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| ID | Type | Description | Link |
|---|---|---|---|
| U111-1155-6022 | Registry Identifier | WHO |
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The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.
The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look at side effects and lab results in people who take TAK-935 and is designed as a randomized dose-rising study.
The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive a single dose of TAK-935 and 2 participants will receive placebo after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200, 600, 900 and not to exceed 1350 mg in subsequent cohorts.
This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 51 days. Participants will make 2 visits to the clinic, including one 7-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: TAK-935 15 mg | Experimental | TAK-935 15 mg solution, orally, once, on Day 1. |
|
| Cohort 2: TAK-935 50 mg | Experimental | TAK-935 50 mg solution, orally, once, on Day 1. |
|
| Cohort 3: TAK-935 200 mg | Experimental | TAK-935 200 mg solution, orally, once, on Day 1. |
|
| Cohort 4: TAK-935 600 mg | Experimental | TAK-935 600 mg solution, orally, once, on Day 1. |
|
| Cohort 5: TAK-935 900 mg | Experimental | TAK-935 900 mg solution, orally, once, on Day 1. |
|
| Cohort 6: TAK-935 1350 mg | Experimental | TAK-935 1350 mg solution, orally, once, on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-935 | Drug | TAK-935 oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) | 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 (eg, 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 and within 30 days after the last dose of study drug. | Day 1 to Day 30 |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period. | Day 1 to Day 14 |
| Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose | The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period. | Day 1 to Day 14 |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose | The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period. | Day 1 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-935 | Multiple time-points (Up to 96 hours) post-dose | |
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935 | Multiple time-points (Up to 96 hours) post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lincoln | Nebraska | United States |
Healthy Volunteers were enrolled in 1 of 7 treatment groups, once a day placebo, TAK 935 15 mg, 50 mg, 200 mg, 600 mg, 900 mg or 1350 mg.
Participants took part in the study at 1 investigative site in the United States from 09 July 2014 to 30 July 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohorts 1-6: Placebo | TAK-935 placebo-matching solution, orally, once, on Day 1. |
| FG001 | Cohort 1: TAK-935 15 mg | TAK-935 15 mg solution, orally, once, on Day 1. |
| FG002 | Cohort 2: TAK-935 50 mg | TAK-935 50 mg solution, orally, once, on Day 1. |
| FG003 | Cohort 3: TAK-935 200 mg | TAK-935 200 mg solution, orally, once, on Day 1. |
| FG004 | Cohort 4: TAK-935 600 mg | TAK-935 600 mg solution, orally, once, on Day 1. |
| FG005 | Cohort 5: TAK-935 900 mg | TAK-935 900 mg solution, orally, once, on Day 1. |
| FG006 | Cohort 6: TAK-935 1350 mg | TAK-935 1350 mg solution, orally, once, on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis was performed on safety set which included all participants who were enrolled and received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohorts 1-6: Placebo | TAK-935 placebo-matching solution, orally, once, on Day 1. |
| BG001 | Cohort 1: TAK-935 15 mg | TAK-935 15 mg solution, orally, once, on Day 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 | Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) | 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 (eg, 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 and within 30 days after the last dose of study drug. | Safety set included all participants who were enrolled and received study drug. | Posted | Number | percentage of participants | Day 1 to Day 30 |
|
30 Days
At each visit the investigator had to document any occurrence of adverse events, including and abnormal clinically significant abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment and/or intensity.
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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 | Cohorts 1-6: Placebo | TAK-935 placebo-matching solution, orally, once, on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Cohorts 1-6: Placebo | Placebo Comparator | TAK-935 placebo-matching solution, orally, once, on Day 1. |
|
| Placebo | Drug | TAK-935 placebo-matching oral solution |
|
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935 | Multiple time-points (Up to 96 hours) post-dose |
| BG002 | Cohort 2: TAK-935 50 mg | TAK-935 50 mg solution, orally, once, on Day 1. |
| BG003 | Cohort 3: TAK-935 200 mg | TAK-935 200 mg solution, orally, once, on Day 1. |
| BG004 | Cohort 4: TAK-935 600 mg | TAK-935 600 mg solution, orally, once, on Day 1. |
| BG005 | Cohort 5: TAK-935 900 mg | TAK-935 900 mg solution, orally, once, on Day 1. |
| BG006 | Cohort 6: TAK-935 1350 mg | TAK-935 1350 mg solution, orally, once, on Day 1. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
TAK-935 placebo-matching solution, orally, once, on Day 1.
| OG001 | Cohort 1: TAK-935 15 mg | TAK-935 15 mg solution, orally, once, on Day 1. |
| OG002 | Cohort 2: TAK-935 50 mg | TAK-935 50 mg solution, orally, once, on Day 1. |
| OG003 | Cohort 3: TAK-935 200 mg | TAK-935 200 mg solution, orally, once, on Day 1. |
| OG004 | Cohort 4: TAK-935 600 mg | TAK-935 600 mg solution, orally, once, on Day 1. |
| OG005 | Cohort 5: TAK-935 900 mg | TAK-935 900 mg solution, orally, once, on Day 1. |
| OG006 | Cohort 6: TAK-935 1350 mg | TAK-935 1350 mg solution, orally, once, on Day 1. |
|
|
| Primary | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period. | Safety set included all participants who were enrolled and received study drug. | Posted | Number | percentage of participants | Day 1 to Day 14 |
|
|
|
| Primary | Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose | The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period. | Safety set included all participants who were enrolled and received study drug. | Posted | Number | percentage of participants | Day 1 to Day 14 |
|
|
|
| Primary | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose | The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period. | Safety set included all participants who were enrolled and received study drug. | Posted | Number | percentage of participants | Day 1 to Day 14 |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-935 | Pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration. | Posted | Mean | Standard Deviation | ng/mL | Multiple time-points (Up to 96 hours) post-dose |
|
|
|
| Secondary | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935 | PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration. | Posted | Mean | Standard Deviation | ng*hr/mL | Multiple time-points (Up to 96 hours) post-dose |
|
|
|
| Secondary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935 | PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration. | Posted | Mean | Standard Deviation | ng*hr/mL | Multiple time-points (Up to 96 hours) post-dose |
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Cohort 1: TAK-935 15 mg | TAK-935 15 mg solution, orally, once, on Day 1. | 0 | 6 | 2 | 6 |
| EG002 | Cohort 2: TAK-935 50 mg | TAK-935 50 mg solution, orally, once, on Day 1. | 0 | 6 | 1 | 6 |
| EG003 | Cohort 3: TAK-935 200 mg | TAK-935 200 mg solution, orally, once, on Day 1. | 0 | 6 | 2 | 6 |
| EG004 | Cohort 4: TAK-935 600 mg | TAK-935 600 mg solution, orally, once, on Day 1. | 0 | 6 | 5 | 6 |
| EG005 | Cohort 5: TAK-935 900 mg | TAK-935 900 mg solution, orally, once, on Day 1. | 0 | 6 | 2 | 6 |
| EG006 | Cohort 6: TAK-935 1350 mg | TAK-935 1350 mg solution, orally, once, on Day 1. | 0 | 6 | 2 | 6 |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Application site dermatitis | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Application site erosion | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (17.0) | 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.