Healthy Volunteers
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single- and multiple-doses of TAK-020 in healthy participants.
Detailed description
The drug being tested in this study is called TAK-020. TAK-020 is being tested to evaluate safety and tolerability of single doses and 7 days multiple doses of TAK-020 in healthy volunteers. This study will look at the PK characteristics (how the drug acts throughout the body) of the drug and safety and tolerability (lab results, vital signs, ECG, and side effects) in healthy participants who take TAK-020. The study will enroll a total of approximately 120 participants. This study is designed to consist of 2 sequential parts: Part 1-a SRD, and Part 2-a MRD. Healthy participants for Part 1 will be enrolled into 9 cohorts. Each cohort will have 8 randomized participants with receiving a single dose of TAK-020, and 2 receiving matching placebo under fasted conditions. In Cohorts 1-9 doses of 0.1, 0.5, 2.5, 4.4, 8.8, 17.5, 35, 70 and 105 mg will be evaluated. Healthy participants for Part 2 will be enrolled into 7 cohorts. Each cohort will have 8 randomized participants, with participants receiving one dose of TAK-020 on Day 1, followed by a washout on Day 2, then daily dosing on Days 3-9 of TAK-020 with 2 participants receiving matching placebo under fasted conditions. In Cohorts 1-4 doses of 3.75, 5.75, 13 and 25 mg will be evaluated. For Cohorts 5-7, the subsequent dose level is to be determined based on data from Part 1 and review of safety, tolerability and PK data from Part 2 Cohorts 1-4. This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 45 days. Participants in Part 1 will make multiple visits to the clinic including a period of confinement to the clinic and will be contacted by telephone 14 days after the last dose of study drug for a follow-up assessment. Participants in Part 2 will make multiple visits to the clinic including a period of confinement to the clinic and will be observed at the clinic 17 days after the last dose of study drug for a follow-up assessment.
Interventions
DRUGTAK-020 Placebo
TAK-020 placebo-matching oral solution
DRUGTAK-020
TAK-020 oral solution
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Participant eligibility is determined according to the following criteria prior to entry into the study: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. Participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations. 3. Participant is a healthy adult male or female. 4. The participant is a health adult male or female aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose. 5. The participant weighs at least 45 kilogram (kg) and has a body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m\^2), inclusive at Screening and Day -1. 6. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose. 7. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use adequate contraception from signing of informed consent throughout the duration of the study and until the next menstrual period or 30 days after last dose, whichever is first. If the next menstrual period is delayed, a pregnancy test will be required for exclusion of pregnancy.
Exclusion criteria
Any participant who meets any of the following criteria will not qualify for entry into the study: 1. The participant has received any investigational compound within 30 days prior to Screening. 2. The participant is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress. 3. Participant has a known hypersensitivity to any component of the formulation of TAK-020, Captisol or related compounds. 4. The participant has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1). 5. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as 4 or more alcoholic beverages per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine. 6. Participant has taken any excluded medication, supplements, or food products, Prohibited Medications and Dietary Products. 7. If female, the participant is pregnant or lactating or intending to become pregnant before, during or within 1 month after exit from this study (30 days post last dose); or intending to donate ova during such time period. 8. If male, the participant intends to donate sperm during the course of this study or for 12 weeks thereafter. 9. Participant has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-020, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias. 10. Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention \[example, cholecystectomy\]). 11. Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1. 12. Participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1). 13. The participant has poor peripheral venous access. 14. Participant has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1. 15. Vaccination with any live vaccine within 4 weeks of study drug administration. 16. Participant has a Screening or Check-in (Day -1) abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator medically qualified sub investigator. 17. Participant has QT interval with Fridericia correction method (QTcF) greater than (\>) 450 millisecond (msec) for men and women or PR outside the range of 120 to 220 msec confirmed upon repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1). 18. Participant has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.2\* the upper limit of normal (ULN). 2. Positive screen test for drugs of abuse. 3. Positive blood screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus-1 or -2 antibodies. 4. A positive test for tuberculosis (TB) (QuantiFERON).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | First dose of study drug up to and including 30 days after last dose of study drug (Up to 31 days) for Part 1 | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug. |
| Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | From Day 1 to Day 14 of Part 1 | Safety laboratory tests includes hematology, serum chemistries, and urinalysis. |
| Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | From Day 1 to Day 14 of Part 1 | Vital signs include oral temperature, respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse beats per minute (bpm). |
| Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | From Day 1 to Day 14 in Part 1 | A standard 12-lead ECG was performed. Change from baseline=CFB. |
| Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD) | First dose of study drug up to and including 30 days after last dose of study drug (Up to 39 days) in Part 2 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug. |
| Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | From Day 1 to Day 17 in Part 2 | Safety laboratory tests include hematology, and serum chemistries. |
| Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | From Day 1 to Day 17 in Part 2 | Vital signs include oral temperature respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse (bpm). |
| Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | From Day 1 to Day 17 in Part 2 | A standard 12-lead ECG was performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | — |
| AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | — |
| AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 in Part 2 | — |
| Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD) | Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
| Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD) | Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
| Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | — |
| Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
| Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | — |
| T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
| Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | — |
| Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | From pre-dose to 96 hours post-dose in Part 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
| Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | — |
| Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
| CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | CL/F was calculated as dose/AUC∞. |
| CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | CL/F was calculated as dose/AUCτ. |
| Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | Vz/F was calculated as (CL/F)/λz. |
| Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | Vz/F was calculated as (CL/F)/λz. |
| Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | — |
| Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2 | Ae(0-24) is calculated as calculated as Cur\*Vur, where Cu was the concentration of drug excreted in urine and Vur is the volume of urine excreted. |
| Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | — |
| Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1 | Fe was calculated as (Aet/dose)\*100. |
| Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2 | Fe was calculated as (Aet/dose)\*100. |
| Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | Fe was calculated as (Aet/dose)\*100. |
| Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | CLr was calculated as (Ae96/AUCt)\*100. |
| Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | CLr was calculated as (Ae24/AUC24)\*100. |
| R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (Up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
| Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1 | Ae(0-24) was calculated as calculated as Cur\*Vur, where Cur was the concentration of drug excreted in urine and Vur is the volume of urine excreted. |
| Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1 | — |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple time-points (up to 24 hours) post dose on Day 9 in Part 2 | — |
| AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1 | — |
| AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post dose on Day 9 in Part 2 | — |
| AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1 | — |
| AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Pre-dose and multiple timepoints (up to 24 Hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2 | — |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 1 investigative sites in the United States from 18 March 2015 to 04 May 2017.
Pre-assignment details
Healthy volunteers were enrolled to receive TAK-020 oral solution Single Rising Doses (SRD) \[0.1, 0.5, 2.5, 4.4, 8.8, 17.5, 35, 70, 105 milligrams (mgs)\] or placebo in Part 1 or Multiple Rising Doses (MRD) \[3.75, 5.75, 13, 25, 45, 60 mgs\] or Placebo in Part 2.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 Cohort 1-9: Placebo TAK-020 placebo-matching solution, orally, once on Day 1. | 18 |
| Part 1 Cohort 1: TAK-020 0.1 mg TAK-020 0.1 milligram (mg), solution, orally once on Day 1. | 6 |
| Part 1 Cohort 2: TAK-020 0.5 mg TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1. | 6 |
| Part 1 Cohort 3: TAK-020 2.5 mg TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2. | 6 |
| Part 1 Cohort 4: TAK-020 4.4 mg TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3. | 6 |
| Part 1 Cohort 5: TAK-020 8.8 mg TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4. | 6 |
| Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5. | 6 |
| Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6. | 6 |
| Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7. | 6 |
| Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8. | 6 |
| Part 2 Cohort 1-6: Placebo TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9. | 12 |
| Part 2 Cohort 1: TAK-020 3.75 mg TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study. | 6 |
| Part 2 Cohort 2: TAK-020 5.75 mg TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2. | 6 |
| Part 2 Cohort 3: TAK-020 13 mg TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2. | 6 |
| Part 2 Cohort 4: TAK-020 25 mg TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2. | 6 |
| Part 2 Cohort 5: TAK-020 45 mg TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2. | 6 |
| Part 2 Cohort 6: TAK-020 60 mg TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2. | 6 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Voluntary Withdrawal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1 Cohort 1: TAK-020 0.1 mg | Part 1 Cohort 2: TAK-020 0.5 mg | Part 1 Cohort 3: TAK-020 2.5 mg | Part 1 Cohort 4: TAK-020 4.4 mg | Part 1 Cohort 5: TAK-020 8.8 mg | Part 1 Cohort 6: TAK-020 17.5 mg | Part 1 Cohort 7: TAK-020 35 mg | Part 1 Cohort 8: TAK-020 70 mg | Part 1 Cohort 1-9: Placebo | Part 1 Cohort 9: TAK-020 105 mg | Part 2 Cohort 1-6: Placebo | Part 2 Cohort 1: TAK-020 3.75 mg | Part 2 Cohort 2: TAK-020 5.75 mg | Part 2 Cohort 3: TAK-020 13 mg | Part 2 Cohort 4: TAK-020 25 mg | Part 2 Cohort 6: TAK-020 60 mg | Part 2 Cohort 5: TAK-020 45 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 46.0 years STANDARD_DEVIATION 10.06 | 38.0 years STANDARD_DEVIATION 11.15 | 38.0 years STANDARD_DEVIATION 11.82 | 29.0 years STANDARD_DEVIATION 11.82 | 35.8 years STANDARD_DEVIATION 11.44 | 38.2 years STANDARD_DEVIATION 12.56 | 33.7 years STANDARD_DEVIATION 8.24 | 34.3 years STANDARD_DEVIATION 12.61 | 35.1 years STANDARD_DEVIATION 10.93 | 34.8 years STANDARD_DEVIATION 7.81 | 37.0 years STANDARD_DEVIATION 8.83 | 34.2 years STANDARD_DEVIATION 8.59 | 43.2 years STANDARD_DEVIATION 9.02 | 29.3 years STANDARD_DEVIATION 9.4 | 35.7 years STANDARD_DEVIATION 9.4 | 34.8 years STANDARD_DEVIATION 10.01 | 36.2 years STANDARD_DEVIATION 11.96 | 36.0 years STANDARD_DEVIATION 10.38 |
| Alcohol History Current drinker | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 2 Participants | 4 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 22 Participants |
| Alcohol History Ex- drinker | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Alcohol History Never drank | 5 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 3 Participants | 3 Participants | 4 Participants | 14 Participants | 6 Participants | 9 Participants | 4 Participants | 5 Participants | 6 Participants | 4 Participants | 6 Participants | 5 Participants | 96 Participants |
| Alcohol Participant Consumed | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 14 Participants |
| Body Mass Index (BMI) | 27.04 kg/m^2 STANDARD_DEVIATION 3.823 | 27.24 kg/m^2 STANDARD_DEVIATION 3.308 | 25.77 kg/m^2 STANDARD_DEVIATION 4.359 | 23.91 kg/m^2 STANDARD_DEVIATION 3.221 | 23.23 kg/m^2 STANDARD_DEVIATION 2.549 | 25.87 kg/m^2 STANDARD_DEVIATION 3.332 | 23.98 kg/m^2 STANDARD_DEVIATION 1.408 | 24.47 kg/m^2 STANDARD_DEVIATION 2.263 | 26.18 kg/m^2 STANDARD_DEVIATION 3.741 | 26.89 kg/m^2 STANDARD_DEVIATION 1.468 | 25.36 kg/m^2 STANDARD_DEVIATION 2.645 | 27.26 kg/m^2 STANDARD_DEVIATION 3.516 | 24.97 kg/m^2 STANDARD_DEVIATION 4.563 | 25.83 kg/m^2 STANDARD_DEVIATION 2.707 | 28.64 kg/m^2 STANDARD_DEVIATION 2.935 | 27.05 kg/m^2 STANDARD_DEVIATION 2.851 | 25.07 kg/m^2 STANDARD_DEVIATION 2.124 | 25.82 kg/m^2 STANDARD_DEVIATION 3.223 |
| Caffeine Consumption No | 3 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 4 Participants | 17 Participants | 6 Participants | 9 Participants | 4 Participants | 4 Participants | 6 Participants | 4 Participants | 5 Participants | 4 Participants | 97 Participants |
| Caffeine Consumption Yes | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 23 Participants |
| Female Reproductive Status Female of Childbearing Potential | 1 Participants | 0 Participants | 3 Participants | 5 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 9 Participants | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 29 Participants |
| Female Reproductive Status Not Applicable (Participant was Male) | 4 Participants | 6 Participants | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 7 Participants | 6 Participants | 7 Participants | 6 Participants | 3 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 80 Participants |
| Female Reproductive Status Postmenopausal | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 7 Participants |
| Female Reproductive Status Surgically Sterile | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 7 Participants | 1 Participants | 7 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 38 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 4 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 25 Participants |
| Race/Ethnicity, Customized Multiracial | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic and Latino | 6 Participants | 6 Participants | 6 Participants | 3 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 16 Participants | 4 Participants | 10 Participants | 5 Participants | 2 Participants | 3 Participants | 5 Participants | 6 Participants | 4 Participants | 95 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 5 Participants | 4 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 4 Participants | 8 Participants | 3 Participants | 5 Participants | 2 Participants | 5 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 67 Participants |
| Region of Enrollment United States | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 18 Participants | 6 Participants | 12 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 120 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 3 Participants | 5 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 11 Participants | 0 Participants | 5 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 40 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 7 Participants | 6 Participants | 7 Participants | 6 Participants | 3 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 80 Participants |
| Smoking History Ex-smoker | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 14 Participants |
| Smoking History Never Smoked | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 16 Participants | 5 Participants | 11 Participants | 6 Participants | 4 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 106 Participants |
| Xanthine Consumption No | 3 Participants | 5 Participants | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 4 Participants | 17 Participants | 6 Participants | 9 Participants | 4 Participants | 4 Participants | 6 Participants | 4 Participants | 5 Participants | 4 Participants | 99 Participants |
| Xanthine Consumption Yes | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 21 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 | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 2 / 18 | 0 / 6 | 0 / 6 | 1 / 6 | 0 / 6 | 1 / 6 | 0 / 6 | 0 / 6 | 3 / 6 | 1 / 6 | 5 / 12 | 1 / 6 | 3 / 6 | 3 / 6 | 2 / 6 | 1 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 18 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Time frame: First dose of study drug up to and including 30 days after last dose of study drug (Up to 31 days) for Part 1
Population: Safety Analysis Set was comprised of all participants who received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohort 1-9: Placebo | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 11.1 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 16.7 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 50 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) | 16.7 percentage of participants |
Primary
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Time frame: First dose of study drug up to and including 30 days after last dose of study drug (Up to 39 days) in Part 2
Population: Safety Analysis Set was comprised of all participants who received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohort 1-9: Placebo | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD) | 41.7 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD) | 16.7 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD) | 50.0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD) | 50.0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD) | 33.3 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD) | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD) | 16.7 percentage of participants |
Primary
Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD)
Safety laboratory tests includes hematology, serum chemistries, and urinalysis.
Time frame: From Day 1 to Day 14 of Part 1
Population: Safety Analysis Set was comprised of all participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 16.7 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 16.7 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 16.7 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 16.7 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 16.7 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Bilirubin Total >34.2 umol/L | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Triglycerides >2.5*ULN | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium >150 mmol/L | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Blood Urea Nitrogen (BUN) >10.7 mmol/L | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) | Sodium <130 mmol/L | 0 percentage of participants |
Primary
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD)
A standard 12-lead ECG was performed.
Time frame: From Day 1 to Day 17 in Part 2
Population: Safety Analysis Set included all participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) >=460 | 16.7 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) >=180 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (ms) ≥500/≥ 30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) <=80 | 16.7 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) <=80 | 50.0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) >=200 | 16.7 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) >=180 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) <=80 | 16.7 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) >=460 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (ms) ≥500/≥ 30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) >=200 | 16.7 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) <=80 | 33.3 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) >=180 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) <=80 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) >=200 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) <=80 | 50.0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) >=460 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (ms) ≥500/≥ 30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) <=80 | 16.7 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) <50 | 50.0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) <=80 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) >=200 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) >=460 | 16.7 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (ms) ≥500/≥ 30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) >=180 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) <50 | 50.0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) <=80 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) >=200 | 16.7 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (ms) ≥500/≥ 30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) <=80 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) >=460 | 33.3 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) >=180 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (ms) ≥500/≥ 30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) >=200 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) <=80 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) >=180 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) <=80 | 16.7 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) >=460 | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) >=200 | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcB Interval (ms) ≥500/≥ 30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) >=180 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QRS Interval (msec) <=80 | 50.0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | PR Interval (msec) <=80 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QT Interval (msec) >=460 | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | QTcF Interval (msec) <=300 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
Primary
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD)
A standard 12-lead ECG was performed. Change from baseline=CFB.
Time frame: From Day 1 to Day 14 in Part 1
Population: Safety Analysis Set was comprised of all participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 5.6 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 38.9 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 44.4 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 11.1 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 5.6 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 16.7 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 16.7 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 16.7 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 50.0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 16.7 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 66.7 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 33.3 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 83.3 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 16.7 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 16.7 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 16.7 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 16.7 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 33.3 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 83.3 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 16.7 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 50.0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 16.7 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 16.7 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 16.7 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 16.7 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 50.0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) <= 80 | 50.0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) >=460 | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) <50 | 33.3 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QT Interval (ms) <=300 | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) <= 300 | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (ms) >= 200 | 33.3 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QRS Interval (ms) >= 180 | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | Heart Rate (beats/min) >120 | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450 | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | QTcF Interval (ms) ≥500/≥30 CFB and >= 450 | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) | PR Interval (msec[ms]) <=80 | 0 percentage of participants |
Primary
Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD)
Safety laboratory tests include hematology, and serum chemistries.
Time frame: From Day 1 to Day 17 in Part 2
Population: Safety Analysis Set included all participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Lipase >3*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Creatine Kinase >5*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Creatine Kinase >5*ULN (U/L) | 16.7 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Lipase >3*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Lipase >3*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Creatine Kinase >5*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Creatine Kinase >5*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Lipase >3*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Creatine Kinase >5*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Lipase >3*ULN (U/L) | 16.7 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Hematology | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Lipase >3*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Creatine Kinase >5*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Lipase >3*ULN (U/L) | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Creatine Kinase >5*ULN (U/L) | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) | Hematology | 0 percentage of participants |
Primary
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD)
Vital signs include oral temperature, respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse beats per minute (bpm).
Time frame: From Day 1 to Day 14 of Part 1
Population: Safety Analysis Set was comprised of all participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 11.1 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 16.7 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 16.7 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 16.7 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 16.7 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 7: TAK-020 35 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 50 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 8: TAK-020 70 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature <35.6 C | 16.7 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 9: TAK-020 105 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) | Pulse <50 bpm | 0 percentage of participants |
Primary
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD)
Vital signs include oral temperature respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse (bpm).
Time frame: From Day 1 to Day 17 in Part 2
Population: Safety Analysis Set included all participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse <50 bpm | 8.3 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature <35.6 C | 33.3 percentage of participants |
| Part 1 Cohort 1-9: Placebo | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature <35.6 C | 16.7 percentage of participants |
| Part 1 Cohort 1: TAK-020 0.1 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse <50 bpm | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure <85 mm Hg | 16.7 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature <35.6 C | 33.3 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 2: TAK-020 0.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse <50 bpm | 16.7 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature <35.6 C | 33.3 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse <50 bpm | 0 percentage of participants |
| Part 1 Cohort 3: TAK-020 2.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature <35.6 C | 16.7 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse <50 bpm | 16.7 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 4: TAK-020 4.4 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature >37.7 C | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature <35.6 C | 16.7 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure <50 mm Hg | 16.7 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse <50 bpm | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse >120 bpm | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 5: TAK-020 8.8 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature <35.6 C | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure >110 mm Hg | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Body Temperature >37.7 C | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse <50 bpm | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Pulse >120 bpm | 16.7 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure <85 mm Hg | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Systolic Blood Pressure >180 mm Hg | 0 percentage of participants |
| Part 1 Cohort 6: TAK-020 17.5 mg | Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) | Diastolic Blood Pressure <50 mm Hg | 0 percentage of participants |
Secondary
Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD)
Ae(0-24) was calculated as calculated as Cur\*Vur, where Cur was the concentration of drug excreted in urine and Vur is the volume of urine excreted.
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | 0.002473 mg | Standard Deviation 0.0008033 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | 0.009898 mg | Standard Deviation 0.0049671 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | 0.069183 mg | Standard Deviation 0.0289653 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | 0.128195 mg | Standard Deviation 0.0412071 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | 0.227985 mg | Standard Deviation 0.0762743 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | 0.507260 mg | Standard Deviation 0.1109721 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | 0.963253 mg | Standard Deviation 0.3108451 |
| Part 1 Cohort 7: TAK-020 35 mg | Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | 2.010763 mg | Standard Deviation 0.3615714 |
| Part 1 Cohort 8: TAK-020 70 mg | Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD) | 1.925176 mg | Standard Deviation 0.626967 |
Secondary
Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD)
Ae(0-24) is calculated as calculated as Cur\*Vur, where Cu was the concentration of drug excreted in urine and Vur is the volume of urine excreted.
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 1 | 0.086153 mg | Standard Deviation 0.0362135 |
| Part 1 Cohort 1-9: Placebo | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 9 | 0.089955 mg | Standard Deviation 0.042354 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 1 | 0.149595 mg | Standard Deviation 0.0378613 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 9 | 0.181305 mg | Standard Deviation 0.0555997 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 1 | 0.418761 mg | Standard Deviation 0.1666534 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 9 | 0.385163 mg | Standard Deviation 0.1034764 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 1 | 1.095832 mg | Standard Deviation 0.4029873 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 9 | 1.004047 mg | Standard Deviation 0.2138181 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 1 | 1.186754 mg | Standard Deviation 0.3087747 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 9 | 1.370011 mg | Standard Deviation 0.3414174 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 1 | 1.569498 mg | Standard Deviation 0.354276 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) | Day 9 | 2.165337 mg | Standard Deviation 0.3525765 |
Secondary
Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | 0.002473 mg | Standard Deviation 0.0008033 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | 0.009999 mg | Standard Deviation 0.0049464 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | 0.069676 mg | Standard Deviation 0.0288376 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | 0.128604 mg | Standard Deviation 0.0411008 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | 0.229946 mg | Standard Deviation 0.0763608 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | 0.514036 mg | Standard Deviation 0.1144776 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | 0.977421 mg | Standard Deviation 0.3148372 |
| Part 1 Cohort 7: TAK-020 35 mg | Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | 2.062580 mg | Standard Deviation 0.3829068 |
| Part 1 Cohort 8: TAK-020 70 mg | Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD) | 1.988120 mg | Standard Deviation 0.6152605 |
Secondary
Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)
Vz/F was calculated as (CL/F)/λz.
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 118.3923 L | Standard Deviation 19.67518 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 292.2714 L | Standard Deviation 78.43782 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 290.5190 L | Standard Deviation 160.50093 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 281.7423 L | Standard Deviation 101.6461 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 655.4794 L | Standard Deviation 320.11459 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 416.8746 L | Standard Deviation 183.79449 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 807.4773 L | Standard Deviation 200.14983 |
| Part 1 Cohort 7: TAK-020 35 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 594.3399 L | Standard Deviation 149.97225 |
| Part 1 Cohort 8: TAK-020 70 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 1573.1600 L | Standard Deviation 901.24407 |
Secondary
Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD)
Vz/F was calculated as (CL/F)/λz.
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 442.5900 L | Standard Deviation 248.99792 |
| Part 1 Cohort 1-9: Placebo | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 366.8037 L | Standard Deviation 178.07012 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 329.6057 L | Standard Deviation 135.4703 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 266.5672 L | Standard Deviation 68.21454 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 632.4288 L | Standard Deviation 438.98268 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 565.3577 L | Standard Deviation 252.08686 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 460.7824 L | Standard Deviation 218.14865 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 352.4564 L | Standard Deviation 114.45822 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 698.3679 L | Standard Deviation 373.79793 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 530.4696 L | Standard Deviation 211.00235 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 715.0788 L | Standard Deviation 414.96986 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 503.3324 L | Standard Deviation 298.76176 |
Secondary
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | 0.7599 ng*hr/mL | Geometric Coefficient of Variation 45.6 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | 3.6691 ng*hr/mL | Geometric Coefficient of Variation 28.2 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | 29.7502 ng*hr/mL | Geometric Coefficient of Variation 48.1 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | 63.1772 ng*hr/mL | Geometric Coefficient of Variation 31.3 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | 98.8228 ng*hr/mL | Geometric Coefficient of Variation 34.6 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | 272.3381 ng*hr/mL | Geometric Coefficient of Variation 39.5 |
| Part 1 Cohort 6: TAK-020 17.5 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | 372.5881 ng*hr/mL | Geometric Coefficient of Variation 35.2 |
| Part 1 Cohort 7: TAK-020 35 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | 1009.0958 ng*hr/mL | Geometric Coefficient of Variation 32.3 |
| Part 1 Cohort 8: TAK-020 70 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD) | 875.0011 ng*hr/mL | Geometric Coefficient of Variation 15.9 |
p-value: 0.01990% CI: [1.0187, 1.1026]Power Model
Secondary
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 1 | 34.6177 ng*hr/mL | Geometric Coefficient of Variation 50.4 |
| Part 1 Cohort 1-9: Placebo | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 9 | 39.0653 ng*hr/mL | Geometric Coefficient of Variation 43.9 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 1 | 86.4177 ng*hr/mL | Geometric Coefficient of Variation 18.5 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 9 | 100.2960 ng*hr/mL | Geometric Coefficient of Variation 21.2 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 1 | 148.6319 ng*hr/mL | Geometric Coefficient of Variation 64.8 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 9 | 147.1828 ng*hr/mL | Geometric Coefficient of Variation 47.8 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 1 | 389.8000 ng*hr/mL | Geometric Coefficient of Variation 43 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 9 | 400.5548 ng*hr/mL | Geometric Coefficient of Variation 27.6 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 1 | 576.1987 ng*hr/mL | Geometric Coefficient of Variation 31.5 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 9 | 648.9853 ng*hr/mL | Geometric Coefficient of Variation 25.3 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 1 | 808.3223 ng*hr/mL | Geometric Coefficient of Variation 39.1 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) | Day 9 | 1011.2702 ng*hr/mL | Geometric Coefficient of Variation 44.9 |
Comparison: Day 1p-value: 0.25890% CI: [0.9628, 1.195]Power Model
Comparison: Day 9p-value: 0.14490% CI: [0.9878, 1.198]Power Model
Secondary
AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | 7.5994 ng*hr/mL/mg | Geometric Coefficient of Variation 45.6 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | 7.3382 ng*hr/mL/mg | Geometric Coefficient of Variation 28.2 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | 11.9001 ng*hr/mL/mg | Geometric Coefficient of Variation 48.1 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | 14.3584 ng*hr/mL/mg | Geometric Coefficient of Variation 31.3 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | 11.2299 ng*hr/mL/mg | Geometric Coefficient of Variation 34.6 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | 15.5622 ng*hr/mL/mg | Geometric Coefficient of Variation 39.5 |
| Part 1 Cohort 6: TAK-020 17.5 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | 10.6454 ng*hr/mL/mg | Geometric Coefficient of Variation 35.2 |
| Part 1 Cohort 7: TAK-020 35 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | 14.4157 ng*hr/mL/mg | Geometric Coefficient of Variation 32.3 |
| Part 1 Cohort 8: TAK-020 70 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD) | 8.3333 ng*hr/mL/mg | Geometric Coefficient of Variation 15.9 |
Secondary
AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 Hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 1 | 9.2314 ng*hr/mL/mg | Geometric Coefficient of Variation 50.4 |
| Part 1 Cohort 1-9: Placebo | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 9 | 10.4174 ng*hr/mL/mg | Geometric Coefficient of Variation 43.9 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 1 | 15.0292 ng*hr/mL/mg | Geometric Coefficient of Variation 18.5 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 9 | 17.4428 ng*hr/mL/mg | Geometric Coefficient of Variation 21.2 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 1 | 11.4332 ng*hr/mL/mg | Geometric Coefficient of Variation 64.8 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 9 | 11.3218 ng*hr/mL/mg | Geometric Coefficient of Variation 47.8 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 1 | 15.5920 ng*hr/mL/mg | Geometric Coefficient of Variation 43 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 9 | 16.0222 ng*hr/mL/mg | Geometric Coefficient of Variation 27.6 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 1 | 12.8044 ng*hr/mL/mg | Geometric Coefficient of Variation 31.5 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 9 | 14.4219 ng*hr/mL/mg | Geometric Coefficient of Variation 25.3 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 1 | 13.4720 ng*hr/mL/mg | Geometric Coefficient of Variation 39.1 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) | Day 9 | 16.8545 ng*hr/mL/mg | Geometric Coefficient of Variation 44.9 |
Secondary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 1.3733 ng*hr/mL | Geometric Coefficient of Variation 32.1 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 3.8341 ng*hr/mL | Geometric Coefficient of Variation 26.8 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 29.9808 ng*hr/mL | Geometric Coefficient of Variation 47.4 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 69.3298 ng*hr/mL | Geometric Coefficient of Variation 24.2 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 100.2928 ng*hr/mL | Geometric Coefficient of Variation 34.3 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 275.1708 ng*hr/mL | Geometric Coefficient of Variation 39.6 |
| Part 1 Cohort 6: TAK-020 17.5 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 380.2423 ng*hr/mL | Geometric Coefficient of Variation 35.2 |
| Part 1 Cohort 7: TAK-020 35 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 1030.7508 ng*hr/mL | Geometric Coefficient of Variation 32.3 |
| Part 1 Cohort 8: TAK-020 70 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD) | 907.7704 ng*hr/mL | Geometric Coefficient of Variation 14.5 |
p-value: 0.4990% CI: [0.9734, 1.0642]Power Model
Secondary
AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | 34.8469 ng*hr/mL | Geometric Coefficient of Variation 49.8 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | 86.7892 ng*hr/mL | Geometric Coefficient of Variation 18.1 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | 149.9419 ng*hr/mL | Geometric Coefficient of Variation 64.5 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | 393.8737 ng*hr/mL | Geometric Coefficient of Variation 43.2 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | 587.4204 ng*hr/mL | Geometric Coefficient of Variation 31.8 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) | 825.6238 ng*hr/mL | Geometric Coefficient of Variation 38.9 |
p-value: 0.22490% CI: [0.969, 1.2002]Power Model
Secondary
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD) | 34.1425 ng*hr/mL | Geometric Coefficient of Variation 50.2 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD) | 85.7708 ng*hr/mL | Geometric Coefficient of Variation 18.3 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD) | 148.6319 ng*hr/mL | Geometric Coefficient of Variation 64.8 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD) | 391.5478 ng*hr/mL | Geometric Coefficient of Variation 43.2 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD) | 583.7178 ng*hr/mL | Geometric Coefficient of Variation 32.2 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD) | 823.3525 ng*hr/mL | Geometric Coefficient of Variation 39 |
p-value: 0.20190% CI: [0.9735, 1.206]Power Model
Secondary
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | 0.6674 ng*hr/mL | Geometric Coefficient of Variation 50.3 |
| Part 1 Cohort 1: TAK-020 0.1 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | 3.5250 ng*hr/mL | Geometric Coefficient of Variation 30.3 |
| Part 1 Cohort 2: TAK-020 0.5 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | 29.4206 ng*hr/mL | Geometric Coefficient of Variation 48.1 |
| Part 1 Cohort 3: TAK-020 2.5 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | 62.4593 ng*hr/mL | Geometric Coefficient of Variation 31.9 |
| Part 1 Cohort 4: TAK-020 4.4 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | 98.6610 ng*hr/mL | Geometric Coefficient of Variation 34.4 |
| Part 1 Cohort 5: TAK-020 8.8 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | 273.0083 ng*hr/mL | Geometric Coefficient of Variation 40 |
| Part 1 Cohort 6: TAK-020 17.5 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | 378.3179 ng*hr/mL | Geometric Coefficient of Variation 35.5 |
| Part 1 Cohort 7: TAK-020 35 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | 1024.5599 ng*hr/mL | Geometric Coefficient of Variation 32.5 |
| Part 1 Cohort 8: TAK-020 70 mg | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD) | 903.9858 ng*hr/mL | Geometric Coefficient of Variation 14.6 |
p-value: 0.00390% CI: [1.0371, 1.1227]Power Model
Secondary
CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD)
CL/F was calculated as dose/AUC∞.
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | 74.6058 L/h | Standard Deviation 22.96089 |
| Part 1 Cohort 1: TAK-020 0.1 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | 134.3327 L/h | Standard Deviation 36.96594 |
| Part 1 Cohort 2: TAK-020 0.5 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | 90.8722 L/h | Standard Deviation 42.30328 |
| Part 1 Cohort 3: TAK-020 2.5 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | 64.9449 L/h | Standard Deviation 15.91608 |
| Part 1 Cohort 4: TAK-020 4.4 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | 92.1842 L/h | Standard Deviation 34.02451 |
| Part 1 Cohort 5: TAK-020 8.8 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | 67.4975 L/h | Standard Deviation 25.25161 |
| Part 1 Cohort 6: TAK-020 17.5 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | 96.6058 L/h | Standard Deviation 32.53095 |
| Part 1 Cohort 7: TAK-020 35 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | 70.7695 L/h | Standard Deviation 22.35098 |
| Part 1 Cohort 8: TAK-020 70 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD) | 116.6389 L/h | Standard Deviation 16.07341 |
Secondary
CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD)
CL/F was calculated as dose/AUCτ.
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 1 | 118.3171 L/h | Standard Deviation 58.62331 |
| Part 1 Cohort 1-9: Placebo | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 9 | 103.2882 L/h | Standard Deviation 42.85829 |
| Part 1 Cohort 1: TAK-020 0.1 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 1 | 67.1355 L/h | Standard Deviation 11.81065 |
| Part 1 Cohort 1: TAK-020 0.1 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 9 | 58.3884 L/h | Standard Deviation 12.20159 |
| Part 1 Cohort 2: TAK-020 0.5 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 1 | 100.6915 L/h | Standard Deviation 62.33954 |
| Part 1 Cohort 2: TAK-020 0.5 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 9 | 96.5521 L/h | Standard Deviation 46.88638 |
| Part 1 Cohort 3: TAK-020 2.5 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 1 | 68.2909 L/h | Standard Deviation 29.74598 |
| Part 1 Cohort 3: TAK-020 2.5 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 9 | 64.1696 L/h | Standard Deviation 16.00068 |
| Part 1 Cohort 4: TAK-020 4.4 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 1 | 79.5377 L/h | Standard Deviation 22.34558 |
| Part 1 Cohort 4: TAK-020 4.4 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 9 | 71.1027 L/h | Standard Deviation 16.99648 |
| Part 1 Cohort 5: TAK-020 8.8 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 1 | 76.9650 L/h | Standard Deviation 28.27771 |
| Part 1 Cohort 5: TAK-020 8.8 mg | CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) | Day 9 | 64.2873 L/h | Standard Deviation 29.63651 |
Secondary
Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 1 | 4.3778 ng/mL/mg | Geometric Coefficient of Variation 46.7 |
| Part 1 Cohort 1-9: Placebo | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 9 | 4.7194 ng/mL/mg | Geometric Coefficient of Variation 34.2 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 1 | 7.0123 ng/mL/mg | Geometric Coefficient of Variation 14.4 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 9 | 6.8928 ng/mL/mg | Geometric Coefficient of Variation 17.7 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 1 | 4.9815 ng/mL/mg | Geometric Coefficient of Variation 73.3 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 9 | 4.8972 ng/mL/mg | Geometric Coefficient of Variation 34.5 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 1 | 6.4761 ng/mL/mg | Geometric Coefficient of Variation 47.1 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 9 | 6.4278 ng/mL/mg | Geometric Coefficient of Variation 33 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 1 | 6.6860 ng/mL/mg | Geometric Coefficient of Variation 33.3 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 9 | 6.2139 ng/mL/mg | Geometric Coefficient of Variation 34.1 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 1 | 7.0636 ng/mL/mg | Geometric Coefficient of Variation 46.9 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) | Day 9 | 7.2237 ng/mL/mg | Geometric Coefficient of Variation 43.7 |
Secondary
Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | 4.6312 ng/mL/mg | Geometric Coefficient of Variation 36.3 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | 3.1058 ng/mL/mg | Geometric Coefficient of Variation 25.2 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | 5.4190 ng/mL/mg | Geometric Coefficient of Variation 40.7 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | 5.5003 ng/mL/mg | Geometric Coefficient of Variation 29.5 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | 4.8674 ng/mL/mg | Geometric Coefficient of Variation 43.3 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | 6.0440 ng/mL/mg | Geometric Coefficient of Variation 33.3 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | 4.4473 ng/mL/mg | Geometric Coefficient of Variation 31.8 |
| Part 1 Cohort 7: TAK-020 35 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | 6.3742 ng/mL/mg | Geometric Coefficient of Variation 50.9 |
| Part 1 Cohort 8: TAK-020 70 mg | Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD) | 3.2901 ng/mL/mg | Geometric Coefficient of Variation 51.6 |
Secondary
Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | 0.4631 ng/mL | Geometric Coefficient of Variation 36.3 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | 1.5529 ng/mL | Geometric Coefficient of Variation 25.2 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | 13.5475 ng/mL | Geometric Coefficient of Variation 40.7 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | 24.2013 ng/mL | Geometric Coefficient of Variation 29.5 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | 42.8329 ng/mL | Geometric Coefficient of Variation 43.3 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | 105.7708 ng/mL | Geometric Coefficient of Variation 33.3 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | 155.6549 ng/mL | Geometric Coefficient of Variation 31.8 |
| Part 1 Cohort 7: TAK-020 35 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | 446.1922 ng/mL | Geometric Coefficient of Variation 50.9 |
| Part 1 Cohort 8: TAK-020 70 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD) | 345.4612 ng/mL | Geometric Coefficient of Variation 51.6 |
p-value: 0.46590% CI: [0.9752, 1.0637]Power Model
Secondary
Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 16.4167 ng/mL | Geometric Coefficient of Variation 46.7 |
| Part 1 Cohort 1-9: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 17.6976 ng/mL | Geometric Coefficient of Variation 34.2 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 40.3204 ng/mL | Geometric Coefficient of Variation 14.4 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 39.6336 ng/mL | Geometric Coefficient of Variation 17.7 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 64.7590 ng/mL | Geometric Coefficient of Variation 73.3 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 63.6636 ng/mL | Geometric Coefficient of Variation 34.5 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 161.9015 ng/mL | Geometric Coefficient of Variation 47.1 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 160.6945 ng/mL | Geometric Coefficient of Variation 33 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 300.8684 ng/mL | Geometric Coefficient of Variation 33.3 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 279.6237 ng/mL | Geometric Coefficient of Variation 34.1 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 1 | 423.8189 ng/mL | Geometric Coefficient of Variation 46.9 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) | Day 9 | 433.4214 ng/mL | Geometric Coefficient of Variation 43.7 |
Comparison: Day 1p-value: 0.12690% CI: [0.9913, 1.2336]Power Model
Comparison: Day 9p-value: 0.11490% CI: [0.9962, 1.1838]Power Model
Secondary
Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)
Fe was calculated as (Aet/dose)\*100.
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.4733 percentage of TAK-020 dose | Standard Deviation 0.80334 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 1.9796 percentage of TAK-020 dose | Standard Deviation 0.99341 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.7673 percentage of TAK-020 dose | Standard Deviation 1.15861 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.9135 percentage of TAK-020 dose | Standard Deviation 0.93653 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.5907 percentage of TAK-020 dose | Standard Deviation 0.86675 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.8986 percentage of TAK-020 dose | Standard Deviation 0.63413 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.7522 percentage of TAK-020 dose | Standard Deviation 0.88813 |
| Part 1 Cohort 7: TAK-020 35 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.8725 percentage of TAK-020 dose | Standard Deviation 0.51653 |
| Part 1 Cohort 8: TAK-020 70 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 1.8335 percentage of TAK-020 dose | Standard Deviation 0.59711 |
Secondary
Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD)
Fe was calculated as (Aet/dose)\*100.
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 1 | 2.2974 percentage of TAK-020 dose | Standard Deviation 0.96569 |
| Part 1 Cohort 1-9: Placebo | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 9 | 2.3988 percentage of TAK-020 dose | Standard Deviation 1.12944 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 1 | 2.6016 percentage of TAK-020 dose | Standard Deviation 0.65846 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 9 | 3.1531 percentage of TAK-020 dose | Standard Deviation 0.96695 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 1 | 3.2212 percentage of TAK-020 dose | Standard Deviation 1.28195 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 9 | 2.9628 percentage of TAK-020 dose | Standard Deviation 0.79597 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 1 | 4.3833 percentage of TAK-020 dose | Standard Deviation 1.61195 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 9 | 4.0162 percentage of TAK-020 dose | Standard Deviation 0.85527 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 1 | 2.6372 percentage of TAK-020 dose | Standard Deviation 0.68617 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 9 | 3.0445 percentage of TAK-020 dose | Standard Deviation 0.75871 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 1 | 2.6158 percentage of TAK-020 dose | Standard Deviation 0.59046 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) | Day 9 | 3.6089 percentage of TAK-020 dose | Standard Deviation 0.58763 |
Secondary
Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)
Fe was calculated as (Aet/dose)\*100.
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.4733 percentage of TAK-020 dose | Standard Deviation 0.80334 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 1.9999 percentage of TAK-020 dose | Standard Deviation 0.98928 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.7870 percentage of TAK-020 dose | Standard Deviation 1.15351 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.9228 percentage of TAK-020 dose | Standard Deviation 0.93411 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.6130 percentage of TAK-020 dose | Standard Deviation 0.86774 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.9373 percentage of TAK-020 dose | Standard Deviation 0.65416 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.7926 percentage of TAK-020 dose | Standard Deviation 0.89953 |
| Part 1 Cohort 7: TAK-020 35 mg | Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 2.9465 percentage of TAK-020 dose | Standard Deviation 0.54701 |
| Part 1 Cohort 8: TAK-020 70 mg | Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD) | 1.8934 percentage of TAK-020 dose | Standard Deviation 0.58596 |
Secondary
Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | 0.6226 1/hr | Standard Deviation 0.09046 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | 0.4659 1/hr | Standard Deviation 0.08893 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | 0.3223 1/hr | Standard Deviation 0.05573 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | 0.2402 1/hr | Standard Deviation 0.05603 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | 0.1496 1/hr | Standard Deviation 0.03468 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | 0.1745 1/hr | Standard Deviation 0.05957 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | 0.1202 1/hr | Standard Deviation 0.02831 |
| Part 1 Cohort 7: TAK-020 35 mg | Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | 0.1216 1/hr | Standard Deviation 0.03677 |
| Part 1 Cohort 8: TAK-020 70 mg | Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD) | 0.1004 1/hr | Standard Deviation 0.06068 |
p-value: <0.0001ANOVA
Secondary
Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD)
Time frame: From pre-dose to 96 hours post-dose in Part 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 1 | 0.2732 1/hr | Standard Deviation 0.0455 |
| Part 1 Cohort 1-9: Placebo | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 9 | 0.3325 1/hr | Standard Deviation 0.07185 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 1 | 0.2231 1/hr | Standard Deviation 0.06562 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 9 | 0.2264 1/hr | Standard Deviation 0.05325 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 1 | 0.1667 1/hr | Standard Deviation 0.01608 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 9 | 0.1699 1/hr | Standard Deviation 0.02117 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 1 | 0.1655 1/hr | Standard Deviation 0.05994 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 9 | 0.1880 1/hr | Standard Deviation 0.03581 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 1 | 0.1263 1/hr | Standard Deviation 0.03599 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 9 | 0.1471 1/hr | Standard Deviation 0.04752 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 1 | 0.1216 1/hr | Standard Deviation 0.0488 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) | Day 9 | 0.1363 1/hr | Standard Deviation 0.0431 |
Secondary
Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD) | 1.1285 ratio | Geometric Coefficient of Variation 21.9 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD) | 1.1606 ratio | Geometric Coefficient of Variation 8.9 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD) | 0.9903 ratio | Geometric Coefficient of Variation 18.7 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD) | 1.0628 ratio | Geometric Coefficient of Variation 23.3 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD) | 1.1263 ratio | Geometric Coefficient of Variation 10.7 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD) | 1.2511 ratio | Geometric Coefficient of Variation 15.6 |
Secondary
Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD) | 1.0780 ratio | Geometric Coefficient of Variation 22.9 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD) | 0.9830 ratio | Geometric Coefficient of Variation 10.5 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD) | 0.9831 ratio | Geometric Coefficient of Variation 39.4 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD) | 0.9379 ratio | Geometric Coefficient of Variation 29.2 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD) | 0.9294 ratio | Geometric Coefficient of Variation 16.3 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD) | 1.0227 ratio | Geometric Coefficient of Variation 29.5 |
Secondary
Renal Clearance (CLr) for TAK-020 in Part 1 (SRD)
CLr was calculated as (Ae96/AUCt)\*100.
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | 3.6856 L/h | Standard Deviation 1.20477 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | 2.6010 L/h | Standard Deviation 0.62075 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | 2.5250 L/h | Standard Deviation 1.30987 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | 2.0190 L/h | Standard Deviation 0.47688 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | 2.2159 L/h | Standard Deviation 0.15331 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | 1.8896 L/h | Standard Deviation 0.60426 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | 2.6108 L/h | Standard Deviation 1.03807 |
| Part 1 Cohort 7: TAK-020 35 mg | Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | 2.0007 L/h | Standard Deviation 0.28823 |
| Part 1 Cohort 8: TAK-020 70 mg | Renal Clearance (CLr) for TAK-020 in Part 1 (SRD) | 2.1898 L/h | Standard Deviation 0.63728 |
Secondary
Renal Clearance (CLr) for TAK-020 in Part 2 (MRD)
CLr was calculated as (Ae24/AUC24)\*100.
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 1 | 2.3165 L/h | Standard Deviation 0.35669 |
| Part 1 Cohort 1-9: Placebo | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 9 | 2.0802 L/h | Standard Deviation 0.3676 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 1 | 1.7168 L/h | Standard Deviation 0.42806 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 9 | 1.7732 L/h | Standard Deviation 0.41318 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 1 | 2.8969 L/h | Standard Deviation 1.50559 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 9 | 2.6754 L/h | Standard Deviation 1.08869 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 1 | 2.6497 L/h | Standard Deviation 0.42235 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 9 | 2.5311 L/h | Standard Deviation 0.65737 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 1 | 2.1525 L/h | Standard Deviation 0.83694 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 9 | 2.2053 L/h | Standard Deviation 0.80067 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 1 | 1.9597 L/h | Standard Deviation 0.52835 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) | Day 9 | 2.2405 L/h | Standard Deviation 0.82268 |
Secondary
R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (Up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 1 | 3.551 ratio | Standard Error 0.1578 |
| Part 1 Cohort 1-9: Placebo | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 9 | 3.665 ratio | Standard Error 0.1578 |
| Part 1 Cohort 1: TAK-020 0.1 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 1 | 4.463 ratio | Standard Error 0.1578 |
| Part 1 Cohort 1: TAK-020 0.1 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 9 | 4.608 ratio | Standard Error 0.1578 |
| Part 1 Cohort 2: TAK-020 0.5 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 1 | 5.010 ratio | Standard Error 0.1578 |
| Part 1 Cohort 2: TAK-020 0.5 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 9 | 4.992 ratio | Standard Error 0.1578 |
| Part 1 Cohort 3: TAK-020 2.5 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 1 | 5.940 ratio | Standard Error 0.1728 |
| Part 1 Cohort 3: TAK-020 2.5 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 9 | 5.993 ratio | Standard Error 0.1728 |
| Part 1 Cohort 4: TAK-020 4.4 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 1 | 6.376 ratio | Standard Error 0.1578 |
| Part 1 Cohort 4: TAK-020 4.4 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 9 | 6.475 ratio | Standard Error 0.1578 |
| Part 1 Cohort 5: TAK-020 8.8 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 1 | 6.716 ratio | Standard Error 0.1578 |
| Part 1 Cohort 5: TAK-020 8.8 mg | R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) | Day 9 | 6.919 ratio | Standard Error 0.1578 |
90% CI: [0.772, 1.628]
90% CI: [0.796, 1.678]
90% CI: [0.676, 1.425]
90% CI: [0.701, 1.587]
90% CI: [0.761, 1.604]
90% CI: [0.844, 1.778]
Secondary
T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 1 | 2.5948 hr | Standard Deviation 0.42162 |
| Part 1 Cohort 1-9: Placebo | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 9 | 2.1537 hr | Standard Deviation 0.42833 |
| Part 1 Cohort 1: TAK-020 0.1 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 1 | 3.3397 hr | Standard Deviation 0.96341 |
| Part 1 Cohort 1: TAK-020 0.1 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 9 | 3.2089 hr | Standard Deviation 0.77467 |
| Part 1 Cohort 2: TAK-020 0.5 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 1 | 4.1895 hr | Standard Deviation 0.40518 |
| Part 1 Cohort 2: TAK-020 0.5 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 9 | 4.1335 hr | Standard Deviation 0.51741 |
| Part 1 Cohort 3: TAK-020 2.5 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 1 | 4.8507 hr | Standard Deviation 2.21078 |
| Part 1 Cohort 3: TAK-020 2.5 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 9 | 3.7934 hr | Standard Deviation 0.70657 |
| Part 1 Cohort 4: TAK-020 4.4 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 1 | 6.0124 hr | Standard Deviation 2.30297 |
| Part 1 Cohort 4: TAK-020 4.4 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 9 | 5.1273 hr | Standard Deviation 1.58301 |
| Part 1 Cohort 5: TAK-020 8.8 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 1 | 6.2971 hr | Standard Deviation 1.82711 |
| Part 1 Cohort 5: TAK-020 8.8 mg | T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) | Day 9 | 5.4635 hr | Standard Deviation 1.47268 |
Secondary
Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | 1.1251 hr | Standard Deviation 0.16347 |
| Part 1 Cohort 1: TAK-020 0.1 mg | Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | 1.5323 hr | Standard Deviation 0.28359 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | 2.2093 hr | Standard Deviation 0.41162 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | 3.0159 hr | Standard Deviation 0.70963 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | 4.8384 hr | Standard Deviation 1.06916 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | 4.2946 hr | Standard Deviation 1.18227 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | 6.0601 hr | Standard Deviation 1.55255 |
| Part 1 Cohort 7: TAK-020 35 mg | Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | 6.1098 hr | Standard Deviation 1.65014 |
| Part 1 Cohort 8: TAK-020 70 mg | Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD) | 9.0275 hr | Standard Deviation 4.78526 |
Secondary
Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 1 | 0.0000 hr |
| Part 1 Cohort 1-9: Placebo | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 9 | 0.0000 hr |
| Part 1 Cohort 1: TAK-020 0.1 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 1 | 0.0000 hr |
| Part 1 Cohort 1: TAK-020 0.1 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 9 | 0.0000 hr |
| Part 1 Cohort 2: TAK-020 0.5 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 1 | 0.0000 hr |
| Part 1 Cohort 2: TAK-020 0.5 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 9 | 0.0000 hr |
| Part 1 Cohort 3: TAK-020 2.5 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 1 | 0.0000 hr |
| Part 1 Cohort 3: TAK-020 2.5 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 9 | 0.0000 hr |
| Part 1 Cohort 4: TAK-020 4.4 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 1 | 0.0000 hr |
| Part 1 Cohort 4: TAK-020 4.4 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 9 | 0.0000 hr |
| Part 1 Cohort 5: TAK-020 8.8 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 1 | 0.0000 hr |
| Part 1 Cohort 5: TAK-020 8.8 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) | Day 9 | 0.0000 hr |
Secondary
Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 Cohort 1-9: Placebo | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | 0.0000 hr |
| Part 1 Cohort 1: TAK-020 0.1 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | 0.0000 hr |
| Part 1 Cohort 2: TAK-020 0.5 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | 0.0000 hr |
| Part 1 Cohort 3: TAK-020 2.5 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | 0.0000 hr |
| Part 1 Cohort 4: TAK-020 4.4 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | 0.0000 hr |
| Part 1 Cohort 5: TAK-020 8.8 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | 0.0000 hr |
| Part 1 Cohort 6: TAK-020 17.5 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | 0.0000 hr |
| Part 1 Cohort 7: TAK-020 35 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | 0.0000 hr |
| Part 1 Cohort 8: TAK-020 70 mg | Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD) | 0.0000 hr |
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 Cohort 1-9: Placebo | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | 0.750 hr |
| Part 1 Cohort 1: TAK-020 0.1 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | 0.700 hr |
| Part 1 Cohort 2: TAK-020 0.5 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | 0.745 hr |
| Part 1 Cohort 3: TAK-020 2.5 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | 0.825 hr |
| Part 1 Cohort 4: TAK-020 4.4 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | 0.780 hr |
| Part 1 Cohort 5: TAK-020 8.8 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | 1.010 hr |
| Part 1 Cohort 6: TAK-020 17.5 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | 0.630 hr |
| Part 1 Cohort 7: TAK-020 35 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | 0.725 hr |
| Part 1 Cohort 8: TAK-020 70 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD) | 0.750 hr |
p-value: 0.5402ANOVA
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple time-points (up to 24 hours) post dose on Day 9 in Part 2
Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1 Cohort 1-9: Placebo | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 1 | 0.750 hr |
| Part 1 Cohort 1-9: Placebo | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 9 | 0.750 hr |
| Part 1 Cohort 1: TAK-020 0.1 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 1 | 0.750 hr |
| Part 1 Cohort 1: TAK-020 0.1 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 9 | 1.000 hr |
| Part 1 Cohort 2: TAK-020 0.5 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 1 | 0.750 hr |
| Part 1 Cohort 2: TAK-020 0.5 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 9 | 0.750 hr |
| Part 1 Cohort 3: TAK-020 2.5 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 1 | 0.750 hr |
| Part 1 Cohort 3: TAK-020 2.5 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 9 | 0.750 hr |
| Part 1 Cohort 4: TAK-020 4.4 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 1 | 0.500 hr |
| Part 1 Cohort 4: TAK-020 4.4 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 9 | 0.750 hr |
| Part 1 Cohort 5: TAK-020 8.8 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 1 | 0.640 hr |
| Part 1 Cohort 5: TAK-020 8.8 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) | Day 9 | 0.875 hr |
Comparison: Day 1p-value: 0.7824ANOVA
Comparison: Day 9p-value: 0.4056ANOVA