Clinical Pharmacology
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTAK-114 10 mg capsule
DRUGTAK-114 matched placebo
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Japanese participants: * Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol. * Is aged 20 to 45 years, inclusive. * Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2). Healthy Caucasian participants: * Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol. * Is aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents and grandparents and has lived outside original country for less than 5 years) and maintains their original diet and lifestyle. * Weighs at least 50 kg and have a body mass index between 18.5 and 30.0 kg/m2.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3 | Number of participants who had ECG shifts from within normal limit at baseline to abnormal, clinically significant after study drug administration were reported. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for 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. |
| 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 | — |
| Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 | Day 1: 0 to 48 hours postdose | 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. |
| AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | 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 | Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Japan from 17 Nov 2014 to 29 April 2015.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| 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. | 4 |
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| Total | 82 |
Baseline characteristics
| Characteristic | Part 1 SRD-Cohort 1A: TAK-114 10 mg | Part 1 SRD-Cohort 2A: TAK-114 20 mg | Part 1 SRD-Cohort 3A: TAK-114 50 mg | Part 1 SRD - Cohort 1B : TAK-114 10 mg | Part 1 SRD-Cohort 2B: TAK-114 20 mg | Part 1 SRD-Cohort 3B: TAK-114 50 mg | Part 1 SRD-Cohort 1A - 3A: Placebo | Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed | Part 2 Cohort 4: TAK-114 20 mg Fed + TAK-114 20 mg Fasted | Part 3 Placebo Cohort 5A - 6A: Placebo | Part 3 Cohort 5A MRD: TAK-114 20 mg | Part 3 Cohort 6A MRD: TAK-114 50 mg | Part 3 Cohort 5B MRD: TAK-114 20 mg | Part 3 Cohort 6B MRD: TAK-114 50 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Age | 29.8 Years STANDARD_DEVIATION 7.25 | 28.3 Years STANDARD_DEVIATION 10.27 | 34.2 Years STANDARD_DEVIATION 10.26 | 32.0 Years STANDARD_DEVIATION 7.24 | 30.3 Years STANDARD_DEVIATION 5.65 | 26.3 Years STANDARD_DEVIATION 4.97 | 31.5 Years STANDARD_DEVIATION 8.48 | 25.5 Years STANDARD_DEVIATION 3.51 | 35.3 Years STANDARD_DEVIATION 8.12 | 41.0 Years STANDARD_DEVIATION 4.08 | 30.3 Years STANDARD_DEVIATION 9.22 | 33.7 Years STANDARD_DEVIATION 10.73 | 29.3 Years STANDARD_DEVIATION 5.54 | 33.2 Years STANDARD_DEVIATION 5.74 | 31.3 Years STANDARD_DEVIATION 7.87 |
| Alcohol Classification Does not drink | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 19 Participants |
| Alcohol Classification Drinks a Few Days per Month | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 12 Participants |
| Alcohol Classification Drinks a Few Days per Week | 1 Participants | 5 Participants | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 2 Participants | 1 Participants | 5 Participants | 1 Participants | 2 Participants | 3 Participants | 5 Participants | 4 Participants | 44 Participants |
| Alcohol Classification Drinks Every Day | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 7 Participants |
| Caffeine Classification Caffeine Consumption | 6 Participants | 3 Participants | 6 Participants | 4 Participants | 6 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 2 Participants | 4 Participants | 4 Participants | 5 Participants | 6 Participants | 64 Participants |
| Caffeine Classification No Caffeine Consumption | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 18 Participants |
| Sex/Gender, Customized Male | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 82 Participants |
| Smoking Classification Ex-smoker | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 30 Participants |
| Smoking Classification Never smoked | 5 Participants | 3 Participants | 3 Participants | 5 Participants | 5 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 1 Participants | 3 Participants | 5 Participants | 4 Participants | 4 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 1 / 6 | 1 / 6 | 1 / 6 | 0 / 6 | 1 / 6 | 0 / 12 | 1 / 12 | 0 / 4 | 3 / 6 | 5 / 6 | 2 / 6 | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 12 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Time frame: 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)
Population: The safety analysis set includes all participants who received the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 1 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 1 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 1 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 1 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 1 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 0 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 3 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 5 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 2 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 6 participants |
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.
Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Population: The safety analysis set includes all participants who received the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants |
Primary
Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Time frame: Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1
Population: The safety analysis set includes all participants who received the study drug.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants | 0 |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants | 0 |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants | 0 |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG) | 0 participants | 0 |
Primary
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Population: The safety analysis set includes all participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 1 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 1 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 1 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 1 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 1 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 1 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 1 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 1 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 0 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 1 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 1 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Aspartate aminotransferase increased | 0 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | White blood cell count increased | 0 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | C-reactive protein increased | 3 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Blood triglycerides increased | 0 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Haemoglobin decreased | 0 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | Alanine aminotransferase increased | 0 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | High density lipoprotein decreased | 1 participants |
Primary
Number of Participants With TEAEs Related to Body Weight
Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Population: The safety analysis set includes all participants who received the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With TEAEs Related to Body Weight | 0 participants |
Primary
Number of Participants With TEAEs Related to Vital Signs
Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Population: The safety analysis set includes all participants who received the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 3 Cohort 5B MRD: TAK-114 20 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
| Part 3 Cohort 6B MRD: TAK-114 50 mg | Number of Participants With TEAEs Related to Vital Signs | 0 participants |
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
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | 469.2 picogram*hour per milliliter (pg*hr/mL) | Standard Deviation 112.44 |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | 762.2 picogram*hour per milliliter (pg*hr/mL) | Standard Deviation 195.14 |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | 1708 picogram*hour per milliliter (pg*hr/mL) | Standard Deviation 607.24 |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | 472.3 picogram*hour per milliliter (pg*hr/mL) | Standard Deviation 77.694 |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | 879.2 picogram*hour per milliliter (pg*hr/mL) | Standard Deviation 142.15 |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | 2180 picogram*hour per milliliter (pg*hr/mL) | Standard Deviation 405.22 |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | 918.9 picogram*hour per milliliter (pg*hr/mL) | Standard Deviation 165.75 |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2 | 918.2 picogram*hour per milliliter (pg*hr/mL) | Standard Deviation 197.12 |
Secondary
AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3
Time frame: Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3 | 251.3 pg*hr/mL | Standard Deviation 47.209 |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3 | 838.0 pg*hr/mL | Standard Deviation 140.39 |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3 | 183.2 pg*hr/mL | Standard Deviation 49.061 |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3 | 749.7 pg*hr/mL | Standard Deviation 243.56 |
Secondary
Cmax - Maximum Observed Plasma Concentration for TAK-114
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 53.15 picogram per milliliter (pg/mL) | Standard Deviation 10.051 |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 68.74 picogram per milliliter (pg/mL) | Standard Deviation 26.789 |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 168.1 picogram per milliliter (pg/mL) | Standard Deviation 71.21 |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 30.98 picogram per milliliter (pg/mL) | Standard Deviation 14.822 |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 74.72 picogram per milliliter (pg/mL) | Standard Deviation 17.886 |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 140.8 picogram per milliliter (pg/mL) | Standard Deviation 47.499 |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 98.12 picogram per milliliter (pg/mL) | Standard Deviation 34.944 |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 150.8 picogram per milliliter (pg/mL) | Standard Deviation 56.655 |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 39.37 picogram per milliliter (pg/mL) | Standard Deviation 4.843 |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 112.6 picogram per milliliter (pg/mL) | Standard Deviation 12.857 |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 24.53 picogram per milliliter (pg/mL) | Standard Deviation 7.1949 |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Cmax - Maximum Observed Plasma Concentration for TAK-114 | 106.7 picogram per milliliter (pg/mL) | Standard Deviation 36.967 |
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.
Time frame: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | 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 | 0.3032 ratio | Standard Deviation 0.07024 |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | 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 | 0.4768 ratio | Standard Deviation 0.15749 |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | 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 | 0.3128 ratio | Standard Deviation 0.08596 |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | 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 | 0.4087 ratio | Standard Deviation 0.04966 |
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.
Time frame: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3 | 0.2368 ratio | Standard Deviation 0.05638 |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3 | 0.3606 ratio | Standard Deviation 0.10037 |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3 | 0.2125 ratio | Standard Deviation 0.06181 |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3 | 0.3190 ratio | Standard Deviation 0.0663 |
Secondary
Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 4.108 hour | Standard Deviation 0.76763 |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 5.500 hour | Standard Deviation 2.7925 |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 5.272 hour | Standard Deviation 2.0918 |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 7.417 hour | Standard Deviation 1.9012 |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 5.822 hour | Standard Deviation 0.75503 |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 6.213 hour | Standard Deviation 1.0856 |
| Part 1 SRD-Cohort 3B: TAK-114 50 mg | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 4.294 hour | Standard Deviation 1.06 |
| Part 2 Cohort 4: TAK-114 20 mg Fasted | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 3.705 hour | Standard Deviation 1.1044 |
| Part 2 Cohort 4: TAK-114 20 mg Fed | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 4.972 hour | Standard Deviation 1.6574 |
| Part 3 Placebo Cohort 5A - 6A: Placebo | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 6.970 hour | Standard Deviation 1.0813 |
| Part 3 Cohort 5A MRD: TAK-114 20 mg | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 6.045 hour | Standard Deviation 2.2456 |
| Part 3 Cohort 6A MRD: TAK-114 50 mg | Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114 | 7.283 hour | Standard Deviation 2.2407 |
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.
Time frame: Day 1: 0 to 48 hours postdose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 SRD-Cohort 1A - 3A: Placebo | Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 | 0.003835 percentage of dose | Standard Deviation 0.001999 |
| Part 1 SRD-Cohort 1A: TAK-114 10 mg | Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 | 0.001984 percentage of dose | Standard Deviation 0.00055667 |
| Part 1 SRD-Cohort 2A: TAK-114 20 mg | Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 | 0.002759 percentage of dose | Standard Deviation 0.0017349 |
| Part 1 SRD-Cohort 3A: TAK-114 50 mg | Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 | 0.003724 percentage of dose | Standard Deviation 0.0022022 |
| Part 1 SRD - Cohort 1B : TAK-114 10 mg | Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 | 0.003143 percentage of dose | Standard Deviation 0.000835 |
| Part 1 SRD-Cohort 2B: TAK-114 20 mg | Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1 | 0.002420 percentage of dose | Standard Deviation 0.0012154 |