A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants

Sponsor
Neurocrine Biosciences (Industry)
Overall Status
Completed
CT.gov ID
NCT04234672
Collaborator
Takeda (Industry)
6
Enrollment
1
Location
1
Arm
1.5
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) [14C]TAK-831 in Period 2.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: TAK-831 Oral Tablet
  • Drug: [14C]TAK-831 IV Infusion
  • Drug: [14C]TAK-831 Oral Suspension
Phase 1

Detailed Description

The drug being tested in this study is called TAK-831 (also known as luvadaxistat). The study will determine ABA in Period 1, and the absorption, metabolism, excretion, and mass balance of TAK-831 after single oral administration in Period 2 in healthy adult male participants, by collecting plasma, urine, and feces samples for drug concentration analysis, and plasma, whole blood, urine, and fecal samples for total radioactivity analysis and metabolic profiling.

The study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (absorption, distribution, metabolism, and elimination [ADME] study period). In Period 1 (ABA study period), all participants will receive a single unlabelled oral dose of TAK-831 as tablet and a microdose intravenous infusion of 50 μg (approximately 1 μCi) [14C]TAK-831, followed by a washout period of 8 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 500 mg (approximately 100 μCi) [14C]TAK-831 as an oral suspension.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 65 days including screening period. Participants will be contacted approximately 30 days after the last dose of study drug for a follow-up assessment.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Phase 1 Study to Assess Absolute Bioavailability of TAK-831 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Subjects
Actual Study Start Date :
Feb 17, 2020
Actual Primary Completion Date :
Apr 4, 2020
Actual Study Completion Date :
Apr 4, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg

TAK-831 500 mg, tablet, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.

Drug: TAK-831 Oral Tablet
TAK-831 tablet.
Other Names:
  • Luvadaxistat
  • Drug: [14C]TAK-831 IV Infusion
    [14C]TAK-831 IV infusion.

    Drug: [14C]TAK-831 Oral Suspension
    [14C]TAK-831 oral suspension.

    Outcome Measures

    Primary Outcome Measures

    1. Period 1: Percent Absolute Bioavailability (%F) for TAK-831 [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

      Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-831 as [Actual Dose (IV) x AUCinf (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.

    2. Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-831 Eliminated in Urine and Feces Combined [Combined Cum%Dose] [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    3. Period 2: Total Radioactivity Expressed as Cumulative Amount of [14C]TAK-831 Eliminated in Urine and Feces Combined (Combined CumAe) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    4. Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Urine (Cum%Dose [UR]) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    5. Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Feces (Cum%Dose [Fe]) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    6. Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-831 [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose]

    7. Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-831 [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    8. Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-831 in Plasma [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    9. Period 2: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-831 [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    10. Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-831 [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    11. Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    12. Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    13. Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    14. Period 2: AUCinf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    15. Period 2: AUClast: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    16. Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    17. Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    18. Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    19. Period 2: AUCinf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    20. Period 2: AUClast: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

    21. Period 2: CLR: Renal Clearance for TAK-831 in Urine [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose]

    Secondary Outcome Measures

    1. Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-831 [Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1]

    2. Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-831 After Oral Administration [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

    3. Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 After Oral Administration [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

    4. Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 After Oral Administration [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

    5. Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-831 After IV Administration [Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1]

    6. Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-831 After Oral Administration [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

    7. Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-831 After IV Administration [Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1]

    8. Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-831 After Oral and [14C]TAK-831 After IV Administration in Plasma [Day 1 pre-dose and at multiple time points (up to 96.5 hours for TAK-831 and up to 95 hours for [14C]TAK-831) post-dose]

    9. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [From first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)]

      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 is defined as an AE with an onset that occurs after receiving study drug.

    10. Number of Participants With TEAEs Related to Electrocardiogram (ECG) [Up to Day 14]

      The ECG parameters were considered TEAEs if they were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal physiologic fluctuation).

    11. Number of Participants With TEAEs Related to Vital Signs [Up to Day 14]

      Vital Signs included body temperature, respiratory rate, blood pressure, and heart rate. Any clinically significant changes from Baseline as assessed by the investigator were reported as TEAEs.

    12. Number of Participants With TEAEs Related to Laboratory Parameters [Up to Day 14]

      The laboratory parameters included parameters of hematology, serum checmistry and urinalysis. The laboratory parameters were considered TEAEs if their values were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Weighs at least 45 kilogram (kg) and body mass index (BMI) greater than or equal to (>=) 18.0 and less than (˂) 32.0 kilogram per square meter (kg/m^2) at screening.
    Exclusion Criteria:
    1. Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.

    2. Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.

    3. Estimated creatinine clearance <80 milliliter per minute (mL/min) at screening.

    4. Has tattoo(s) or scarring at or near the site of intravenous infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator.

    5. Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.

    6. Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of first dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe (that is weighted annual limit recommended by the International Commission on Radiological Protection [ICRP] of 3000 milli roentgen equivalent man [mrem]).

    7. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.

    8. Donation of blood or significant blood loss within 56 days prior to the first dosing.

    9. Plasma donation within 7 days prior to the first dosing.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1CelerionLincolnNebraskaUnited States68502

    Sponsors and Collaborators

    • Neurocrine Biosciences
    • Takeda

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Neurocrine Biosciences
    ClinicalTrials.gov Identifier:
    NCT04234672
    Other Study ID Numbers:
    • TAK-831-1008
    • U1111-1242-9877
    First Posted:
    Jan 21, 2020
    Last Update Posted:
    Jun 30, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Neurocrine Biosciences

    Study Results

    Participant Flow

    Recruitment DetailsParticipants took part in the study at 1 investigative site in the United States from 17 Feb 2020 to 04 April 2020.
    Pre-assignment DetailHealthy male participants were enrolled in this study to receive TAK-831 tablets followed by radio-labelled TAK-831 intravenous (IV) infusion on Day 1 of Treatment Period 1 and radio-labelled TAK-831 oral suspension on Day 1 of Treatment Period 2. There was an 8-day washout period between the two periods.
    Arm/Group TitleTAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg
    Arm/Group DescriptionTAK-831 5 X 100 mg tablets, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.
    Period Title: Treatment Period 1 (Day 1)
    STARTED6
    COMPLETED6
    NOT COMPLETED0
    Period Title: Treatment Period 1 (Day 1)
    STARTED6
    COMPLETED6
    NOT COMPLETED0
    Period Title: Treatment Period 1 (Day 1)
    STARTED6
    COMPLETED6
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleTAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg
    Arm/Group DescriptionTAK-831 5 X 100 mg tablets, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.
    Overall Participants6
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.2
    (6.9)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    Male
    6
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    3
    50%
    Not Hispanic or Latino
    3
    50%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    2
    33.3%
    White
    3
    50%
    More than one race
    1
    16.7%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    6
    100%
    Height (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    174.8
    (6.1)
    Weight (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    80.25
    (6.5)
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    26.28
    (1.6)

    Outcome Measures

    1. Primary Outcome
    TitlePeriod 1: Percent Absolute Bioavailability (%F) for TAK-831
    DescriptionBioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-831 as [Actual Dose (IV) x AUCinf (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.
    Time FrameDay 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets and 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.
    Arm/Group TitleTAK-831 500 mg + [14C]TAK-831 50 μg
    Arm/Group DescriptionTAK-831 5 X 100 mg tablets, orally, followed by [14C]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [percent absolute bioavailability]
    17.34
    (31.3)
    2. Primary Outcome
    TitlePeriod 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-831 Eliminated in Urine and Feces Combined [Combined Cum%Dose]
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [percentage of dose]
    88.66
    (3.6)
    3. Primary Outcome
    TitlePeriod 2: Total Radioactivity Expressed as Cumulative Amount of [14C]TAK-831 Eliminated in Urine and Feces Combined (Combined CumAe)
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [mg equivalents (eq) of parent drug]
    472.7
    (3.3)
    4. Primary Outcome
    TitlePeriod 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Urine (Cum%Dose [UR])
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [percentage of dose]
    27.50
    (19.8)
    5. Primary Outcome
    TitlePeriod 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Feces (Cum%Dose [Fe])
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [percentage of dose]
    60.71
    (5.9)
    6. Primary Outcome
    TitlePeriod 2: Cmax: Maximum Observed Plasma Concentration of TAK-831
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
    1243
    (33.2)
    7. Primary Outcome
    TitlePeriod 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-831
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Median (Full Range) [hours (hr)]
    0.799
    8. Primary Outcome
    TitlePeriod 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-831 in Plasma
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Mean (Standard Deviation) [hr]
    10.314
    (6.3900)
    9. Primary Outcome
    TitlePeriod 2: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-831
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]
    4198
    (30.8)
    10. Primary Outcome
    TitlePeriod 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-831
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]
    4171
    (30.8)
    11. Primary Outcome
    TitlePeriod 2: Cmax: Maximum Observed Plasma Radioactivity Concentration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng eq/mL]
    5878
    (11.4)
    12. Primary Outcome
    TitlePeriod 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Median (Full Range) [hr]
    2.005
    13. Primary Outcome
    TitlePeriod 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Mean (Standard Deviation) [hr]
    3.162
    (0.3068)
    14. Primary Outcome
    TitlePeriod 2: AUCinf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng eq*hr/mL]
    31010
    (9.8)
    15. Primary Outcome
    TitlePeriod 2: AUClast: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng eq*hr/mL]
    28860
    (8.8)
    16. Primary Outcome
    TitlePeriod 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng eq/g]
    2881
    (9.2)
    17. Primary Outcome
    TitlePeriod 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax)
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Median (Full Range) [hr]
    2.001
    18. Primary Outcome
    TitlePeriod 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Mean (Standard Deviation) [hr]
    2.580
    (0.3922)
    19. Primary Outcome
    TitlePeriod 2: AUCinf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng eq*hr/g]
    15180
    (13.7)
    20. Primary Outcome
    TitlePeriod 2: AUClast: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng eq*hr/g]
    13420
    (14.2)
    21. Primary Outcome
    TitlePeriod 2: CLR: Renal Clearance for TAK-831 in Urine
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 240 hours) post-dose

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 500 mg
    Arm/Group Description[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [L/hr]
    0.06547
    (38.6)
    22. Secondary Outcome
    TitlePeriod 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-831
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the [14C]TAK-831 50 μg IV infusion in Period 1 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 50 μg
    Arm/Group Description[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [picograms per milliliter (pg/mL)]
    2903
    (26.7)
    23. Secondary Outcome
    TitlePeriod 1: Cmax: Maximum Observed Plasma Concentration for TAK-831 After Oral Administration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
    Arm/Group TitleTAK-831 500 mg
    Arm/Group DescriptionTAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
    1121
    (45.5)
    24. Secondary Outcome
    TitlePeriod 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 After Oral Administration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
    Arm/Group TitleTAK-831 500 mg
    Arm/Group DescriptionTAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.
    Measure Participants6
    Median (Full Range) [hr]
    1.255
    25. Secondary Outcome
    TitlePeriod 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 After Oral Administration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
    Arm/Group TitleTAK-831 500 mg
    Arm/Group DescriptionTAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [nanogram hour/milliliter (ng*hr/mL)]
    3436
    (45.7)
    26. Secondary Outcome
    TitlePeriod 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-831 After IV Administration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the [14C]TAK-831 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 50 μg
    Arm/Group Description[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [pg*hr/mL]
    1992
    (18.1)
    27. Secondary Outcome
    TitlePeriod 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-831 After Oral Administration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
    Arm/Group TitleTAK-831 500 mg
    Arm/Group DescriptionTAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]
    3397
    (46.6)
    28. Secondary Outcome
    TitlePeriod 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-831 After IV Administration
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the [14C]TAK-831 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.
    Arm/Group Title[14C]TAK-831 50 μg
    Arm/Group Description[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
    Measure Participants6
    Geometric Mean (Geometric Coefficient of Variation) [pg*hr/mL]
    1972
    (18.1)
    29. Secondary Outcome
    TitlePeriod 1: t(1/2)z: Terminal Disposition Half-life for TAK-831 After Oral and [14C]TAK-831 After IV Administration in Plasma
    Description
    Time FrameDay 1 pre-dose and at multiple time points (up to 96.5 hours for TAK-831 and up to 95 hours for [14C]TAK-831) post-dose

    Outcome Measure Data

    Analysis Population Description
    PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets and [14C]TAK-831 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.
    Arm/Group TitleTAK-831 500 mg[14C]TAK-831 50 μg
    Arm/Group DescriptionTAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
    Measure Participants66
    Mean (Standard Deviation) [hr]
    12.278
    (6.0291)
    3.815
    (1.0456)
    30. Secondary Outcome
    TitleNumber of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
    DescriptionAn 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 is defined as an AE with an onset that occurs after receiving study drug.
    Time FrameFrom first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)

    Outcome Measure Data

    Analysis Population Description
    Safety Population included all participants who received at least one dose of the study drug. Data is reported as per the treatment received in Treatment Periods 1 and 2.
    Arm/Group TitleTAK-831 500 mg[14C]TAK-831 50 μg[14C]TAK-831 500 mg
    Arm/Group DescriptionTAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants666
    Count of Participants [Participants]
    0
    0%
    0
    NaN
    2
    NaN
    31. Secondary Outcome
    TitleNumber of Participants With TEAEs Related to Electrocardiogram (ECG)
    DescriptionThe ECG parameters were considered TEAEs if they were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal physiologic fluctuation).
    Time FrameUp to Day 14

    Outcome Measure Data

    Analysis Population Description
    Safety Population included all participants who received at least one dose of the study drug and will be included in the safety evaluations. Data is reported as per the treatment received in Treatment Periods 1 and 2.
    Arm/Group TitleTAK-831 500 mg[14C]TAK-831 50 μg[14C]TAK-831 500 mg
    Arm/Group DescriptionTAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants666
    Count of Participants [Participants]
    0
    0%
    0
    NaN
    0
    NaN
    32. Secondary Outcome
    TitleNumber of Participants With TEAEs Related to Vital Signs
    DescriptionVital Signs included body temperature, respiratory rate, blood pressure, and heart rate. Any clinically significant changes from Baseline as assessed by the investigator were reported as TEAEs.
    Time FrameUp to Day 14

    Outcome Measure Data

    Analysis Population Description
    Safety Population included all participants who received at least one dose of the study drug and will be included in the safety evaluations. Data is reported as per the treatment received in Treatment Periods 1 and 2.
    Arm/Group TitleTAK-831 500 mg[14C]TAK-831 50 μg[14C]TAK-831 500 mg
    Arm/Group DescriptionTAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants666
    Count of Participants [Participants]
    0
    0%
    0
    NaN
    0
    NaN
    33. Secondary Outcome
    TitleNumber of Participants With TEAEs Related to Laboratory Parameters
    DescriptionThe laboratory parameters included parameters of hematology, serum checmistry and urinalysis. The laboratory parameters were considered TEAEs if their values were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal).
    Time FrameUp to Day 14

    Outcome Measure Data

    Analysis Population Description
    Safety Population included all participants who received at least one dose of the study drug and will be included in the safety evaluations. Data is reported as per the treatment received in Treatment Periods 1 and 2.
    Arm/Group TitleTAK-831 500 mg[14C]TAK-831 50 μg[14C]TAK-831 500 mg
    Arm/Group DescriptionTAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    Measure Participants666
    Count of Participants [Participants]
    0
    0%
    0
    NaN
    0
    NaN

    Adverse Events

    Time FrameFrom first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days)
    Adverse Event Reporting Description Data is reported as per the treatment received in Periods 1 and 2.
    Arm/Group TitleTAK-831 500 mg[14C]TAK-831 50 μg[14C]TAK-831 500 mg
    Arm/Group DescriptionTAK-831 5 X 100 mg tablets, orally, once on Day 1 of Treatment Period 1.[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
    All Cause Mortality
    TAK-831 500 mg[14C]TAK-831 50 μg[14C]TAK-831 500 mg
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/6 (0%) 0/6 (0%) 0/6 (0%)
    Serious Adverse Events
    TAK-831 500 mg[14C]TAK-831 50 μg[14C]TAK-831 500 mg
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/6 (0%) 0/6 (0%) 0/6 (0%)
    Other (Not Including Serious) Adverse Events
    TAK-831 500 mg[14C]TAK-831 50 μg[14C]TAK-831 500 mg
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/6 (0%) 0/6 (0%) 2/6 (33.3%)
    Eye disorders
    Eye irritation0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Gastrointestinal disorders
    Abdominal discomfort0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Musculoskeletal and connective tissue disorders
    Arthralgia0/6 (0%) 0/6 (0%) 1/6 (16.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Generally, the PI may publish results of the study following the publication of results by the Sponsor.

    Results Point of Contact

    Name/TitleNeurocrine Medical Information
    OrganizationNeurocrine Biosciences
    Phone877-641-3461
    Emailmedinfo@neurocrine.com
    Responsible Party:
    Neurocrine Biosciences
    ClinicalTrials.gov Identifier:
    NCT04234672
    Other Study ID Numbers:
    • TAK-831-1008
    • U1111-1242-9877
    First Posted:
    Jan 21, 2020
    Last Update Posted:
    Jun 30, 2021
    Last Verified:
    Jun 1, 2021