Trial Outcomes & Findings for Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants (NCT NCT02396147)
NCT ID: NCT02396147
Last Updated: 2016-07-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
Results posted on
2016-07-25
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 02 March 2015 to 11 June 2015.
Healthy participants were enrolled equally in 1 of 2 treatment arms each with 6 sequences that determined the order of administration of TAK-385 tablet formulations. Arm 1: T2 fasted, T4 B fasted or T4 B fed and Arm 2: T2 fasted, T4 C fasted or T4 C fed.
Participant milestones
| Measure |
Arm 1: T2-A + T4B-B + T4B-C
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
|
Arm 2: T2-A + T4C-D + T4C-E
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
|
|---|---|---|
|
Period 1
STARTED
|
27
|
27
|
|
Period 1
COMPLETED
|
27
|
27
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
27
|
27
|
|
Period 2
COMPLETED
|
27
|
27
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
27
|
27
|
|
Period 3
COMPLETED
|
27
|
27
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants
Baseline characteristics by cohort
| Measure |
Arm 1: T2-A + T4B-B + T4B-C
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
|
Arm 2: T2-A + T4C-D + T4C-E
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 11.62 • n=93 Participants
|
38.8 years
STANDARD_DEVIATION 10.08 • n=4 Participants
|
38.9 years
STANDARD_DEVIATION 10.78 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
23 participants
n=93 Participants
|
21 participants
n=4 Participants
|
44 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
21 participants
n=93 Participants
|
14 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 participants
n=93 Participants
|
13 participants
n=4 Participants
|
19 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
27 participants
n=4 Participants
|
54 participants
n=27 Participants
|
|
Weight
|
83.07 kg
STANDARD_DEVIATION 11.957 • n=93 Participants
|
83.69 kg
STANDARD_DEVIATION 13.678 • n=4 Participants
|
83.38 kg
STANDARD_DEVIATION 12.729 • n=27 Participants
|
|
Height
|
174.3 cm
STANDARD_DEVIATION 10.10 • n=93 Participants
|
175.4 cm
STANDARD_DEVIATION 6.79 • n=4 Participants
|
174.8 cm
STANDARD_DEVIATION 8.54 • n=27 Participants
|
|
Body Mass Index
|
27.311 kg/m^2
STANDARD_DEVIATION 2.7624 • n=93 Participants
|
27.148 kg/m^2
STANDARD_DEVIATION 3.6504 • n=4 Participants
|
27.230 kg/m^2
STANDARD_DEVIATION 3.2074 • n=27 Participants
|
PRIMARY outcome
Timeframe: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dosePopulation: Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=26 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-385
|
46.7 ng/mL
Geometric Coefficient of Variation 114.9
|
42.0 ng/mL
Geometric Coefficient of Variation 153.1
|
33.0 ng/mL
Geometric Coefficient of Variation 115.5
|
52.0 ng/mL
Geometric Coefficient of Variation 93.3
|
43.5 ng/mL
Geometric Coefficient of Variation 146.8
|
41.2 ng/mL
Geometric Coefficient of Variation 105.9
|
PRIMARY outcome
Timeframe: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dosePopulation: PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=26 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385
|
447 ng•hr/mL
Geometric Coefficient of Variation 64.7
|
440 ng•hr/mL
Geometric Coefficient of Variation 83.3
|
350 ng•hr/mL
Geometric Coefficient of Variation 65.0
|
532 ng•hr/mL
Geometric Coefficient of Variation 55.4
|
415 ng•hr/mL
Geometric Coefficient of Variation 85.1
|
386 ng•hr/mL
Geometric Coefficient of Variation 52.4
|
PRIMARY outcome
Timeframe: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dosePopulation: PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=26 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
|
476 ng*hr/mL
Geometric Coefficient of Variation 63.5
|
467 ng*hr/mL
Geometric Coefficient of Variation 82.8
|
372 ng*hr/mL
Geometric Coefficient of Variation 64.1
|
563 ng*hr/mL
Geometric Coefficient of Variation 55.1
|
440 ng*hr/mL
Geometric Coefficient of Variation 84.8
|
409 ng*hr/mL
Geometric Coefficient of Variation 51.8
|
SECONDARY outcome
Timeframe: From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)Population: Safety population included all participants who received at least 1 dose of study drug.
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=27 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
4 percentage of participants
|
7 percentage of participants
|
7 percentage of participants
|
4 percentage of participants
|
4 percentage of participants
|
7 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 10, 14, 20, 24 and 26Population: Safety population included all participants who received at least 1 dose of study drug.
Participants with shifts from normal at Baseline in safety laboratory values (Clinical Chemistry, Hematology and Urinalysis) collected throughout study. Low=below normal reference range, Normal=within reference range, High=above normal reference range and Abnormal=outside of normal reference range.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=27 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Aspartate aminotransferase (AST)_Normal to Low
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Chloride_Normal to Low
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Creatinine_Normal to High
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Sodium_Normal to High
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Urate_Normal to Low
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Urate_Normal to High
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Basophils_Normal to High
|
3 participants
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Lymphocytes_Normal to High
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Monocytes_Normal to High
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Absolute Monocytes_Normal to High
|
2 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Neutrophils_Normal to Low
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Absolute neutrophils_Normal to Low
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Occult blood_Normal to Abnormal
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Specific gravity_Normal to Abnormal
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1, 11, 21 and 26Population: Safety population included all participants who received at least 1 dose of study drug.
A 12-lead ECG was administered. The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=27 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 26Population: Safety population included all participants who received at least 1 dose of study drug.
The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=27 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dosePopulation: Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=27 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
|
2.01 hours
Interval 0.5 to 6.0
|
3.00 hours
Interval 0.502 to 12.0
|
3.00 hours
Interval 0.5 to 8.0
|
3.00 hours
Interval 0.499 to 6.02
|
3.00 hours
Interval 0.499 to 12.0
|
3.00 hours
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dosePopulation: Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=27 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Half-Life (T1/2) for TAK-385
|
36.3 hours
Standard Deviation 4.40
|
36.1 hours
Standard Deviation 4.90
|
35.1 hours
Standard Deviation 4.11
|
34.9 hours
Standard Deviation 4.13
|
35.5 hours
Standard Deviation 4.22
|
35.4 hours
Standard Deviation 2.97
|
SECONDARY outcome
Timeframe: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dosePopulation: Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.
Outcome measures
| Measure |
Arm 1: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=26 Participants
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 Participants
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 Participants
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 Participants
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 Participants
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
Oral Clearance (CL/F) for TAK-385
|
252 liters (L)/hr
Geometric Coefficient of Variation 63.6
|
257 liters (L)/hr
Geometric Coefficient of Variation 82.7
|
322 liters (L)/hr
Geometric Coefficient of Variation 64.0
|
213 liters (L)/hr
Geometric Coefficient of Variation 55.1
|
273 liters (L)/hr
Geometric Coefficient of Variation 84.8
|
293 liters (L)/hr
Geometric Coefficient of Variation 51.9
|
Adverse Events
Arm 1: T2 Formulation Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 1: T4 Formulation B Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 1: T4 Formulation B Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2: T2 Formulation Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 2: T4 Formulation C Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 2: T4 Formulation C Fed
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 |
Arm 1: T2 Formulation Fasted
n=27 participants at risk
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fasted
n=27 participants at risk
T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 1: T4 Formulation B Fed
n=27 participants at risk
T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T2 Formulation Fasted
n=27 participants at risk
T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fasted
n=27 participants at risk
T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
Arm 2: T4 Formulation C Fed
n=27 participants at risk
T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
|
|---|---|---|---|---|---|---|
|
Eye disorders
Visual impairment
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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
Vessel puncture site pain
|
0.00%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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
Contusion
|
0.00%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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
Joint range of motion decreased
|
0.00%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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
Muscle spasms
|
0.00%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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
Pain in extremity
|
0.00%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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
Paraesthesia
|
0.00%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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
Presyncope
|
0.00%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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.
|
3.7%
1/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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%
0/27 • From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER