Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1189-8001 | Registry Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Takeda | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy participants.
The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants under fasting and fed conditions in order to determine the effect of food on the PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-831 400 mg Fasted + TAK-831 400 mg Fed | Experimental | TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 2. |
|
| TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Experimental | TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-831 | Drug | TAK-831 film-coated tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-831 | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose | |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose | |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) | Day 1 |
Not provided
Inclusion Criteria:
1. Weighs greater than or equal to (>=) 45 kilogram (kg) and has a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Lenexa | Kansas | 66219 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Healthy participants were enrolled in this 2-way crossover study and randomized in 1 of the 2 treatment sequences which determined the order to receive TAK-831 400 milligram (mg) film-coated tablets under fasted conditions and TAK-831 400 mg tablet under fed conditions (nutritional drink).
Participants took part in the study at 1 investigative site in the United States from 04 April 2017 to 26 May 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fed state, once on Day 1 of Intervention Period 2. |
| FG001 | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fasted state, once on Day 1 of Intervention Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 |
| |||||||||||||
| Washout Period (at Least 7 Days) |
| |||||||||||||
| Intervention Period 2 |
|
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fed state, once on Day 1 of Intervention Period 2. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. |
| 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 | Cmax: Maximum Observed Plasma Concentration for TAK-831 | The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug (up to Day 23)
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 | TAK-831 400 mg Fasted | TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neurocrine Medical Information | Neurocrine Biosciences | 877-641-3461 | medinfo@neurocrine.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2016 | May 10, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2017 | May 10, 2018 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| TAK-831 400 mg Fed + TAK-831 400 mg Fasted |
TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fasted state, once on Day 1 of Intervention Period 2. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Region of Enrollment | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Weight | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Mean | Standard Deviation | kilogram (kg) |
|
| Height | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Mean | Standard Deviation | centimeter (cm) |
|
| Body Mass Index (BMI) | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Smoking Classification | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Alcohol Classification | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Caffeine Consumption | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Xanthine Consumption | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
| Female Reproductive Status | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Count of Participants | Participants |
|
|
|
|
| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 | The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose |
|
|
|
|
| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 | The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. The PK analysis population where data at specified time points were available. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose |
|
|
|
|
| Secondary | Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) | The safety analysis set included all participants who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | TAK-831 400 mg Fed | TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2. | 0 | 14 | 0 | 14 | 1 | 14 |
Generally, the PI may publish results of the study following the publication of results by the Sponsor.