Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie \[μCi\]) \[14C\]TAK-935 and a single oral administration of 3×100 mg milligram (mg) TAK-935 tablets in Treatment Period 1, and to assess the mass balance, characterize the pharmacokinetics (PK) of TAK-935 and metabolite \[M-I (N-oxide)\] in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral administration of 300 mg (approximately 100 μCi) \[14C\]TAK-935 in Treatment Period 2.
Detailed description
The drug being tested in this study is called TAK-935 (also known as soticlestat/OV935). The study determines ABA in Treatment Period 1, and the absorption, metabolism, excretion, and mass balance of TAK-935 after single oral administration in Treatment 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 healthy adult male participants. The study is designed to consist of 2 periods: Treatment Period 1 (ABA Study Period) and Treatment Period 2 (Absorption, Distribution, Metabolism, and Elimination \[ADME\] Study Period). In Treatment Period 1, all participants will receive a single unlabelled oral dose of TAK-935 as 3×100 mg tablets and a microdose IV infusion of 50 μg (approximately 1 μCi) \[14C\]TAK-935, followed by a Washout Period of 7 days before the dose in Treatment Period 2. In Treatment Period 2, all participants will receive a single dose of 300 mg (approximately 100 μCi) \[14C\]TAK-935 as an oral solution. 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. This compound was transferred to Takeda and acquired on 29 March 2021. This registration is retrospective due to the transfer of ownership.
Interventions
DRUGTAK-935 Oral Tablet
TAK-935 tablet
DRUG[14C]TAK-935 IV Infusion
\[14C\]TAK-935 IV infusion
DRUG[14C]TAK-935 Oral Solution
\[14C\]TAK-935 oral solution
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Weighs at least 50 kg and body mass index (BMI) ≥18.0 and ˂32.0 kg/m\^2 at Screening Visit. 2. Continuous nonsmoker who has not used nicotine-containing products (including vaping) for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting. 3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the Investigator or designee.
Exclusion criteria
1. History or presence of cataracts or other clinically significant vision disturbances. 2. Abnormal and clinically significant ECG abnormality at Screening visit: * QT interval with Fridericia's correction method (QTcF) \>450 milliseconds (ms) confirmed with one repeat testing. 3. History or presence of gastritis, gastrointestinal tract, gastric bypass surgery, or hepatic disorder or other clinical condition which, in the opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug. 4. Has a risk of suicide according to the Investigator's clinical judgment \[e.g., per Columbia-Suicide Severity Rating Scale (C-SSRS)\] or has made a suicide attempt in the previous year prior to Screening Visit. 5. Positive urine drug or alcohol results at screening or first check-in. 6. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or novel coronavirus 2019 (COVID-19). 7. Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at Screening. 8. Seated HR is lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening Visit. 9. Estimated creatinine clearance \<80 mL/min at Screening Visit. 10. Has tattoo(s) or scarring at or near the site of IV infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator. 11. Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing. 12. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks prior to first dosing. 13. 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 \[i.e., weighted annual limit recommended by the International Commission on Radiological Protection (ICRP) of 3000 milli roentgen equivalent man (mrem)\]. 14. Unable to refrain from or anticipates the use of: 1. Any drug, including prescription and nonprescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study, including the Follow-up Period. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. After the first dose of study drug, ibuprofen (up to 1.2 g per 24 hours) may be administered at the discretion of the Investigator or designee. Milk of Magnesia (i.e., magnesium hydroxide) (≤60 mL per day) may be administered to ensure defecation, at discretion of the Investigator or designee. 2. Any drugs known to be significant inducers of cytochrome P450 (CYP)3A4, CYP2C19 or uridine diphosphate glucuronosyltransferase (UGT), including St. John's Wort, within 28 days prior to the first dosing and throughout the study, including the Follow-up Period. Appropriate sources (e.g., Flockhart Table\^TM) will be consulted to confirm lack of PK/pharmacodynamic interaction with study drug(s). 3. Alcohol 15. 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. 16. Donation of blood or significant blood loss within 56 days prior to the first dosing. 17. Plasma donation within 7 days prior to the first dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Period 1: Percent Absolute Bioavailability (%F) for TAK-935 | Day 1 pre-dose and at multiple time points (up to 48 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-935 as \[Actual Dose (IV) x Area Under the Concentration-time Curve from Time 0 to Infinity {AUCinf} (oral)\] / \[Actual Dose (oral) x AUCinf (IV)\] x 100. |
| Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-935 Excreted in Urine and Feces Combined [Combined Cum%Dose] | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u]) | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f]) | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe) | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u]) | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (Cum%Dose[f]) | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-935 | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-935 | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-935 in Plasma | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935 | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935 | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-935 | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| 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 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: AUC0-inf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: AUC0-t: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Time t | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: AUC0-last: 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 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax) | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| 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 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: AUC0-inf: 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 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: AUC0-t: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to t | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: AUC0-last: 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 120 hours) post-dose in Treatment Period 2 | — |
| Period 2: CLR: Renal Clearance for TAK-935 in Urine | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | Renal clearance (CLr) is the volume of plasma entering the kidney that is completely cleared of drug per unit of time. |
| Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval | 0-12, 12-24, 24-48, 48-72, 72-96, 96-120 hours post-dose in Treatment Period 2 | — |
| Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 0.17, 0.42, 0.75, 1.5, 2.5, 4.5, 8, 12, and 24 hours post-dose in Treatment Period 2 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-935 | Day 1: At the end of infusion (at 15 minutes post dose) in Treatment Period 1 | — |
| Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-935 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | — |
| Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-935 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | — |
| Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | — |
| Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-935 After IV Administration | Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1 | — |
| Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to t After Oral Administration | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | — |
| Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935 After IV Administration | Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1 | — |
| Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-935 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1 | — |
| Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-935 After IV Administration | Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1 | — |
| Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-935 After Oral Administration in Plasma | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | — |
| Period 1: t(1/2)z: Terminal Disposition Half-life for [14C]TAK-935 After IV Administration in Plasma | Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose | — |
| Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u]) After IV Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | — |
| Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f]) After IV Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | — |
| Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe) After IV Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | — |
| Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u]) After IV Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | — |
| Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (%Dose[f]) After IV Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1 | — |
| Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | The metabolic profile of TAK-935 after oral administration of \[14C\]TAK-935 was done to assess the presence of TAK-935 and various metabolites (M1 to M9) in plasma in at least one sample using radiometric detection and/or liquid chromatography mass spectroscopy (LCMS). The presence of any metabolite is indicated as '1' and absence is indicated as '0'. Only categories with value '1' are reported. |
| Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 | The metabolic profile of TAK-935 after oral administration of \[14C\]TAK-935 was done to assess the presence of TAK-935 and various metabolites (M1 to M9) in urine and feces in at least one sample using radiometric detection and/or LCMS. The presence of any metabolite is indicated as '1' and absence is indicated as '0'. Data is reported separately for urine and feces. |
| Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) | From first dose up to 30 days after last dose of study drug (up to approximately 40 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 that is starting or worsening at the time of or after study drug administration. |
| Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | From first dose up to 30 days after last dose of study drug (up to approximately 40 days) | — |
| Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Vital Sign Parameters | From first dose up to 30 days after last dose of study drug (up to approximately 40 days) | Vital Signs included blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and temperature. |
| Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Laboratory Parameters | From first dose up to 30 days after last dose of study drug (up to approximately 40 days) | The laboratory parameters included tests for serum chemistry, hematology, coagulation, and urinalysis. |
Countries
United States
Contacts
STUDY_DIRECTORStudy Director
Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the United States from 09 July 2020 to 18 August 2020.
Pre-assignment details
Healthy male participants were enrolled in this study to receive TAK-935 tablets followed by radio-labelled TAK-935 intravenous (IV) infusion on Day 1 of Treatment Period 1 and radio-labelled TAK-935 oral solution on Day 1 of Treatment Period 2. There was a 7-day Washout Period between the two periods.
Participants by arm
| Arm | Count |
|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg + [14C]TAK-935 300 mg TAK-935 3×100 mg, tablets, orally, once on Day 1, followed by \[14C\]TAK-935 50 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by \[14C\]TAK-935 300 mg (approximately 100 μCi) solution, orally, once on Day 1 of Treatment Period 2. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | TAK-935 300 mg + [14C]TAK-935 50 μg + [14C]TAK-935 300 mg |
|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 14.81 |
| Body Mass Index (BMI) | 27.000 kg/m^2 STANDARD_DEVIATION 3.4142 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 176.5 cm STANDARD_DEVIATION 7.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
| Weight | 84.82 kg STANDARD_DEVIATION 16.899 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Period 1: Percent Absolute Bioavailability (%F) for TAK-935
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-935 as \[Actual Dose (IV) x Area Under the Concentration-time Curve from Time 0 to Infinity {AUCinf} (oral)\] / \[Actual Dose (oral) x AUCinf (IV)\] x 100.
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Population: Pharmacokinetic (PK) Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets and 50 μg IV dose in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: Percent Absolute Bioavailability (%F) for TAK-935 | 12.57 percent absolute bioavailability | Geometric Coefficient of Variation 75.1 |
Primary
Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval
Time frame: 0-12, 12-24, 24-48, 48-72, 72-96, 96-120 hours post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2, with data available for analysis at the given timepoint were evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval | Ae0-12 hours | 268.1 mg eq | Geometric Coefficient of Variation 4.4 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval | Ae12-24 hours | 18.28 mg eq | Geometric Coefficient of Variation 35 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval | Ae24-48 hours | 3.829 mg eq | Geometric Coefficient of Variation 66.2 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval | Ae48-72 hours | 0.3126 mg eq | Geometric Coefficient of Variation 92.8 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval | Ae72-96 hours | 0.1946 mg eq | Geometric Coefficient of Variation 80.6 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval | Ae96-120 hours | 0.2296 mg eq | — |
Primary
Period 2: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935 | 1805 ng*hr/mL | Geometric Coefficient of Variation 40.4 |
Primary
Period 2: AUC0-inf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: AUC0-inf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity | 42890 ng eq*hr/mL | Geometric Coefficient of Variation 21.4 |
Primary
Period 2: AUC0-inf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: AUC0-inf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity | 24420 nanograms (ng) eq*hr/g | Geometric Coefficient of Variation 19.9 |
Primary
Period 2: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-935 | 1638 ng*hr/mL | Geometric Coefficient of Variation 43.1 |
Primary
Period 2: AUC0-last: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: AUC0-last: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration | 40650 ng eq*hr/mL | Geometric Coefficient of Variation 21.9 |
Primary
Period 2: AUC0-last: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: AUC0-last: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration | 22280 ng eq*hr/g | Geometric Coefficient of Variation 20.2 |
Primary
Period 2: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935 | 1547 ng*hr/mL | Geometric Coefficient of Variation 40.8 |
Primary
Period 2: AUC0-t: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Time t
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: AUC0-t: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Time t | 39580 ng eq*hr/mL | Geometric Coefficient of Variation 21.6 |
Primary
Period 2: AUC0-t: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to t
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: The data for TAK-935 concentration in whole blood were not collected therefore AUC0-t cannot be determined and not available.
Primary
Period 2: CLR: Renal Clearance for TAK-935 in Urine
Renal clearance (CLr) is the volume of plasma entering the kidney that is completely cleared of drug per unit of time.
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: CLR: Renal Clearance for TAK-935 in Urine | 6.792 L/hr | Geometric Coefficient of Variation 21.8 |
Primary
Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-935 | 1352 ng/mL | Geometric Coefficient of Variation 61.3 |
Primary
Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration | 17220 ng eq/mL | Geometric Coefficient of Variation 34.4 |
Primary
Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration | 9157 ng eq/g | Geometric Coefficient of Variation 29 |
Primary
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (Cum%Dose[f])
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (Cum%Dose[f]) | 3.058 percentage of dose | Geometric Coefficient of Variation 48.2 |
Primary
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u])
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u]) | 94.81 percentage of dose | Geometric Coefficient of Variation 1.4 |
Primary
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration | 3.655 hr |
Primary
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-935 in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-935 in Plasma | 4.374 hr |
Primary
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration | 3.678 hr |
Primary
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-935 | 0.42 hours (hr) |
Primary
Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) | 0.599 hr |
Primary
Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax)
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax) | 0.440 hr |
Primary
Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f])
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f]) | 9.429 mg eq of parent drug | Geometric Coefficient of Variation 48.2 |
Primary
Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe)
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe) | 300.7 mg eq of parent drug | Geometric Coefficient of Variation 0.5 |
Primary
Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u])
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: Analysis Population Description: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u]) | 292.3 mg equivalents (eq) of parent drug | Geometric Coefficient of Variation 1.4 |
Primary
Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-935 Excreted in Urine and Feces Combined [Combined Cum%Dose]
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-935 Excreted in Urine and Feces Combined [Combined Cum%Dose] | 97.55 percentage of dose | Geometric Coefficient of Variation 0.5 |
Primary
Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma
Time frame: 0.17, 0.42, 0.75, 1.5, 2.5, 4.5, 8, 12, and 24 hours post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Number analyzed are the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 0.17 Hour | 0.5881 ratio | Standard Deviation 0.065712 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 0.42 Hour | 0.5440 ratio | Standard Deviation 0.054836 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 0.75 Hour | 0.5561 ratio | Standard Deviation 0.026316 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 1.5 Hours | 0.5361 ratio | Standard Deviation 0.025054 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 2.5 Hours | 0.5934 ratio | Standard Deviation 0.0522 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 4.5 Hours | 0.5823 ratio | Standard Deviation 0.038252 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 8 Hours | 0.5647 ratio | Standard Deviation 0.046592 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 12 Hours | 0.6960 ratio | Standard Deviation 0.16172 |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma | 24 Hours | 1.036 ratio | — |
Secondary
Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
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 that is starting or worsening at the time of or after study drug administration.
Time frame: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Population: Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Period 1 and Period 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) | 0 percentage of participants |
| [14C]TAK-935 300 mg (Feces) | Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) | 16.7 percentage of participants |
Secondary
Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
Time frame: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Population: Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for this outcome measure was collected and reported for Period 1 and Period 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | 0 percentage of participants |
| [14C]TAK-935 300 mg (Feces) | Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | 0 percentage of participants |
Secondary
Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Laboratory Parameters
The laboratory parameters included tests for serum chemistry, hematology, coagulation, and urinalysis.
Time frame: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Population: Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for this outcome measure was collected and reported for Period 1 and Period 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Laboratory Parameters | 0 percentage of participants |
| [14C]TAK-935 300 mg (Feces) | Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Laboratory Parameters | 0 percentage of participants |
Secondary
Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Vital Sign Parameters
Vital Signs included blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and temperature.
Time frame: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Population: Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for this outcome measure was collected and reported for Period 1 and Period 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Vital Sign Parameters | 0 percentage of participants |
| [14C]TAK-935 300 mg (Feces) | Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Vital Sign Parameters | 0 percentage of participants |
Secondary
Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-935 After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-935 After IV Administration | 1742 pg eq*hr/mL | Geometric Coefficient of Variation 15.1 |
Secondary
Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 After Oral Administration | 1304 ng*hr/mL | Geometric Coefficient of Variation 69.3 |
Secondary
Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-935 After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-935 After IV Administration | 1713 pg eq*hr/mL | Geometric Coefficient of Variation 15.3 |
Secondary
Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-935 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-935 After Oral Administration | 1268 ng*hr/mL | Geometric Coefficient of Variation 70.3 |
Secondary
Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to t After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to t After Oral Administration | 1250 ng*hr/mL | Geometric Coefficient of Variation 68.6 |
Secondary
Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935 After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935 After IV Administration | 1691 pg eq*hr/mL | Geometric Coefficient of Variation 15.1 |
Secondary
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-935
Time frame: Day 1: At the end of infusion (at 15 minutes post dose) in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-935 | 2472 picograms (pg) eq /mL | Geometric Coefficient of Variation 22.7 |
Secondary
Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-935 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-935 After Oral Administration | 822.8 ng/mL | Geometric Coefficient of Variation 149.6 |
Secondary
Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (%Dose[f]) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (%Dose[f]) After IV Administration | 1.587 percentage of dose | Geometric Coefficient of Variation 76.4 |
Secondary
Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u]) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u]) After IV Administration | 95.17 percentage of dose | Geometric Coefficient of Variation 1.3 |
Secondary
Period 1: t(1/2)z: Terminal Disposition Half-life for [14C]TAK-935 After IV Administration in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: t(1/2)z: Terminal Disposition Half-life for [14C]TAK-935 After IV Administration in Plasma | 1.358 hr |
Secondary
Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-935 After Oral Administration in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-935 After Oral Administration in Plasma | 4.249 hr |
Secondary
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-935 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-935 3×100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-935 After Oral Administration | 1.129 hr |
Secondary
Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f]) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f]) After IV Administration | 0.7988 µg eq | Geometric Coefficient of Variation 76.2 |
Secondary
Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe) After IV Administration | 48.82 µg eq | Geometric Coefficient of Variation 1.4 |
Secondary
Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u]) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received \[14C\]TAK-935 50 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u]) After IV Administration | 48.14 µg eq | Geometric Coefficient of Variation 1.4 |
Secondary
Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935
The metabolic profile of TAK-935 after oral administration of \[14C\]TAK-935 was done to assess the presence of TAK-935 and various metabolites (M1 to M9) in plasma in at least one sample using radiometric detection and/or liquid chromatography mass spectroscopy (LCMS). The presence of any metabolite is indicated as '1' and absence is indicated as '0'. Only categories with value '1' are reported.
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | TAK-935 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | M1 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | M2 | 0 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | M3 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | M4 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | M5 | 0 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | M6 | 0 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | M7 | 0 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | M8 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935 | M9 | 0 sample positive |
Secondary
Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935
The metabolic profile of TAK-935 after oral administration of \[14C\]TAK-935 was done to assess the presence of TAK-935 and various metabolites (M1 to M9) in urine and feces in at least one sample using radiometric detection and/or LCMS. The presence of any metabolite is indicated as '1' and absence is indicated as '0'. Data is reported separately for urine and feces.
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-935 300 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M2 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M5 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M6 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M1 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M7 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M3 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M8 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | TAK-935 | 1 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M9 | 0 sample positive |
| TAK-935 300 mg + [14C]TAK-935 50 μg | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M4 | 1 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M9 | 1 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | TAK-935 | 1 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M1 | 0 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M2 | 1 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M3 | 0 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M4 | 0 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M6 | 0 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M7 | 0 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M8 | 1 sample positive |
| [14C]TAK-935 300 mg (Feces) | Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935 | M5 | 0 sample positive |