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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1162-6078 | Registry Identifier | WHO | |
| JapicCTI-142691 | Registry Identifier | JapicCTI (Japan) |
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The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese male participants.
The study is composed of three parts, Single-dose Ascending Part, Food Effect Part and Multiple-dose Ascending Part. Single-dose Ascending Part and Multiple-dose Ascending Part are designed as a randomized, double-blind or open-label, placebo-controlled, sequential-cohort, ascending single or multiple oral dose study of TAK-114 or matched placebo. The Food Effect Part is designed as a randomized, open-label, 2-period crossover study of a single dose of TAK-114.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1A: TAK-114 10 mg | Experimental | Orally, once only. |
|
| Cohort 1B: TAK-114 10 mg | Experimental | Orally, once |
|
| Cohort 2A: TAK-114 20 mg | Experimental | Orally, once |
|
| Cohort 2B: TAK-114 20 mg | Experimental | Orally, once |
|
| Cohort 3A: TAK-114 50 mg | Experimental | Orally, once |
|
| Cohort 3B: TAK-114 50 mg | Experimental | Orally, once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-114 10 mg capsule | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3) | |
| Number of Participants With TEAEs Related to Vital Signs | Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3 | |
| Number of Participants With TEAEs Related to Body Weight | Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3 | |
| Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | Number of participants who had ECG shifts from "within normal limit" at baseline to "abnormal, clinically significant" after study drug administration were reported. | Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3 |
| Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1 | |
| Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Plasma Concentration for TAK-114 | Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3 | |
| AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 |
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Inclusion Criteria:
Healthy Japanese participants:
Healthy Caucasian participants:
Exclusion Criteria:
• Participants have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Takeda | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida-ku | Tokyo | Japan |
Healthy Japanese, Caucasian participants enrolled in study with 3 parts to receive TAK-114 single rising dose (SRD) (10 milligram [mg], 20 mg and 50 mg, once daily) in Part 1, TAK-114 20 mg in fasted and fed conditions, cross-over in Period 1 and 2 of food effect Part 2 and TAK-114 multiple rising dose (MRD) (20 mg, 50 mg twice daily) in Part 3.
Participants took part in the study at 1 investigative site in Japan from 17 Nov 2014 to 29 April 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 SRD-Cohort 1A - 3A: Placebo | TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
| FG001 | Part 1 SRD-Cohort 1A: TAK-114 10 mg | TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
| FG002 | Part 1 SRD-Cohort 2A: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
| FG003 | Part 1 SRD-Cohort 3A: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
| FG004 | Part 1 SRD - Cohort 1B : TAK-114 10 mg | TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. |
| FG005 | Part 1 SRD-Cohort 2B: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. |
| FG006 | Part 1 SRD-Cohort 3B: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. |
| FG007 | Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed | TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants. |
| FG008 | Part 2 Cohort 4: TAK-114 Fed + TAK-114 Fasted | TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 2 (3 days), in Japanese participants. |
| FG009 | Part 3 Placebo Cohort 5A - 6A: Placebo | TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. |
| FG010 | Part 3 Cohort 5A MRD: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. |
| FG011 | Part 3 Cohort 6A MRD: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. |
| FG012 | Part 3 Cohort 5B MRD: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants. |
| FG013 | Part 3 Cohort 6B MRD: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All Parts (16 Days) |
| |||||||||||||
| Washout Crossover Period(Part 2:14 Days) |
| |||||||||||||
| Crossover Treatment (Part 2: 3 Days) |
|
The safety analysis set was defined as all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 SRD-Cohort 1A - 3A: Placebo | TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
| BG001 | Part 1 SRD-Cohort 1A: TAK-114 10 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | The safety analysis set includes all participants who received the study drug. | Posted | Number | participants | Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3) |
|
Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3).
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 SRD-Cohort 1A - 3A: Placebo | TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Cohort 4a: TAK-114 20 mg |
| Experimental |
Period 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast |
|
| Cohort 4b: TAK-114 20 mg | Experimental | Period 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state |
|
| Cohort 5A: TAK-114 20 mg | Experimental | Orally, Twice daily, 10 days |
|
| Cohort 5B: TAK-114 20 mg | Experimental | Orally, Twice daily, 10 days |
|
| Cohort 6A: TAK-114 50 mg | Experimental | Orally, Twice daily, 10 days |
|
| Cohort 6B: TAK-114 50 mg | Experimental | Orally, Twice daily, 10 days |
|
| Cohort 1A, 2A, 3A: TAK-114 placebo | Placebo Comparator | Cohort 1A, 2A, 3A: Orally, once |
|
| Cohort 5A: TAK-114 placebo | Placebo Comparator | Cohort 5A: Orally, Twice daily, 10 days |
|
| Cohort 6A: TAK-114 placebo | Placebo Comparator | Cohort 6A: Orally, Twice daily, 10 days |
|
| TAK-114 matched placebo | Drug |
|
| Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2 |
| AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3 | Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3 |
| Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3 |
| Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3 | Mean R(Cmax) was estimated as the ratio of Cmax on Day 10 and Cmax on Day 1. Cmax is the peak plasma drug concentration of TAK-114. | Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3 |
| Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3 | Mean R(AUC) was estimated as the ratio of AUC(0-tau) on Day 10 and AUC(0-tau) on Day 1. AUC (0-tau) is the area under the plasma concentration-time curve from time 0 to time tau. | Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3 |
| Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 | Urinary excretion ratio (% of dose) of TAK-114 in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected. | Day 1: 0 to 48 hours postdose |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
| BG002 | Part 1 SRD-Cohort 2A: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
| BG003 | Part 1 SRD-Cohort 3A: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
| BG004 | Part 1 SRD - Cohort 1B : TAK-114 10 mg | TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. |
| BG005 | Part 1 SRD-Cohort 2B: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. |
| BG006 | Part 1 SRD-Cohort 3B: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. |
| BG007 | Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed | TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants. |
| BG008 | Part 2 Cohort 4: TAK-114 20 mg Fed + TAK-114 20 mg Fasted | TAK-114 20 mg, capsule, orally, once on Day 1, fed state in period 2 (3 days), followed by a 14 day washout period, further followed by TAK-114 20 mg, capsule, orally, once on Day 1 in fasted state in period 1, in healthy Japanese participants. |
| BG009 | Part 3 Placebo Cohort 5A - 6A: Placebo | TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. |
| BG010 | Part 3 Cohort 5A MRD: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. |
| BG011 | Part 3 Cohort 6A MRD: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. |
| BG012 | Part 3 Cohort 5B MRD: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants. |
| BG013 | Part 3 Cohort 6B MRD: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants. |
| BG014 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | All participants enrolled in the study were male. | Number | Participants |
|
| Alcohol Classification | Number | Participants |
|
| Caffeine Classification | Number | Participants |
|
| Smoking Classification | Number | Participants |
|
| OG002 | Part 1 SRD-Cohort 2A: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
| OG003 | Part 1 SRD-Cohort 3A: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. |
| OG004 | Part 1 SRD - Cohort 1B : TAK-114 10 mg | TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. |
| OG005 | Part 1 SRD-Cohort 2B: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. |
| OG006 | Part 1 SRD-Cohort 3B: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. |
| OG007 | Part 2 Cohort 4: TAK-114 20 mg Fasted | TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants. |
| OG008 | Part 2 Cohort 4: TAK-114 20 mg Fed | TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants. |
| OG009 | Part 3 Placebo Cohort 5A - 6A: Placebo | TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. |
| OG010 | Part 3 Cohort 5A MRD: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. |
| OG011 | Part 3 Cohort 6A MRD: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. |
| OG012 | Part 3 Cohort 5B MRD: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants. |
| OG013 | Part 3 Cohort 6B MRD: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants. |
|
|
| Primary | Number of Participants With TEAEs Related to Vital Signs | The safety analysis set includes all participants who received the study drug. | Posted | Number | participants | Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3 |
|
|
|
| Primary | Number of Participants With TEAEs Related to Body Weight | The safety analysis set includes all participants who received the study drug. | Posted | Number | participants | Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3 |
|
|
|
| Primary | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | Number of participants who had ECG shifts from "within normal limit" at baseline to "abnormal, clinically significant" after study drug administration were reported. | The safety analysis set includes all participants who received the study drug. | Posted | Number | participants | Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3 |
|
|
|
| Primary | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | The safety analysis set includes all participants who received the study drug. | Posted | Number | participants | Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1 |
|
|
|
| Primary | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | The safety analysis set includes all participants who received the study drug. | Posted | Number | participants | Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3 |
|
|
|
| Secondary | Cmax - Maximum Observed Plasma Concentration for TAK-114 | The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3 |
|
|
|
| Secondary | AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Mean | Standard Deviation | picogram*hour per milliliter (pg*hr/mL) | Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2 |
|
|
|
| Secondary | AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3 | The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Mean | Standard Deviation | pg*hr/mL | Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3 |
|
|
|
| Secondary | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Mean | Standard Deviation | hour | Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3 |
|
|
|
| Secondary | Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3 | Mean R(Cmax) was estimated as the ratio of Cmax on Day 10 and Cmax on Day 1. Cmax is the peak plasma drug concentration of TAK-114. | The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Mean | Standard Deviation | ratio | Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3 |
|
|
|
| Secondary | Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3 | Mean R(AUC) was estimated as the ratio of AUC(0-tau) on Day 10 and AUC(0-tau) on Day 1. AUC (0-tau) is the area under the plasma concentration-time curve from time 0 to time tau. | The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Mean | Standard Deviation | ratio | Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3 |
|
|
|
| Secondary | Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 | Urinary excretion ratio (% of dose) of TAK-114 in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected. | The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Mean | Standard Deviation | percentage of dose | Day 1: 0 to 48 hours postdose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Part 1 SRD-Cohort 1A: TAK-114 10 mg | TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. | 0 | 6 | 0 | 6 |
| EG002 | Part 1 SRD-Cohort 2A: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. | 0 | 6 | 1 | 6 |
| EG003 | Part 1 SRD-Cohort 3A: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants. | 0 | 6 | 1 | 6 |
| EG004 | Part 1 SRD - Cohort 1B : TAK-114 10 mg | TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. | 0 | 6 | 1 | 6 |
| EG005 | Part 1 SRD-Cohort 2B: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. | 0 | 6 | 0 | 6 |
| EG006 | Part 1 SRD-Cohort 3B: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants. | 0 | 6 | 1 | 6 |
| EG007 | Part 2 Cohort 4: TAK-114 20 mg Fasted | TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants. | 0 | 12 | 0 | 12 |
| EG008 | Part 2 Cohort 4: TAK-114 20 mg Fed | TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants. | 0 | 12 | 1 | 12 |
| EG009 | Part 3 Placebo Cohort 5A - 6A: Placebo | TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. | 0 | 4 | 0 | 4 |
| EG010 | Part 3 Cohort 5A MRD: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. | 0 | 6 | 3 | 6 |
| EG011 | Part 3 Cohort 6A MRD: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants. | 0 | 6 | 5 | 6 |
| EG012 | Part 3 Cohort 5B MRD: TAK-114 20 mg | TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants. | 0 | 6 | 2 | 6 |
| EG013 | Part 3 Cohort 6B MRD: TAK-114 50 mg | TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants. | 0 | 6 | 6 | 6 |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| High density lipoprotein decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
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.
| White blood cell count increased |
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Blood triglycerides increased |
|
| Haemoglobin decreased |
|
| High density lipoprotein decreased |
|