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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1196-9143 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants with Gastroparesis (GP).
The drug being tested in this study is called TAK-906 maleate. TAK-906 maleate is being tested to treat people who have DG or IG. This study will assess the safety, tolerability, PK/PD and food effect of TAK-906 and will determine the effect of TAK-906 on gastric emptying (GE).
The study enrolled a total of 51 participants. This study will be conducted in two parts: Part 1 and Part 2. Part 1 will consist of 48 participants enrolled in 3 active treatment groups and 1 placebo group. Participants in Part 1 will be randomly assigned (by chance, like flipping a coin) to one of the 3 active treatment groups or 1 placebo group-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
All participants who will complete Part 1 of the study will be eligible for enrollment in Part 2. Part 2 consisted of 21 participants who completed Part 1 and were assigned to the 2 open-label treatment groups as follow:
This multi-center trial will be conducted the United States. The overall time to participate in this study is approximately 8 weeks. Participants will make a final visit to the clinic 10-14 days after receiving their last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Placebo | Placebo Comparator | TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions. |
|
| Part 1: TAK 906 Maleate 5 mg | Experimental | TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions. |
|
| Part 1: TAK 906 Maleate 25 mg | Experimental | TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions. |
|
| Part 1: TAK 906 Maleate 100 mg | Experimental | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
|
| Part 2: TAK-906 Maleate 25 mg Fed Condition | Experimental | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (high fat breakfast), followed by a minimum 7- day washout. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-906 Maleate | Drug | TAK-906 Maleate Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any following reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. | From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days) |
| Number of Participants With Markedly Abnormal Laboratory Parameters Values | Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN),albumin<25 g/L*lower limit of normal(LLN),alkaline phosphatase >3.0 U/L*ULN,aspartate aminotransferase >3.0 U/L*ULN,bilirubin >2 umol/L*ULN,blood urea nitrogen(BUN) >10.7 mmol/L,calcium <1.75 mmol/L, >2.88 mmol/L,chloride <75 mmol/L, >126 mmol/L,creatinine >177umol/L,gamma glutamyl transferase (GGT) >3 U/L*ULN,glucose <2.8 mmol/L, >19.4 mmol/L,phosphate <0.52 mmol/L, >2.10 mmol/L,potassium<3 mmol/L, >6 mmol/L,sodium <130 mmol/L, >150 mmol/L,hematocrit (%) <0.8*LLN, >1.2*ULN,hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN,leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN,erythrocytes<0.8 (10^12/L)*LLN, >1.2(10^12/L)*ULN,platelets <75(10^9/L), >600(10^9/L). Participants with at least 1 markedly abnormal laboratory parameter value is reported. | From Baseline to 14 days after the last dose of study drug in Part 1 (Up to approximately 23 days) |
| Number of Participants With Markedly Abnormal Vital Signs |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Prolactin Concentration on Day 1 at Tmax, Time of First Occurrence of Maximum Serum Concentration (Cmax) for TAK-906 Maleate for Part 1 | Change in serum prolactin on Day 1 at the Tmax, time of first occurrence of maximum serum concentration (Cmax) relative to Baseline was calculated as a ratio of maximum serum prolactin concentration on Day 1 to serum prolactin concentration at Baseline. |
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Inclusion Criteria
In order to be eligible for participation in this trial, the participant must:
Exclusion Criteria
The participant must be excluded from participating in the trial if the participant:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 9171 West Thunderbird Road | Peoria | Arizona | 85381 | United States | ||
| 850 North Kolb Road |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34148244 | Derived | Kuo B, Scimia C, Dukes G, Zhang W, Gupta S, Chen C, Chuang E, Camilleri M. Randomised clinical trial: safety, pharmacokinetics and pharmacodynamics of trazpiroben (TAK-906), a dopamine D2 /D3 receptor antagonist, in patients with gastroparesis. Aliment Pharmacol Ther. 2021 Aug;54(3):267-280. doi: 10.1111/apt.16451. Epub 2021 Jun 20. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of diabetes mellitus and gastroparesis (GP) or with idiopathic gastroparesis (IG) were enrolled. 51 participants were randomized in Part 1, out of which 48 completed the Part 1, 21 of 48 participants entered the Part 2.
Participants took part in the study at 7 investigative sites in the United States from 26 September 2017 to 09 March 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Placebo | TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions. |
| FG001 | Part 1: TAK 906 Maleate 5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 (Days 1 to 9) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2018 | May 16, 2019 |
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The study has two parts: Part 1 (double-blind) and Part 2 (open-label).
|
| Part 2: TAK-906 Maleate 25 mg Fasted Condition | Experimental | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions. |
|
| Part 2: Metoclopramide 10 mg | Active Comparator | Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. |
|
| Metaclopramide | Drug | Metaclopramide Tablets |
|
| TAK-906 Maleate Placebo | Drug | TAK-906 placebo-matching Capsules |
|
Vital signs included body temperature, diastolic and systolic blood pressure (mmHg), and heart rate (beats per minute [bpm]). Heart rate<50 bpm and systolic blood pressure <85 mmHg were considered markedly abnormal. |
| From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days) |
| Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values | The 12-lead electrocardiogram (ECG) values outside the range Heart Rate <50 (beats/min), PR Interval ≤120 (msec), PR Interval ≥200 (msec), QRS Duration ≥120 (msec), QT Interval ≥460 (msec) were considered markedly abnormal. | From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days) |
| Day 1 predose (Baseline), 1 hour and at multiple timepoints (Up to 8 hours) postdose |
| Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1 | The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT. | Baseline and Day 7 |
| Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1 | The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT. | Baseline and Day 1 of Part 1 |
| Percent Change From Baseline in Gastric Emptying (GE) Time as Measured by the SmartPill on Day 7 for Part 1 | SmartPill is an ingestible capsule that measures pressure, potential of hydrogen (pH) and temperature as it travels through the gastrointestinal (GI) tract to assess GE and GI motility. SmartPill eliminates radiation exposure and is the only motility test that provides a complete transit profile of the GI tract. | Baseline and Day 7 |
| AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1 | Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose |
| Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1 | Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose |
| Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1 | Part 1: Predose on Days 2, 3, 4, 5, 6, 7, 8 and 9 |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1 | Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose |
| Tucson |
| Arizona |
| 85710 |
| United States |
| 11219 Financial Centre Parkway | Little Rock | Arkansas | 72211 | United States |
| 13055 Southwest 42nd Street | Miami | Florida | 33175 | United States |
| 8200 Southwest 117th Avenue | Miami | Florida | 33183 | United States |
| 125 Clairemont Avenue | Decatur | Georgia | 30030 | United States |
| 616 South Washington Street | Bastrop | Louisiana | 71220 | United States |
| 6035 Shallowford Road | Chattanooga | Tennessee | 37421 | United States |
| 26 Stonecreek Circle | Jackson | Tennessee | 38305 | United States |
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
| FG002 | Part 1: TAK 906 Maleate 25 mg | TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions. |
| FG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
| FG004 | Part 2: TAK-906 Maleate 25 mg Under Fed Conditions | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) followed by fasted condition. There was a minimum 7- day washout period between the two conditions. |
| FG005 | Part 2: TAK-906 Maleate 25 mg Fasted Condition | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions. |
| FG006 | Part 2: Metoclopramide 10 mg | Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions. |
| COMPLETED |
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| NOT COMPLETED |
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| Part 2: Days 17 to 25 |
|
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| Part 2: Period 2: Fasted (Day 25) |
|
Safety analysis set (SAS), Part 1, included all participants who were randomized (Part 1) and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Placebo | TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions. |
| BG001 | Part 1: TAK 906 Maleate 5 mg | TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions. |
| BG002 | Part 1: TAK 906 Maleate 25 mg | TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions. |
| BG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Body Mass Index = weight/[height^2] | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Underlying Disease | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any following reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. | SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part. | Posted | Count of Participants | Participants | From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days) |
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| Primary | Number of Participants With Markedly Abnormal Laboratory Parameters Values | Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN),albumin<25 g/L*lower limit of normal(LLN),alkaline phosphatase >3.0 U/L*ULN,aspartate aminotransferase >3.0 U/L*ULN,bilirubin >2 umol/L*ULN,blood urea nitrogen(BUN) >10.7 mmol/L,calcium <1.75 mmol/L, >2.88 mmol/L,chloride <75 mmol/L, >126 mmol/L,creatinine >177umol/L,gamma glutamyl transferase (GGT) >3 U/L*ULN,glucose <2.8 mmol/L, >19.4 mmol/L,phosphate <0.52 mmol/L, >2.10 mmol/L,potassium<3 mmol/L, >6 mmol/L,sodium <130 mmol/L, >150 mmol/L,hematocrit (%) <0.8*LLN, >1.2*ULN,hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN,leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN,erythrocytes<0.8 (10^12/L)*LLN, >1.2(10^12/L)*ULN,platelets <75(10^9/L), >600(10^9/L). Participants with at least 1 markedly abnormal laboratory parameter value is reported. | SAS included all participants who were randomized and received at least 1 dose of study drug in the Part 1. Laboratory assessment were performed only in Part 1 of the study. Number analyzed are participants with data available for the particular parameter. | Posted | Count of Participants | Participants | From Baseline to 14 days after the last dose of study drug in Part 1 (Up to approximately 23 days) |
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| Primary | Number of Participants With Markedly Abnormal Vital Signs | Vital signs included body temperature, diastolic and systolic blood pressure (mmHg), and heart rate (beats per minute [bpm]). Heart rate<50 bpm and systolic blood pressure <85 mmHg were considered markedly abnormal. | SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part. | Posted | Count of Participants | Participants | From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days) |
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| Primary | Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values | The 12-lead electrocardiogram (ECG) values outside the range Heart Rate <50 (beats/min), PR Interval ≤120 (msec), PR Interval ≥200 (msec), QRS Duration ≥120 (msec), QT Interval ≥460 (msec) were considered markedly abnormal. | SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part. | Posted | Count of Participants | Participants | From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days) |
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| Secondary | Change From Baseline in Serum Prolactin Concentration on Day 1 at Tmax, Time of First Occurrence of Maximum Serum Concentration (Cmax) for TAK-906 Maleate for Part 1 | Change in serum prolactin on Day 1 at the Tmax, time of first occurrence of maximum serum concentration (Cmax) relative to Baseline was calculated as a ratio of maximum serum prolactin concentration on Day 1 to serum prolactin concentration at Baseline. | Full analysis set (FAS) included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for at least one of pharmacodynamic (PD) measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure. | Posted | Mean | Standard Deviation | ratio | Day 1 predose (Baseline), 1 hour and at multiple timepoints (Up to 8 hours) postdose |
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| Secondary | Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1 | The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT. | FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurement. Overall number of participants analyzed are the participants with evaluable data for this outcome measure. | Posted | Mean | Standard Deviation | min | Baseline and Day 7 |
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| Secondary | Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1 | The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT. | FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline at least 1 valid postbaseline value for assessment of at least one PD measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure. | Posted | Mean | Standard Deviation | minute (min) | Baseline and Day 1 of Part 1 |
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| Secondary | Percent Change From Baseline in Gastric Emptying (GE) Time as Measured by the SmartPill on Day 7 for Part 1 | SmartPill is an ingestible capsule that measures pressure, potential of hydrogen (pH) and temperature as it travels through the gastrointestinal (GI) tract to assess GE and GI motility. SmartPill eliminates radiation exposure and is the only motility test that provides a complete transit profile of the GI tract. | FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurements. Overall number of participants analyzed is number of participants with evaluable data for this outcome measure. | Posted | Mean | Standard Deviation | percent change in GE time | Baseline and Day 7 |
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| Secondary | AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1 | Pharmacokinetic (PK) set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of AUCt. Number analyzed are participants with evaluable data at given time-point. | Posted | Mean | Standard Deviation | h*ng/mL | Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose |
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| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1 | PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Cmax. Number analyzed are participants with evaluable data at given time-point. | Posted | Mean | Standard Deviation | ng/mL | Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose |
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| Secondary | Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1 | PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Ctrough. Number analyzed are participants with evaluable data at given time-point. | Posted | Mean | Standard Deviation | ng/mL | Part 1: Predose on Days 2, 3, 4, 5, 6, 7, 8 and 9 |
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| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1 | PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Tmax. Number analyzed are participants with evaluable data at given time-point. | Posted | Median | Full Range | hour (hr) | Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose |
|
Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. 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.
Not provided
| 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: Placebo | TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions. | 0 | 12 | 1 | 12 | 3 | 12 |
| EG001 | Part 1: TAK 906 Maleate 5 mg | TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions. | 0 | 14 | 0 | 14 | 4 | 14 |
| EG002 | Part 1: TAK 906 Maleate 25 mg | TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions. | 0 | 12 | 0 | 12 | 3 | 12 |
| EG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. | 0 | 13 | 1 | 13 | 4 | 13 |
| EG004 | Part 2: TAK-906 Maleate 25 mg Fed Condition | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | Part 2: TAK-906 Maleate 25 mg Fasted Condition | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG006 | Part 2: Metoclopramide 10 mg | Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions. | 0 | 13 | 0 | 13 | 1 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA version 21.0 | Systematic Assessment | Participant in Part 1: TAK 906 Maleate 100 mg had an AE of liver function test increased on Day 1. The blood draw for the liver function tests was done prior to the first study drug administration. |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment | A mild AE of tremor occurred in 1 participant (had history of diabetes) in Part 1:TAK 906 Maleate 100 mg arm, on Day 3, resolved on Day 4, considered not related by investigator. No other signs/symptoms of neurological origin were observed. |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 14, 2017 | May 16, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
Not provided
Not provided
| Withdrawal by Subject |
|
| Male |
|
| Non-Hispanic and Latino |
|
| White |
|
| Multiracial |
|
| Idiopathic Gastroparesis (IG) |
|
| SAEs |
|
| OG001 | Part 1: TAK 906 Maleate 5 mg | TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions. |
| OG002 | Part 1: TAK 906 Maleate 25 mg | TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions. |
| OG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
|
|
| OG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
| OG004 | Part 2: TAK-906 Maleate 25 mg Fed Condition | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period. |
| OG005 | Part 2: TAK-906 Maleate 25 mg Fasted Condition | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions. |
| OG006 | Part 2: Metoclopramide 10 mg | Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions. |
|
|
| OG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
| OG004 | Part 2: TAK-906 Maleate 25 mg Fed Condition | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period. |
| OG005 | Part 2: TAK-906 Maleate 25 mg Fasted Condition | TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions. |
| OG006 | Part 2: Metoclopramide 10 mg | Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions. |
|
|
| Part 1: TAK 906 Maleate 25 mg |
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions. |
| OG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
|
|
|
| OG002 | Part 1: TAK 906 Maleate 25 mg | TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions. |
| OG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
|
|
|
| OG002 | Part 1: TAK 906 Maleate 25 mg | TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions. |
| OG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
|
|
|
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions. |
| OG003 | Part 1: TAK 906 Maleate 100 mg | TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions. |
|
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