Healthy Volunteers
Conditions
Keywords
Drug therapy
Brief summary
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.
Detailed description
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: * TAK-831 400 mg Fasted + TAK-831 400 mg Fed * TAK-831 400 mg Fed + TAK-831 400 mg Fasted All participants will be asked to take single oral dose of TAK-831 tablet at the same time on Day 1 of each Intervention Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 23 days. Participants will visit the clinic on Day -1 and remained confined until Day 3 of Intervention Period 1 and 2. A washout period of minimum 7 days will be maintained between the doses in each Intervention Period. Participants will make 3 visits to the clinic on Days 4, 6 and 8 on each Intervention Period and will be contacted by telephone 14 days after the last dose of study drug (Day 23) for a follow-up assessment.
Interventions
DRUGTAK-831
TAK-831 film-coated tablet.
Sponsors
Takeda
Neurocrine Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
1. Has received TAK-831 in a previous clinical study. 2. Has poor peripheral venous access. 3. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to first dose of study drug. 4. Has any dietary restrictions or preferences that may interfere with the conduct of the study.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) | Day 1 |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the United States from 04 April 2017 to 26 May 2017.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 8 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout Period (at Least 7 Days) | Positive drug urine screen | 1 | 0 |
Baseline characteristics
| Characteristic | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Total | TAK-831 400 mg Fasted + TAK-831 400 mg Fed |
|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 11.22 | 33.9 years STANDARD_DEVIATION 9.61 | 35.4 years STANDARD_DEVIATION 7.98 |
| Alcohol Classification Current drinker | 5 Participants | 9 Participants | 4 Participants |
| Alcohol Classification Ex-drinker | 0 Participants | 0 Participants | 0 Participants |
| Alcohol Classification Never drunk | 3 Participants | 6 Participants | 3 Participants |
| Body Mass Index (BMI) | 25.9 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.45 | 25.5 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.3 | 24.9 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.17 |
| Caffeine Consumption Caffeine consumption | 7 Participants | 13 Participants | 6 Participants |
| Caffeine Consumption No caffeine consumption | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Female Reproductive Status Not applicable (Male) | 6 Participants | 12 Participants | 6 Participants |
| Female Reproductive Status Post-menopausal | 1 Participants | 1 Participants | 0 Participants |
| Female Reproductive Status Surgically sterile | 1 Participants | 2 Participants | 1 Participants |
| Height | 173.8 centimeter (cm) STANDARD_DEVIATION 7.19 | 172.6 centimeter (cm) STANDARD_DEVIATION 6.71 | 171.3 centimeter (cm) STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 8 Participants | 3 Participants |
| Region of Enrollment United States | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
| Smoking Classification Current smoker | 0 Participants | 1 Participants | 1 Participants |
| Smoking Classification Ex-smoker | 1 Participants | 2 Participants | 1 Participants |
| Smoking Classification Never smoked | 7 Participants | 12 Participants | 5 Participants |
| Weight | 78.6 kilogram (kg) STANDARD_DEVIATION 11.19 | 76.1 kilogram (kg) STANDARD_DEVIATION 10.48 | 73.3 kilogram (kg) STANDARD_DEVIATION 9.65 |
| Xanthine Consumption No xanthine consumption | 1 Participants | 2 Participants | 1 Participants |
| Xanthine Consumption Xanthine consumption | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 1 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-831 400 mg Fasted | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 | 2194.8 h*ng/mL | Geometric Coefficient of Variation 53.1 |
| TAK-831 400 mg Fed | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 | 2465.9 h*ng/mL | Geometric Coefficient of Variation 67.8 |
p-value: 0.274590% CI: [0.929, 1.433]ANOVA
Primary
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Population: The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-831 400 mg Fasted | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 | 2290.8 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 53.1 |
| TAK-831 400 mg Fed | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 | 2535.6 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 58.8 |
p-value: 0.176390% CI: [0.969, 1.298]ANOVA
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Population: The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-831 400 mg Fasted | Cmax: Maximum Observed Plasma Concentration for TAK-831 | 650.04 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 47.7 |
| TAK-831 400 mg Fed | Cmax: Maximum Observed Plasma Concentration for TAK-831 | 865.48 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 53.5 |
p-value: 0.005890% CI: [1.146, 1.574]ANOVA
Secondary
Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-831 400 mg Fasted | Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) | 0 percentage of participants |
| TAK-831 400 mg Fed | Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) | 7.1 percentage of participants |