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This is a study of TAK-951 for people with symptoms of nausea and vomiting. The main aims of this study in healthy adults are as follows:
Participants will receive a single infusion of either TAK-951 or placebo. In this study, a placebo looks like TAK-951 but does not have any medicine in it. Participants will receive either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours.
Participants will stay in the study clinic for about 4 days to receive the study medicine (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the clinic about 2 weeks and 4 weeks after treatment.
The drug being tested in this study is called TAK-951. The study evaluated the safety, tolerability and pharmacokinetics (PK) of TAK-951 in healthy participants.
The study enrolled 128 healthy participants and consisted of 2 parts: Single-rising Dose (SRD) part (13 cohorts) of sequential panel design, and Multiple-rising Dose (MRD) part (5 cohorts) of sequential panel design. Participants in each cohort were randomized to receive treatment with TAK-951 or matching placebo using SC injection, once daily on Day 1 (for SRD part) and twice daily (BID) on Days 1 through 5 (for MRD part) following a minimum fast of 8 hours.
This single center trial was conducted in the United States. The overall time to participate in this study was approximately 155 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (SRD): Pooled Placebo | Placebo Comparator | TAK-951 placebo-matching, single dose, subcutaneous (SC) injection, on Day 1 in fasted healthy participants in the single-rising dose (SRD) period. |
|
| Part 1 (SRD): Cohort 2: TAK-951 Dose 1 | Experimental | TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 1: TAK-951 Dose 2 | Experimental | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 15: TAK-951 Dose 2 | Experimental | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 3: TAK-951 Dose 3 | Experimental | TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-951 Placebo | Drug | TAK-951 placebo-matching SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 3: Percentage of Participants With Clinically Significant Physical Examination Findings | Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax. | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
| Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters | The criteria for markedly abnormal values of vital signs' parameters were: Pulse Rate (beats/minute) <50 and >120; Systolic Blood Pressure [millimeters of mercury (mmHg)] <85 and >180; Diastolic Blood Pressure (mmHg) <50 and >110; Temperature [degrees Celsius (C)] <35.6 and >37.7. Only categories with atleast one participant with events are reported. | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
| Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters | The criteria for markedly abnormal values of 12-lead ECG parameters were: ECG Mean Heart Rate (beats/min) <50 beats per minute and >120 beats per minute; PR Interval, Aggregate [milliseconds (msec)] <=80 msec and >=200 msec; QRS Duration, Aggregate (msec) <=80 msec and >=120 msec; QT Interval with Fridericia Correction Method (QTcF) Interval, Aggregate (msec) >=500 msec or >=30 msec change from Baseline and >=450 msec. Only categories with atleast one participant with event are reported. | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
| Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Laboratory Parameters | The laboratory parameters of chemistry, and hematology were assessed. Clinical laboratory tests included serum chemistry, hematology, and urinalysis. MAV criteria: Alanine aminotransferase(U/L) >3xupper limit of normal(ULN); Albumin<2.5g/dL,<25g/L; Alkaline phosphatase (U/L)>3 x ULN; Aspartate aminotransferase (U/L)>3 x ULN; Bilirubin>1.5mg/dL, >34.2 µmol/L; Calcium<8.0 mg/dL,LLN-<2.0mmol/L, >1.0mmol/L; Carbon dioxide <8.0 (mmol/L); Chloride<75 mmol/L,>126 mmol/L; Creatinine>177µmol/L; Gamma glutamyl transferase (U/L)>2.0 mg/dL, >3.0 x ULN; Glucose<3 mmol/L,>10 mmol/L; Potassium<3.0 mmol/L >5.5 mmol/L; Protein(g/L)<0.8 x LLN >1.2 x ULN; Sodium<130mmol/L >150mmol/L; Urea nitrogen >10.7; Erythrocytes 10^12erythrocytes/L) <0.8 x LLN,>1.2 x ULN; Hematocrit(%) <0.8 x LLN,>1.2xULN; Hemoglobin(g/L)<0.8 x LLN, >1.2 x ULN; Leukocytes(10^9 leukocytes/L)<0.5 x LLN >1.5 x ULN; platelets(10^9 platelets/L)<75->600. Only categories with atleast one participant with event are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-951 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1 | |
| Part 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1 |
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Inclusion Criteria:
1. Have a body mass index (BMI) ≥18 and ≤30.0 (kg/m^2) at the Screening Visit.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| To obtain more information about this study, click this link. | View source |
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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.
Healthy participants were enrolled into Part 1 and Part 3 of this study. Participants were randomized into 12 cohorts in Part 1 to receive single-rising dose (SRD) and into 4 cohorts in Part 3 to receive multiple-rising doses (MRD) of TAK-951 or matching placebo in a 3:1 ratio. The randomization in Part 3 was based on the safe and tolerable doses determined in Part 1. As pre-specified in the protocol, Part 2 of the study was not conducted.
Participants took part in the study at 1 investigative site in the United States from 07 March 2019 to 02 November 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 (SRD): Pooled Placebo | TAK-951 placebo-matching, single dose, subcutaneous (SC) injection, on Day 1 in fasted healthy participants in the single-rising dose (SRD) period. |
| FG001 | Part 1 (SRD): Cohort 2: TAK-951 Dose 1 | TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG002 | Part 1 (SRD): Cohort 1: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG003 | Part 1 (SRD): Cohort 15: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG004 | Part 1 (SRD): Cohort 3: TAK-951 Dose 3 | TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG005 | Part 1 (SRD): Cohort 4: TAK-951 Dose 4 | TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG006 | Part 1 (SRD): Cohort 5: TAK-951 Dose 5 | TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG007 | Part 1 (SRD): Cohort 6: TAK-951 Dose 6 | TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG008 | Part 1 (SRD): Cohort 13: TAK-951 Dose 7 | TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG009 | Part 1 (SRD): Cohort 14: TAK-951 Dose 8 | TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG010 | Part 1 (SRD): Cohort 16: TAK-951 Dose 9 | TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG011 | Part 1 (SRD): Cohort 17: TAK-951 Dose 10 | TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG012 | Part 1 (SRD): Cohort 18: TAK-951 Dose 11 | TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| FG013 | Part 3 (MRD): Pooled Placebo | TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| FG014 | Part 3 (MRD): Cohort 10: TAK-951 Dose 1A | TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| FG015 | Part 3 (MRD): Cohort 11: TAK-951 Dose 2A | TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| FG016 | Part 3 (MRD): Cohort 12: TAK-951 Dose 3A | TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| FG017 | Part 3 (MRD): Cohort 20: TAK-951 Dose 4A | TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 (SRD): Pooled Placebo | TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG001 | Part 1 (SRD): Cohort 2: TAK-951 Dose 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Parts 1 and 3: Percentage of Participants With Clinically Significant Physical Examination Findings | Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax. | Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. | Posted | Number | percentage of participants | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
|
From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
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 (SRD): Pooled Placebo | TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | MedDRA 23 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2020 | Oct 31, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2020 | Oct 31, 2022 | SAP_001.pdf |
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| Part 1 (SRD): Cohort 4: TAK-951 Dose 4 |
| Experimental |
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 5: TAK-951 Dose 5 | Experimental | TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 6: TAK-951 Dose 6 | Experimental | TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 13: TAK-951 Dose 7 | Experimental | TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 14: TAK-951 Dose 8 | Experimental | TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 16: TAK-951 Dose 9 | Experimental | TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 17: TAK-951 Dose 10 | Experimental | TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 1 (SRD): Cohort 18: TAK-951 Dose 11 | Experimental | TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
|
| Part 3 (MRD): Pooled Placebo | Placebo Comparator | TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the multiple-rising dose (MRD) period. |
|
| Part 3 (MRD): Cohort 10: TAK-951 Dose 1A | Experimental | TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
|
| Part 3 (MRD): Cohort 11: TAK-951 Dose 2A | Experimental | TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
|
| Part 3 (MRD): Cohort 12: TAK-951 Dose 3A | Experimental | TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
|
| Part 3 (MRD): Cohort 20: TAK-951 Dose 4A | Experimental | TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
|
| TAK-951 | Drug | TAK-951 SC injection |
|
| From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
| Parts 1 and 3: Percentage of Participants With Treatment-Emergent Adverse Events | 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 (example, 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 TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
| Parts 1 and 3: Percentage of Participants With Positive Immunogenicity (ADA) Status | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
| Part 3: Cmax: Maximum Observed Plasma Concentration for TAK-951 on Day 1 | Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3 |
| Part 3: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval Tau (τ), From Time of First Daily Dose to 8 Hours for TAK-951 on Day 1 | Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3 |
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
| BG002 | Part 1 (SRD): Cohort 1: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG003 | Part 1 (SRD): Cohort 15: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG004 | Part 1 (SRD): Cohort 3: TAK-951 Dose 3 | TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG005 | Part 1 (SRD): Cohort 4: TAK-951 Dose 4 | TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG006 | Part 1 (SRD): Cohort 5: TAK-951 Dose 5 | TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG007 | Part 1 (SRD): Cohort 6: TAK-951 Dose 6 | TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG008 | Part 1 (SRD): Cohort 13: TAK-951 Dose 7 | TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG009 | Part 1 (SRD): Cohort 14: TAK-951 Dose 8 | TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG010 | Part 1 (SRD): Cohort 16: TAK-951 Dose 9 | TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG011 | Part 1 (SRD): Cohort 17: TAK-951 Dose 10 | TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG012 | Part 1 (SRD): Cohort 18: TAK-951 Dose 11 | TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| BG013 | Part 3 (MRD): Pooled Placebo | TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| BG014 | Part 3 (MRD): Cohort 10: TAK-951 Dose 1A | TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| BG015 | Part 3 (MRD): Cohort 11: TAK-951 Dose 2A | TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| BG016 | Part 3 (MRD): Cohort 12: TAK-951 Dose 3A | TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| BG017 | Part 3 (MRD): Cohort 20: TAK-951 Dose 4A | TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| BG018 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Full Range | kg |
|
| Height | Mean | Full Range | cm |
|
| Body Mass Index (BMI) | BMI=weight (kg) / [height (m)]^2 | Mean | Full Range | kg/m^2 |
|
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG002 | Part 1 (SRD): Cohort 1: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG003 | Part 1 (SRD): Cohort 15: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG004 | Part 1 (SRD): Cohort 3: TAK-951 Dose 3 | TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG005 | Part 1 (SRD): Cohort 4: TAK-951 Dose 4 | TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG006 | Part 1 (SRD): Cohort 5: TAK-951 Dose 5 | TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG007 | Part 1 (SRD): Cohort 6: TAK-951 Dose 6 | TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG008 | Part 1 (SRD): Cohort 13: TAK-951 Dose 7 | TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG009 | Part 1 (SRD): Cohort 14: TAK-951 Dose 8 | TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG010 | Part 1 (SRD): Cohort 16: TAK-951 Dose 9 | TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG011 | Part 1 (SRD): Cohort 17: TAK-951 Dose 10 | TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG012 | Part 1 (SRD): Cohort 18: TAK-951 Dose 11 | TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| OG013 | Part 3 (MRD): Pooled Placebo | TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| OG014 | Part 3 (MRD): Cohort 10: TAK-951 Dose 1A | TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| OG015 | Part 3 (MRD): Cohort 11: TAK-951 Dose 2A | TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| OG016 | Part 3 (MRD): Cohort 12: TAK-951 Dose 3A | TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| OG017 | Part 3 (MRD): Cohort 20: TAK-951 Dose 4A | TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
|
|
| Primary | Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters | The criteria for markedly abnormal values of vital signs' parameters were: Pulse Rate (beats/minute) <50 and >120; Systolic Blood Pressure [millimeters of mercury (mmHg)] <85 and >180; Diastolic Blood Pressure (mmHg) <50 and >110; Temperature [degrees Celsius (C)] <35.6 and >37.7. Only categories with atleast one participant with events are reported. | Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. The values are rounded off to the nearest whole number. | Posted | Number | percentage of participants | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
|
|
|
| Primary | Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters | The criteria for markedly abnormal values of 12-lead ECG parameters were: ECG Mean Heart Rate (beats/min) <50 beats per minute and >120 beats per minute; PR Interval, Aggregate [milliseconds (msec)] <=80 msec and >=200 msec; QRS Duration, Aggregate (msec) <=80 msec and >=120 msec; QT Interval with Fridericia Correction Method (QTcF) Interval, Aggregate (msec) >=500 msec or >=30 msec change from Baseline and >=450 msec. Only categories with atleast one participant with event are reported. | Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. The values are rounded off to the nearest whole number. | Posted | Number | percentage of participants | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
|
|
|
| Primary | Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Laboratory Parameters | The laboratory parameters of chemistry, and hematology were assessed. Clinical laboratory tests included serum chemistry, hematology, and urinalysis. MAV criteria: Alanine aminotransferase(U/L) >3xupper limit of normal(ULN); Albumin<2.5g/dL,<25g/L; Alkaline phosphatase (U/L)>3 x ULN; Aspartate aminotransferase (U/L)>3 x ULN; Bilirubin>1.5mg/dL, >34.2 µmol/L; Calcium<8.0 mg/dL,LLN-<2.0mmol/L, >1.0mmol/L; Carbon dioxide <8.0 (mmol/L); Chloride<75 mmol/L,>126 mmol/L; Creatinine>177µmol/L; Gamma glutamyl transferase (U/L)>2.0 mg/dL, >3.0 x ULN; Glucose<3 mmol/L,>10 mmol/L; Potassium<3.0 mmol/L >5.5 mmol/L; Protein(g/L)<0.8 x LLN >1.2 x ULN; Sodium<130mmol/L >150mmol/L; Urea nitrogen >10.7; Erythrocytes 10^12erythrocytes/L) <0.8 x LLN,>1.2 x ULN; Hematocrit(%) <0.8 x LLN,>1.2xULN; Hemoglobin(g/L)<0.8 x LLN, >1.2 x ULN; Leukocytes(10^9 leukocytes/L)<0.5 x LLN >1.5 x ULN; platelets(10^9 platelets/L)<75->600. Only categories with atleast one participant with event are reported. | Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. | Posted | Number | percentage of participants | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
|
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| Primary | Parts 1 and 3: Percentage of Participants With Treatment-Emergent Adverse Events | 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 (example, 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 TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. | Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. The values are rounded off to the nearest whole number. | Posted | Number | percentage of participants | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
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| Primary | Parts 1 and 3: Percentage of Participants With Positive Immunogenicity (ADA) Status | Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. | Posted | Number | percentage of participants | From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days) |
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| Secondary | Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-951 | Part 1: Pharmacokinetic (PK) Set included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms per milliliters (pg/mL) | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1 |
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| Secondary | Part 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951 | PK Set (Part 1) included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 1. Two participants were excluded from the overall number analyzed from 'Part 1 (SRD): Cohort 6: TAK-951 Dose 6' arm as their values were derived from poorly estimated elimination phase during the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms*hour per milliliters(pg*hr/mL) | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1 |
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| Secondary | Part 3: Cmax: Maximum Observed Plasma Concentration for TAK-951 on Day 1 | PK Set (Part 3) included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 3. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3 |
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| Secondary | Part 3: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval Tau (τ), From Time of First Daily Dose to 8 Hours for TAK-951 on Day 1 | PK Set (Part 3) included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 3. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*hr/mL | Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3 |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Part 1 (SRD): Cohort 2: TAK-951 Dose 1 | TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Part 1 (SRD): Cohort 1: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Part 1 (SRD): Cohort 15: TAK-951 Dose 2 | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Part 1 (SRD): Cohort 3: TAK-951 Dose 3 | TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | Part 1 (SRD): Cohort 4: TAK-951 Dose 4 | TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | Part 1 (SRD): Cohort 5: TAK-951 Dose 5 | TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG007 | Part 1 (SRD): Cohort 6: TAK-951 Dose 6 | TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG008 | Part 1 (SRD): Cohort 13: TAK-951 Dose 7 | TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG009 | Part 1 (SRD): Cohort 14: TAK-951 Dose 8 | TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG010 | Part 1 (SRD): Cohort 16: TAK-951 Dose 9 | TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG011 | Part 1 (SRD): Cohort 17: TAK-951 Dose 10 | TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG012 | Part 1 (SRD): Cohort 18: TAK-951 Dose 11 | TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG013 | Part 3 (MRD): Pooled Placebo | TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG014 | Part 3 (MRD): Cohort 10: TAK-951 Dose 1A | TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG015 | Part 3 (MRD): Cohort 11: TAK-951 Dose 2A | TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | 6 | 1 | 6 | 5 | 6 |
| EG016 | Part 3 (MRD): Cohort 12: TAK-951 Dose 3A | TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG017 | Part 3 (MRD): Cohort 20: TAK-951 Dose 4A | TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. | 0 | 6 | 0 | 6 | 5 | 6 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
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| Accelerated idioventricular rhythm | Cardiac disorders | MedDRA 23 | Systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA 23 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 23 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
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| Bradyphrenia | Psychiatric disorders | MedDRA 23 | Systematic Assessment |
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| Chills | General disorders | MedDRA 23 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 23 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 23 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23 | Systematic Assessment |
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| Faeces discoloured | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 23 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 23 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 23 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 23 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 23 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 23 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 23 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 23 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 23 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 23 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 23 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 23 | Systematic Assessment |
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| Postural orthostatic tachycardia syndrome | Cardiac disorders | MedDRA 23 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 23 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 23 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 23 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23 | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 23 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 23 | Systematic Assessment |
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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.
| Pulse Rate (beats/minute) <50 |
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| Pulse Rate (beats/minute) >120 |
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| Systolic Blood Pressure (mmHg) <85 |
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| Temperature (C) <35.6 |
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| PR Interval, Aggregate (msec) >=200 |
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| QRS Duration, Aggregate (msec) <=80 |
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| Glucose (mmol/L) >10 |
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| Urea Nitrogen (mmol/L) >10.7 |
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