of Variation 41.8
|
7934 ng*hr/mL
Geometric Coefficient of Variation 27.3
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.
Outcome measures
| Measure |
TAK-831 T2 50 mg Fasted
n=16 Participants
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 50 mg Fasted
n=16 Participants
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T2 600 mg Fasted
n=16 Participants
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fasted
n=16 Participants
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fed
n=16 Participants
TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
|
|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-831
|
397.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.8
|
314.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.0
|
1384 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28.9
|
1381 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24.6
|
2394 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 37.1
|
SECONDARY outcome
Timeframe: Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47)Population: The safety analysis set included all participants who received at least one dose of the study drug(s).
Outcome measures
| Measure |
TAK-831 T2 50 mg Fasted
n=16 Participants
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 50 mg Fasted
n=16 Participants
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T2 600 mg Fasted
n=16 Participants
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fasted
n=16 Participants
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fed
n=16 Participants
TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
0 percentage of participants
|
13 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
0 percentage of participants
|
Adverse Events
TAK-831 T2 50 mg Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAK-831 T3 50 mg Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TAK-831 T2 600 mg Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAK-831 T3 600 mg Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TAK-831 T3 600 mg 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 |
TAK-831 T2 50 mg Fasted
n=16 participants at risk
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 50 mg Fasted
n=16 participants at risk
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T2 600 mg Fasted
n=16 participants at risk
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fasted
n=16 participants at risk
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
|
TAK-831 T3 600 mg Fed
n=16 participants at risk
TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
1/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/16 • Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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 Generally, the PI may publish results of the study following the publication of results by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER