Healthy
Conditions
Brief summary
The purpose of this study is to assess the relative bioavailability of solid oral formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation and to evaluate the food effect and potentially the dose proportionality of the optimal oral solid formulation.
Detailed description
TAK-020 is being developed for the potential treatment of autoimmune diseases including rheumatoid arthritis. Currently TAK-020 is available as an oral solution. This study is to develop an oral tablet formulation. There are three parts to this study. Part 1 will compare different tablet formulations of TAK-020 compared to a reference oral solution to identify the best tablet formulation to use in Parts 2 and 3. Part 2 will look at the effect food has on TAK-020. Part 3 is optional; its implementation will be decided upon using data from Part 2. It will evaluate whether increased doses of TAK-020 produce an expected proportional increase in the plasma concentration of TAK-020. In Part 1 participants will receive a single dose of the following: Period 1: TAK-020 Oral Solution Period 2: TAK-020 Co-Crystal Tablet Period 3: TAK-020 Solid Dispersion Tablet Period 4: TAK-020 Immediate Release Tablet In Part 2 participants will be split into two groups; one will receive the chosen formulation of TAK-020 in the fasted state followed by the fed state and the other group will receive it in the fed state followed by the fasted state. The dose used in Part 2 will be based upon data from Part 1 and previous studies. Participants in Part 3 of the study will be split into 2 cohorts. Each cohort will be administered, in the fasted state, a single dose of the tablet selected as optimal from previous study parts. The dose used will be based upon data from Parts 1 and 2 and previous studies. Part 1 will assess the relative bioavailability of TAK-020 by using analysis of variance (ANOVA) on tmax, and the natural logarithms of AUCs, and Cmax. Part 2 will assess the food effect of TAK-020, also using ANOVA on tmax, and the natural logarithms of AUCs, and Cmax. The power model will be used to assess dose proportionality of single doses of the solid formulations in the fasted state from Parts 2 and 3.
Interventions
DRUGTAK-020 Captisol Oral Solution
TAK-020 solution.
DRUGTAK-020 CCT
TAK-020 co-crystal tablet
DRUGTAK-020 SDT
TAK-020 Solid dispersion tablet.
DRUGTAK-020 IRT
TAK-020 immediate release tablet.
DRUGTAK-020 Solid Formulation
TAK-020 solid formulation
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is capable of understanding and complying with protocol requirements. 2. Is 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. Is a healthy adult male or female. 4. Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose. 5. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m\^2), inclusive at Screening and Day -1. 6. 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 90 days after last dose of study medication. 7. Female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study and until the next menstrual period or 90 days after exit from the study, whichever is first. If the next menstrual period is delayed, a pregnancy test will be required for exclusion of pregnancy.
Exclusion criteria
1. Has received any investigational compound within 30 days prior to Screening. 2. Is an immediate family member, study site employee, or is 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. Has a known hypersensitivity to any component of the formulation of TAK-020, Captisol, or related compounds. 4. Has a positive urine drug result for drugs of abuse or a positive breath alcohol screen at Screening or Check-in (Day -1). 5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as 4 or more alcoholic units per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. 6. Has taken any excluded medication, supplements, or food products listed in Prohibited Medications and Foods table. 7. If female, is pregnant or lactating or intending to become pregnant before, during or within 3 months after exit from this study (90 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 90 days after the last dose of study drug. 9. 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. 10. 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. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1. 12. 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. Has poor peripheral venous access. 14. Has donated or lost 450 mililiter (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. 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 or medically qualified subinvestigator. 16. Has QT interval with Fridericia correction method (QTcF) greater than (\>) 430 millisecond (msec) for men and \>450 msec for 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). 17. 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) and/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 (test done at Screening visit only). 4. A positive test for tuberculosis (TB) (QuantiFERON) (test done at Screening Visit only). 18. Vaccination with any live vaccine within 4 weeks of study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020 | Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose |
| Cmax: Maximum Observed Plasma Concentration for TAK-020 | Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 | Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020 | Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE) | Baseline up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2) |
| Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Baseline up to Day 2 |
| Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Baseline up to Day 2 |
| Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | Baseline up to Day 2 |
Countries
United Kingdom
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the United Kingdom from 28 April 2016 to 24 August 2016.
Pre-assignment details
Healthy participants were enrolled in 3 part study to receive TAK-020. Part-1: relative bio-availability of solid formulations, Part-2: effect of food on co-crystal tablet(CCT) and Part-3: dose linearity of CCT. Part-3 was not conducted, as relative bioavailability of solid formulation was greater than(\>) 50% compared with oral solution of TAK-020.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: TAK-020 17.5 mg TAK-020 17.5 mg, OS, under fasted state, once on Day 1 of first intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, SDT, orally, under fasted state, once on Day 1 of third intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, IRT, orally, under fasted state, once on Day 1 of fourth intervention period. | 11 |
| Part 2- TAK-020 25 mg CCT: Fasted + Fed TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fed, once on Day 1 of second intervention period. | 7 |
| Part 2- TAK-020 25 mg CCT: Fed + Fasted TAK-020 25 mg, CCT, orally, under fed state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period. | 7 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Second Intervention Period | Adverse Event | 1 | 0 | 0 |
| Second Intervention Period | Protocol Violation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part 2- TAK-020 25 mg CCT: Fed + Fasted | Part 2- TAK-020 25 mg CCT: Fasted + Fed | Part 1: TAK-020 17.5 mg |
|---|---|---|---|---|
| Age, Continuous | 39.3 years STANDARD_DEVIATION 10.68 | 38.9 years STANDARD_DEVIATION 12.36 | 31.1 years STANDARD_DEVIATION 6.49 | 44.7 years STANDARD_DEVIATION 8.82 |
| Alcohol Classification Current drinker | 22 Participants | 6 Participants | 6 Participants | 10 Participants |
| Alcohol Classification Ex-drinker | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Alcohol Classification Never drinks | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Amount of Alcohol Consumed by Participant 4 or more drinks per day | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Amount of Alcohol Consumed by Participant Less than (<) 4 drinks per day | 22 Participants | 6 Participants | 6 Participants | 10 Participants |
| Body Mass Index (BMI) | 25.57 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.9 | 25.19 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.884 | 24.91 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.724 | 26.23 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.14 |
| Caffeine/Xanthine Classification Caffeine/xanthine consumption | 24 Participants | 7 Participants | 7 Participants | 10 Participants |
| Caffeine/Xanthine Classification No caffeine/xanthine consumption | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 7 Participants | 7 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Female Reproductive Status Female of childbearing potential | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Female Reproductive Status Not applicable (male participants) | 17 Participants | 6 Participants | 4 Participants | 7 Participants |
| Female Reproductive Status Surgically sterile | 4 Participants | 0 Participants | 1 Participants | 3 Participants |
| Height | 172.2 centimeter (cm) STANDARD_DEVIATION 8.34 | 173.0 centimeter (cm) STANDARD_DEVIATION 6.51 | 172.3 centimeter (cm) STANDARD_DEVIATION 7.36 | 171.7 centimeter (cm) STANDARD_DEVIATION 10.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 7 Participants | 7 Participants | 10 Participants |
| Region of Enrollment United Kingdom | 25 Participants | 7 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Female | 8 Participants | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 17 Participants | 6 Participants | 4 Participants | 7 Participants |
| Smoking Classification Current smoker | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoking Classification Ex-smoker | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Smoking Classification Never smoked | 21 Participants | 5 Participants | 6 Participants | 10 Participants |
| Weight | 76.32 kilogram (kg) STANDARD_DEVIATION 13.212 | 75.50 kilogram (kg) STANDARD_DEVIATION 10.207 | 74.26 kilogram (kg) STANDARD_DEVIATION 11.454 | 78.16 kilogram (kg) STANDARD_DEVIATION 16.448 |
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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 11 | 3 / 11 | 0 / 9 | 0 / 9 | 1 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 9 | 0 / 9 | 0 / 14 | 0 / 14 |
Outcome results
Primary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Population: The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: TAK-020 17.5 mg OS | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020 | 257.455 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 97.5416 |
| Part 1: TAK-020 17.5 mg CCT | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020 | 164.485 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 72.4927 |
| Part 1: TAK-020 17.5 mg SDT | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020 | 316.448 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 127.4409 |
| Part 1: TAK-020 17.5 mg IRT | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020 | 32.783 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 18.5993 |
| Part 2: TAK-020 25 mg CCT Fasted | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020 | 220.396 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 89.7255 |
| Part 2: TAK-020 25 mg CCT Fed | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020 | 185.935 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 29.6651 |
Comparison: ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.p-value: 0.00790% CI: [0.497, 0.844]ANOVA
Comparison: ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.p-value: 0.42390% CI: [1.088, 1.279]ANOVA
Comparison: ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.p-value: <0.00190% CI: [0.077, 0.176]ANOVA
Comparison: ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.p-value: 0.03790% CI: [0.731, 0.957]ANOVA
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Population: The pharmacokinetic (PK) set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: TAK-020 17.5 mg OS | Cmax: Maximum Observed Plasma Concentration for TAK-020 | 104.182 nanogram per milliliter (ng/mL) | Standard Deviation 35.0658 |
| Part 1: TAK-020 17.5 mg CCT | Cmax: Maximum Observed Plasma Concentration for TAK-020 | 44.800 nanogram per milliliter (ng/mL) | Standard Deviation 26.4189 |
| Part 1: TAK-020 17.5 mg SDT | Cmax: Maximum Observed Plasma Concentration for TAK-020 | 139.522 nanogram per milliliter (ng/mL) | Standard Deviation 71.6739 |
| Part 1: TAK-020 17.5 mg IRT | Cmax: Maximum Observed Plasma Concentration for TAK-020 | 6.012 nanogram per milliliter (ng/mL) | Standard Deviation 1.8606 |
| Part 2: TAK-020 25 mg CCT Fasted | Cmax: Maximum Observed Plasma Concentration for TAK-020 | 63.314 nanogram per milliliter (ng/mL) | Standard Deviation 34.1699 |
| Part 2: TAK-020 25 mg CCT Fed | Cmax: Maximum Observed Plasma Concentration for TAK-020 | 40.629 nanogram per milliliter (ng/mL) | Standard Deviation 17.675 |
Comparison: Analysis of variance (ANOVA) was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90 percent (%) confidence interval (CI) was obtained by taking the antilog of the difference in the log transformed least square (LS) means and its CI, respectively.p-value: <0.00190% CI: [0.32, 0.505]ANOVA
Comparison: ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.p-value: 0.24990% CI: [1.016, 1.455]ANOVA
Comparison: ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.p-value: <0.00190% CI: [0.041, 0.074]ANOVA
Comparison: ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.p-value: 0.05490% CI: [0.499, 0.939]ANOVA
Primary
Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Population: The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: TAK-020 17.5 mg OS | Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020 | 4.695 hour | Standard Deviation 1.0781 |
| Part 1: TAK-020 17.5 mg CCT | Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020 | 4.661 hour | Standard Deviation 1.4147 |
| Part 1: TAK-020 17.5 mg SDT | Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020 | 3.976 hour | Standard Deviation 0.9787 |
| Part 1: TAK-020 17.5 mg IRT | Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020 | 5.005 hour | Standard Deviation 2.8545 |
| Part 2: TAK-020 25 mg CCT Fasted | Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020 | 6.183 hour | Standard Deviation 0.8914 |
| Part 2: TAK-020 25 mg CCT Fed | Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020 | 4.412 hour | Standard Deviation 1.2323 |
Primary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Population: The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: TAK-020 17.5 mg OS | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 | 0.530 hour |
| Part 1: TAK-020 17.5 mg CCT | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 | 1.000 hour |
| Part 1: TAK-020 17.5 mg SDT | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 | 0.750 hour |
| Part 1: TAK-020 17.5 mg IRT | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 | 1.000 hour |
| Part 2: TAK-020 25 mg CCT Fasted | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 | 1.000 hour |
| Part 2: TAK-020 25 mg CCT Fed | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 | 2.000 hour |
Secondary
Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
Population: The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: TAK-020 17.5 mg OS | Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE) | 1 participants |
| Part 1: TAK-020 17.5 mg CCT | Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE) | 3 participants |
| Part 1: TAK-020 17.5 mg SDT | Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE) | 0 participants |
| Part 1: TAK-020 17.5 mg IRT | Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE) | 0 participants |
| Part 2: TAK-020 25 mg CCT Fasted | Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE) | 1 participants |
| Part 2: TAK-020 25 mg CCT Fed | Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE) | 0 participants |
Secondary
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose
Time frame: Baseline up to Day 2
Population: The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: TAK-020 17.5 mg OS | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Hematology | 1 participants |
| Part 1: TAK-020 17.5 mg OS | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Chemistry | 0 participants |
| Part 1: TAK-020 17.5 mg CCT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Hematology | 0 participants |
| Part 1: TAK-020 17.5 mg CCT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Chemistry | 1 participants |
| Part 1: TAK-020 17.5 mg SDT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Hematology | 0 participants |
| Part 1: TAK-020 17.5 mg SDT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Chemistry | 0 participants |
| Part 1: TAK-020 17.5 mg IRT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Hematology | 0 participants |
| Part 1: TAK-020 17.5 mg IRT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Chemistry | 0 participants |
| Part 2: TAK-020 25 mg CCT Fasted | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Hematology | 0 participants |
| Part 2: TAK-020 25 mg CCT Fasted | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Chemistry | 0 participants |
| Part 2: TAK-020 25 mg CCT Fed | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Hematology | 0 participants |
| Part 2: TAK-020 25 mg CCT Fed | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose | Chemistry | 0 participants |
Secondary
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: Baseline up to Day 2
Population: The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: TAK-020 17.5 mg OS | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 5 participants |
| Part 1: TAK-020 17.5 mg CCT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 5 participants |
| Part 1: TAK-020 17.5 mg SDT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 4 participants |
| Part 1: TAK-020 17.5 mg IRT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 4 participants |
| Part 2: TAK-020 25 mg CCT Fasted | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 5 participants |
| Part 2: TAK-020 25 mg CCT Fed | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 3 participants |
Secondary
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: Baseline up to Day 2
Population: The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: TAK-020 17.5 mg OS | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 0 participants |
| Part 1: TAK-020 17.5 mg CCT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 1 participants |
| Part 1: TAK-020 17.5 mg SDT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 2 participants |
| Part 1: TAK-020 17.5 mg IRT | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 2 participants |
| Part 2: TAK-020 25 mg CCT Fasted | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 6 participants |
| Part 2: TAK-020 25 mg CCT Fed | Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 5 participants |