Trial Outcomes & Findings for A Bioequivalence Study of TAK-536 Pediatric Formulation (NCT NCT02401464)
NCT ID: NCT02401464
Last Updated: 2016-07-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Results posted on
2016-07-06
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 25 March 2015 to 26 May 2015.
Healthy participants were enrolled in 1 of 2 treatment sequences: Sequence a (dry syrup): TAK-536 dry syrup followed by TAK-536 tablet; Sequence b (dry syrup): TAK-536 tablet followed by TAK-536 dry syrup; Sequence a (granules): TAK-536 granules followed by TAK-536 tablet; Sequence b (granules): TAK-536 tablet followed by TAK-536 granules.
Participant milestones
| Measure |
Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet
Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
|
Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup
Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
|
Granule Cohort: TAK-536 Granules + TAK-536 Tablet
Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
|
Granule Cohort: TAK-536 Tablet + TAK-536 Granules
Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
|
|---|---|---|---|---|
|
Intervention Period 1 (6 Days)
STARTED
|
13
|
13
|
13
|
13
|
|
Intervention Period 1 (6 Days)
COMPLETED
|
13
|
13
|
13
|
13
|
|
Intervention Period 1 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period (At Least 6 Days)
STARTED
|
13
|
13
|
13
|
13
|
|
Washout Period (At Least 6 Days)
COMPLETED
|
13
|
13
|
13
|
13
|
|
Washout Period (At Least 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention Period 2 (6 Days)
STARTED
|
13
|
13
|
13
|
13
|
|
Intervention Period 2 (6 Days)
COMPLETED
|
13
|
13
|
13
|
13
|
|
Intervention Period 2 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Bioequivalence Study of TAK-536 Pediatric Formulation
Baseline characteristics by cohort
| Measure |
Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet
n=13 Participants
Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
|
Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup
n=13 Participants
Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
|
Granule Cohort: TAK-536 Granules + TAK-536 Tablet
n=13 Participants
Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
|
Granule Cohort: TAK-536 Tablet + TAK-536 Granules
n=13 Participants
Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Caffeine Classification
Had no caffeine consumption
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Age, Continuous
|
25.3 years
STANDARD_DEVIATION 2.21 • n=5 Participants
|
25.9 years
STANDARD_DEVIATION 4.11 • n=7 Participants
|
26.6 years
STANDARD_DEVIATION 4.07 • n=5 Participants
|
27.4 years
STANDARD_DEVIATION 5.71 • n=4 Participants
|
26.308 years
STANDARD_DEVIATION 4.16 • n=21 Participants
|
|
Sex/Gender, Customized
Male
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
13 participants
n=4 Participants
|
52 participants
n=21 Participants
|
|
Smoking classification
Never smoked
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
31 participants
n=21 Participants
|
|
Smoking classification
Current smoker
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Smoking classification
Ex-smoker
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Alcohol classification
Drank a few days per week
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Alcohol classification
Drank a few days per month
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Alcohol classification
Never drank
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
37 participants
n=21 Participants
|
|
Caffeine Classification
Had caffeine consumption
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
16 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.
Outcome measures
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort
|
7065.6 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1317.91
|
7341.2 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1493.71
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.
Outcome measures
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort
|
886.1 nanogram per milliliter (ng/mL)
Standard Deviation 133.76
|
976.7 nanogram per milliliter (ng/mL)
Standard Deviation 140.97
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.
Outcome measures
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort
|
7749.8 ng*hr/mL
Standard Deviation 1188.80
|
7893.2 ng*hr/mL
Standard Deviation 1336.61
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.
Outcome measures
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort
|
943.2 ng/mL
Standard Deviation 106.76
|
973.7 ng/mL
Standard Deviation 178.75
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2Population: The safety analysis set included all participants who received the study drug at least once.
Outcome measures
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
5 participants
|
5 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2Population: The safety analysis set included all participants who received the study drug at least once.
Outcome measures
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Vital Signs
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2Population: The safety analysis set included all participants who received the study drug at least once.
Outcome measures
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Body Weight
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2Population: The safety analysis set included all participants who received the study drug at least once.
Outcome measures
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2Population: The safety analysis set included all participants who received the study drug at least once.
Outcome measures
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
n=26 Participants
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
n=26 Participants
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
|
4 participants
|
5 participants
|
0 participants
|
2 participants
|
Adverse Events
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Granule Cohort: TAK-536 10 mg Pediatric Formulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Granule Cohort: TAK-536 10 mg Commercial Formulation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation
n=26 participants at risk
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
|
Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
n=26 participants at risk
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Pediatric Formulation
n=26 participants at risk
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
Granule Cohort: TAK-536 10 mg Commercial Formulation
n=26 participants at risk
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
7.7%
2/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
|
Investigations
Protein urine present
|
7.7%
2/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
|
Investigations
Blood triglycerides increased
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
|
Investigations
Blood urine present
|
0.00%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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
Headache
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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%
0/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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.
|
3.8%
1/26 • Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention Period 2).
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