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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1165-3437 | Registry Identifier | WHO |
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This is a phase 1, randomized, double-blind, placebo-controlled, 2-center, multiple-dose study in healthy participants and participants with type 2 diabetes mellitus (T2DM). This study will evaluate the safety, tolerability and pharmacokinetics (PK) of TAK-648 when administered as multiple oral doses of TAK-648 solution at escalating dose levels in healthy participants of Japanese decent and participants with T2DM.
The drug being evaluated in this study is TAK-648 for the treatment of T2DM.
This study will consist of 2 parts: (1) multiple ascending doses in participants with T2DM treated with a stable dose of metformin, (2) multiple ascending doses in healthy participants of Japanese descent.
Part 1 of this study will consist of 2 multiple dose treatment cohorts (Cohorts 1-2 designated as P1C1 and P1C2) dosed sequentially in escalating order. The projected doses of TAK-648 for Part 1 are 0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower, and additional cohorts may be added, based on available safety and pharmacokinetic (PK) data. All cohorts in Part 1 will consist of 8 (2 placebo) T2DM participants.
Part 2 of this study will consist of 3 multiple dose treatment cohorts (Cohorts 1-3 designated as P2C1, P2C2 and P2C3) in healthy participants of Japanese descent dosed sequentially in escalating order. The projected doses of TAK-648 chosen for Part 2 are 0.05, 0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower based on available safety and PK data. All cohorts in Part 2 will consist of 8 (2 placebo) healthy participants of Japanese descent.
Additional cohorts may be recruited and studied as necessary to better evaluate safety, tolerability, PK, and/or PD parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Cohort 1: TAK-648 0.35 mg | Experimental | Participants with T2DM on a stable dose of metformin in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
|
| Part 1 Cohort 2: TAK-648 0.80 mg | Experimental | Participants with T2DM on a stable dose of metformin in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
|
| Part 1: Placebo Cohort 1-2 | Placebo Comparator | Participants with T2DM on a stable dose of metformin in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
|
| Part 2 Cohort 1: TAK-648 0.05 mg | Experimental | Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-648 | Drug | TAK-648 solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Up to Day 34 |
| Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2 | 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Up to Day 26 |
| Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1 | Up to Day 20 | |
| Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2 | Up to Day 13 | |
| Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1 | Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm). | Up to Day 20 |
| Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2 | Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm), |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Plasma Concentration for TAK-648 for Part 1 | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) | |
| Cmax: Maximum Plasma Concentration for TAK-648 for Part 2 | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
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Inclusion Criteria:
Part 1:
Part 2:
Exclusion Criteria:
Part 1:
Parts 1 and 2:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | United States | ||||
Participants with a diagnosis of Type 2 Diabetes Mellitus (T2DM) were enrolled in 1 of 3 treatment groups: placebo, 0.35 mg or 0.80 mg TAK-648 in Part 1. Healthy Japanese volunteers were enrolled in 1 of 5 treatment groups: placebo, 0.05 mg, 0.15 mg, 0.35 mg or 0.80 mg TAK-648 in Part 2.
Participants took part in the study at 2 investigative sites in the United States from 02 April 2015 to 04 November 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 Cohort 1: TAK-648 0.35 mg | Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| FG001 | Part 1 Cohort 2: TAK-648 0.80 mg | Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| FG002 | Part 1: Placebo Cohort 1-2 | Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| FG003 | Part 2 Cohort 1: TAK-648 0.05 mg | Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| FG004 | Part 2 Cohort 2: TAK-648 0.15 mg | Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| FG005 | Part 2 Cohort 3: TAK-648 0.35 mg | Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| FG006 | Part 2 Cohort 4: TAK-648 0.80 mg | Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| FG007 | Part 2: Placebo Cohort 1-4 | Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
| |||||||||||||
| Part 2 |
|
Randomized Set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 Cohort 1: TAK-648 0.35 mg | Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data presented for study Part 1 only. Age data for study Part 2 is reported in a separate baseline measure. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Day 34 |
|
AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 Cohort 1: TAK-648 0.35 mg | Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bundle branch block left | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director Clinical Science | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Part 2 Cohort 2: TAK-648 0.15 mg | Experimental | Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
|
| Part 2 Cohort 3: TAK-648 0.35 mg | Experimental | Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
|
| Part 2 Cohort 4: TAK-648 0.80 mg | Experimental | Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
|
| Part 2: Placebo Cohort 1-4 | Placebo Comparator | Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
|
| Placebo | Drug | TAK-648 placebo-matching solution |
|
| Up to Day 13 |
| Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1 | Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. | Up to Day 20 |
| Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2 | Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. | Up to Day 13 |
| Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1 | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) |
| Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2 | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1 | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) |
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2 | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
| AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1 | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) |
| AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2 | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
| AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1 | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) |
| AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2 | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
| Chula Vista |
| California |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 1 Cohort 2: TAK-648 0.80 mg |
Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| BG002 | Part 1: Placebo Cohort 1-2 | Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| BG003 | Part 2 Cohort 1: TAK-648 0.05 mg | Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| BG004 | Part 2 Cohort 2: TAK-648 0.15 mg | Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| BG005 | Part 2 Cohort 3: TAK-648 0.35 mg | Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| BG006 | Part 2 Cohort 4: TAK-648 0.80 mg | Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| BG007 | Part 2: Placebo Cohort 1-4 | Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| BG008 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | Data presented for study Part 2 only. Age data for study Part 1 is reported in a separate baseline measure. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Data presented for study Part 1 only. Gender data for study Part 2 is reported in a separate baseline measure. | Count of Participants | Participants |
|
| Sex: Female, Male | Data presented for study Part 2 only. Gender data for study Part 1 is reported in a separate baseline measure. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Data presented for study Part 1 only. Ethnicity data for study Part 2 is reported in a separate baseline measure. | Number | participants |
|
| Race/Ethnicity, Customized | Data presented for study Part 2 only. Ethnicity data for study Part 1 is reported in a separate baseline measure. | Number | participants |
|
| Race/Ethnicity, Customized | Data presented for study Part 1 only. Race data for study Part 2 is reported in a separate baseline measure. | Number | participants |
|
| Race/Ethnicity, Customized | Data presented for study Part 2 only. Race data for study Part 1 is reported in a separate baseline measure. | Number | participants |
|
| Region of Enrollment | Data presented for study Part 1 only. Region of enrollment data for study Part 2 is reported in a separate baseline measure. | Number | participants |
|
| Region of Enrollment | Data presented for study Part 2 only. Region of enrollment data for study Part 1 is reported in a separate baseline measure. | Number | participants |
|
| Height | Data presented for study Part 1 only. Height data for study Part 2 is reported in a separate baseline measure. | Mean | Standard Deviation | cm |
|
| Height | Data presented for study Part 2 only. Height data for study Part 1 is reported in a separate baseline measure. | Mean | Standard Deviation | cm |
|
| Weight | Data presented for study Part 1 only. Weight data for study Part 2 is reported in a separate baseline measure. | Mean | Standard Deviation | kg |
|
| Weight | Data presented for study Part 2 only. Weight data for study Part 1 is reported in a separate baseline measure. | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Data presented for study Part 1 only. BMI data for study Part 2 is reported in a separate baseline measure. | Mean | Standard Deviation | kg/m^2 |
|
| Body Mass Index (BMI) | Data presented for study Part 2 only. BMI data for study Part 1 is reported in a separate baseline measure. | Mean | Standard Deviation | kg/m^2 |
|
| Metformin Dose | Applies only to Part 1 only, participants with T2DM. | Mean | Standard Deviation | mg |
|
| Duration of Type 2 Diabetes Mellitus (T2DM) | Applies only to Part 1 only, participants with T2DM. | Mean | Standard Deviation | years |
|
| OG001 | Part 1 Cohort 2: TAK-648 0.80 mg | Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| OG002 | Part 1: Placebo Cohort 1-2 | Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
|
|
| Primary | Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2 | 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Day 26 |
|
|
|
| Primary | Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1 | Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Day 20 |
|
|
|
| Primary | Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2 | Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Day 13 |
|
|
|
| Primary | Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1 | Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm). | Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Day 20 |
|
|
|
| Primary | Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2 | Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm), | Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Day 13 |
|
|
|
| Primary | Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1 | Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. | Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Day 20 |
|
|
|
| Primary | Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2 | Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. | Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Day 13 |
|
|
|
| Secondary | Cmax: Maximum Plasma Concentration for TAK-648 for Part 1 | The Pharmacokinetic (PK) Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| Secondary | Cmax: Maximum Plasma Concentration for TAK-648 for Part 2 | The PK Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | mg/mL | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| Secondary | Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1 | The PK Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Median | Full Range | hours (hr) | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| Secondary | Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2 | The PK Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Median | Full Range | hr | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| Secondary | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1 | The PK Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| Secondary | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2 | The PK Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| Secondary | AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1 | The PK Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| Secondary | AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2 | The PK Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| Secondary | AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1 | The PK Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| Secondary | AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2 | The PK Set included all participants in the safety set with at least 1 measurable plasma concentration. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours) |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Part 1 Cohort 2: TAK-648 0.80 mg | Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). | 0 | 6 | 2 | 6 |
| EG002 | Part 1: Placebo Cohort 1-2 | Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). | 0 | 4 | 4 | 4 |
| EG003 | Part 2 Cohort 1: TAK-648 0.05 mg | Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). | 0 | 6 | 6 | 6 |
| EG004 | Part 2 Cohort 2: TAK-648 0.15 mg | Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). | 0 | 6 | 2 | 6 |
| EG005 | Part 2 Cohort 3: TAK-648 0.35 mg | Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). | 0 | 6 | 4 | 6 |
| EG006 | Part 2 Cohort 4: TAK-648 0.80 mg | Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). | 0 | 6 | 5 | 6 |
| EG007 | Part 2: Placebo Cohort 1-4 | Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). | 0 | 8 | 3 | 8 |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Application site dermatitis | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Application site irritation | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Application site reaction | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Blood pressure orthostatic decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|---|
|
| > Upper Criteria |
|
| Day 10 |
|
| Day 10 |
|
| Day 10 |
|
| Day 10 |
|
| Day 10 |
|