Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to determine ABA of TAK-906 following single oral (capsule) administration of 50 milligram (mg) of TAK-906 and single intravenous (IV) microtracer dose administration of 100 microgram (μg) (approximately 1 microcurie \[μCi\]) of \[14C\]-TAK-906 in Period 1 (ABA), and to determine the mass balance of TAK-906 in urine and feces following a single oral (solution) administration of 50 mg (approximately 100 μCi) of \[14C\]-TAK-906 in Period 2 (absorption, distribution, metabolism, and elimination \[ADME\]).
Detailed description
The drug being tested in this study is called TAK-906. The study will determine ABA in Period 1, and ADME, and mass balance of TAK-906 after single oral administration in Period 2 in healthy adult male participants. Plasma and urine samples will be collected for PK determination; plasma, whole blood, urine, and feces samples will be collected for total radioactivity (TRA) determination; and plasma, urine, and feces samples will be collected to characterize the metabolite profiles of TAK-906. The study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1 (ABA study period), all participants will receive single unlabeled oral 50 mg dose of TAK-906 as capsule followed by microdose of 100 μg (approximately 1 μCi) \[14C\]-TAK-906 as intravenous infusion followed by a washout period of at least 7 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 50 mg (approximately 100 μCi) \[14C\]-TAK-906 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.
Interventions
DRUGTAK-906 Oral Capsule
TAK-906 capsule.
DRUG[14C]-TAK-906 Intravenous Infusion
\[14C\]-TAK-906 intravenous infusion.
DRUG[14C]-TAK-906 Oral Solution
\[14C\]-TAK-906 oral solution.
Sponsors
Millennium Pharmaceuticals, Inc.
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. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study. 2. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (˂) 30.0 kilogram per square meter (kg/m\^2) at screening.
Exclusion criteria
1. QT interval corrected for heart rate using Fridericia's formula (QTcF) interval is greater than (\>) 450 millisecond (msec) or Electrocardiogram (ECG) findings are deemed abnormal with clinical significance by the Investigator or designee at screening. 2. Estimated creatinine clearance less than (\<) 90 milliliter per minute (mL/min) at screening. 3. Has tattoo(s) or scarring at or near the site of intravenous (IV) infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator. 4. Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing. 5. 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 last 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 \[mrem\]). 6. 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. 7. Donation of blood or significant blood loss within 56 days prior to the first dosing. 8. Plasma donation within 7 days prior to the first dosing. 9. Unable to refrain from or anticipates the use of: * Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Acetaminophen (up to 2 g per 24 hour period) and Milk of Magnesia® (that is, magnesium hydroxide \[less than or equal to (\<=) 60 mL per day after Day 3 in Period 1 and after Day 8 in Period 2\]) may be permitted during the study, only after dosing, if necessary to treat adverse events (AEs). Additional administration of Milk of Magnesia® may be administered on other days at discretion of the Investigator. * Any drugs known to significantly affect the absorption, distribution, metabolism or elimination of TAK-906 within 28 days prior to the first dosing and throughout the study. Appropriate sources (example, Flockhart Table TM) will be consulted to confirm lack of PK/pharmacodynamics interaction with study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Period 2: Cum%Dose (UR): Cumulative Percentage of Total Radioactivity Excreted in Urine for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2 | — |
| Period 2: Cum%Dose (FE): Cumulative Percentage of Total Radioactivity Excreted in Feces for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2 | — |
| Period 1: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906 | Day 1 pre-dose and at multiple time points (up to 96 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 for plasma TAK-906, calculated as geometric least squares mean ratio: \[Actual Dose (IV) x AUC∞ (oral)\] / \[Actual Dose (oral) x AUC∞ (IV)\] multiplied (x) 100, where AUC∞ for IV infusion was normalized to a 50 mg dose. |
| Period 2: Combined Cum%Dose: Cumulative Combined Percent of Total Radioactivity Excreted in Urine and Feces for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-906 and Metabolite (M23) After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1 |
| Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1 |
| Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1 |
| Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1 |
| Period 1: t(1/2)z : Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1 |
| Period 1: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1 |
| Period 1: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1 |
| Period 1: Ceoi: Plasma Total Radioactivity Concentration at the End of Infusion for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 1: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 1: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 1: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 1: CL: Total Clearance for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 1: Vss: Volume of Distribution During the Terminal Disposition Phase for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 1: t(1/2)z: Terminal Disposition Phase Half-life for [14C]-TAK-906 | Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1 |
| Period 2: Cmax: Maximum Observed Plasma Concentration for TAK-906 and M23 After Oral Administration | 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) for TAK-906 and M23 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 |
| Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 |
| Period 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and M23 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 |
| Period 2: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration | 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 for TAK-906 and M23 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 |
| Period 2: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 |
| Period 2: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration | 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 Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration | 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 Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 |
| Period 2: AUCt: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Time of the Last Common Time Point t for [14C]-TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 |
| Period 2: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2 |
| Period 2: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration | 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 Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration | 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 Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2 |
| Period 2: Tmax: Time to Reach the Maximum Whole Blood Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2 |
| Period 2: AUClast: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2 |
| Period 2: AUC∞: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2 |
| Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2 |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the United States from 30 July 2020 to 29 September 2020.
Pre-assignment details
Healthy male participants were enrolled in this study to receive TAK-906 capsule followed by radio-labelled TAK-906 intravenous (IV) infusion on Day 1 of Treatment Period 1 and radio-labelled TAK-906 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-906 50 mg + [14C]-TAK-906 100 μg + [14C]-TAK-906 50 mg TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 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-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | TAK-906 50 mg + [14C]-TAK-906 100 μg + [14C]-TAK-906 50 mg |
|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 8.04 |
| Body Mass Index (BMI) | 26.408 kg/m^2 STANDARD_DEVIATION 2.9179 |
| 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 | 181.7 cm STANDARD_DEVIATION 8.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 5 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
| Weight | 87.30 kg STANDARD_DEVIATION 13.242 |
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 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Period 1: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906
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 for plasma TAK-906, calculated as geometric least squares mean ratio: \[Actual Dose (IV) x AUC∞ (oral)\] / \[Actual Dose (oral) x AUC∞ (IV)\] multiplied (x) 100, where AUC∞ for IV infusion was normalized to a 50 mg dose.
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Population: Pharmacokinetic (PK) Set 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-906 50 mg capsules followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion in Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906 | 9.12 percent absolute bioavailability |
Primary
Period 2: Combined Cum%Dose: Cumulative Combined Percent of Total Radioactivity Excreted in Urine and Feces for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Combined Cum%Dose: Cumulative Combined Percent of Total Radioactivity Excreted in Urine and Feces for [14C]-TAK-906 | 96.65 percentage of dose | Geometric Coefficient of Variation 1.7 |
Primary
Period 2: Cum%Dose (FE): Cumulative Percentage of Total Radioactivity Excreted in Feces for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Cum%Dose (FE): Cumulative Percentage of Total Radioactivity Excreted in Feces for [14C]-TAK-906 | 94.44 percentage of dose | Geometric Coefficient of Variation 1.9 |
Primary
Period 2: Cum%Dose (UR): Cumulative Percentage of Total Radioactivity Excreted in Urine for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Cum%Dose (UR): Cumulative Percentage of Total Radioactivity Excreted in Urine for [14C]-TAK-906 | 2.162 percentage of dose | Geometric Coefficient of Variation 21.8 |
Secondary
Period 1: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 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-906 50 mg + [14C]-TAK-906 100 μg | Period 1: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 | 1.976 ng eq*hr/mL | Geometric Coefficient of Variation 14.2 |
Secondary
Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for [14C]-TAK-906 | 0.3908 percentage of AUC | Geometric Coefficient of Variation 42.6 |
Secondary
Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Population: PK Set 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-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration | TAK-906 | 0.6598 percentage of AUC | Geometric Coefficient of Variation 58.5 |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 4.288 percentage of AUC | Geometric Coefficient of Variation 67.7 |
Secondary
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 | 1549 pg*hr/mL | Geometric Coefficient of Variation 10.7 |
Secondary
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Population: PK Set 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-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration | TAK-906 | 78.62 ng*hr/mL | Geometric Coefficient of Variation 24.5 |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 6.185 ng*hr/mL | Geometric Coefficient of Variation 37.3 |
Secondary
Period 1: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 | 2.047 ng eq*hr/mL | Geometric Coefficient of Variation 14.3 |
Secondary
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]-TAK-906 | 3795 picograms (pg)/mL | Geometric Coefficient of Variation 14.1 |
Secondary
Period 1: Ceoi: Plasma Total Radioactivity Concentration at the End of Infusion for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: Ceoi: Plasma Total Radioactivity Concentration at the End of Infusion for [14C]-TAK-906 | 3.529 nanogramequivalents/milliliter(ng eq/mL) | Geometric Coefficient of Variation 18.5 |
Secondary
Period 1: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Population: PK Set 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-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration | 631.3 L/hr | Geometric Coefficient of Variation 24.2 |
Secondary
Period 1: CL: Total Clearance for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: CL: Total Clearance for [14C]-TAK-906 | 57.55 L/hr | Geometric Coefficient of Variation 11.8 |
Secondary
Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-906 and Metabolite (M23) After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Population: PK Set 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-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-906 and Metabolite (M23) After Oral Administration | TAK-906 | 29.72 ng/mL | Geometric Coefficient of Variation 49.2 |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-906 and Metabolite (M23) After Oral Administration | Metabolite (M23) | 2.293 ng/mL | Geometric Coefficient of Variation 50.4 |
Secondary
Period 1: t(1/2)z: Terminal Disposition Phase Half-life for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: t(1/2)z: Terminal Disposition Phase Half-life for [14C]-TAK-906 | 1.196 hr | Geometric Coefficient of Variation 21.2 |
Secondary
Period 1: t(1/2)z : Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Population: PK Set 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-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: t(1/2)z : Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration | TAK-906 | 3.892 hours (hr) | Geometric Coefficient of Variation 73.1 |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: t(1/2)z : Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 1.722 hours (hr) | Geometric Coefficient of Variation 24.1 |
Secondary
Period 1: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 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-906 50 mg + [14C]-TAK-906 100 μg | Period 1: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906 | 10.847 hr | Geometric Coefficient of Variation 137.1 |
Secondary
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Population: PK Set 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-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration | TAK-906 | 1.750 hour (hr) |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 1.750 hour (hr) |
Secondary
Period 1: Vss: Volume of Distribution During the Terminal Disposition Phase for [14C]-TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Population: PK Set 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 \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: Vss: Volume of Distribution During the Terminal Disposition Phase for [14C]-TAK-906 | 33.04 Liters | Geometric Coefficient of Variation 14.2 |
Secondary
Period 1: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Population: PK Set 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-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 1: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration | 3545 Liters | Geometric Coefficient of Variation 78.3 |
Secondary
Period 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the given category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and M23 After Oral Administration | TAK-906 | 49.40 ng*hr/mL | Geometric Coefficient of Variation 18.6 |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 2.490 ng*hr/mL | Geometric Coefficient of Variation 50.1 |
Secondary
Period 2: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 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-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration | 144.3 ng eq*hr/mL | Geometric Coefficient of Variation 19 |
Secondary
Period 2: AUC∞: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 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-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUC∞: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration | 87.25 ng eq*hr/mL | Geometric Coefficient of Variation 13.8 |
Secondary
Period 2: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the given category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration | TAK-906 | 3.993 percentage of AUC | Geometric Coefficient of Variation 96.7 |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 8.013 percentage of AUC | Geometric Coefficient of Variation 50 |
Secondary
Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration | TAK-906 | 46.54 ng*hr/mL | Geometric Coefficient of Variation 23.5 |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 2.111 ng*hr/mL | Geometric Coefficient of Variation 47.7 |
Secondary
Period 2: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration | 135.5 ng eq*hr/mL | Geometric Coefficient of Variation 20.2 |
Secondary
Period 2: AUClast: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUClast: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration | 83.17 ng eq*hr/mL | Geometric Coefficient of Variation 13.1 |
Secondary
Period 2: AUCt: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Time of the Last Common Time Point t for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: AUCt: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Time of the Last Common Time Point t for [14C]-TAK-906 After Oral Administration | 109.0 ng eq*hr/mL | Geometric Coefficient of Variation 25.6 |
Secondary
Period 2: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration | 1007 L/hr | Geometric Coefficient of Variation 18.6 |
Secondary
Period 2: Cmax: Maximum Observed Plasma Concentration for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Cmax: Maximum Observed Plasma Concentration for TAK-906 and M23 After Oral Administration | TAK-906 | 26.81 ng/mL | Geometric Coefficient of Variation 31.1 |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Cmax: Maximum Observed Plasma Concentration for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 1.086 ng/mL | Geometric Coefficient of Variation 48.1 |
Secondary
Period 2: Cmax: Maximum Observed Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Cmax: Maximum Observed Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration | 39.85 ng eq/mL | Geometric Coefficient of Variation 33.6 |
Secondary
Period 2: Cmax: Maximum Observed Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Cmax: Maximum Observed Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration | 28.41 ng eq/mL | Geometric Coefficient of Variation 26.7 |
Secondary
Period 2: t(1/2)z: Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the given category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: t(1/2)z: Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration | TAK-906 | 9.993 hr | Geometric Coefficient of Variation 29.4 |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: t(1/2)z: Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 1.833 hr | Geometric Coefficient of Variation 57.9 |
Secondary
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 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-906 50 mg + [14C]-TAK-906 100 μg | Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration | 35.539 hr | Geometric Coefficient of Variation 26.2 |
Secondary
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 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-906 50 mg + [14C]-TAK-906 100 μg | Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration | 16.964 hr | Geometric Coefficient of Variation 112.1 |
Secondary
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration | TAK-906 | 0.500 hr |
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration | Metabolite (M23) | 0.999 hr |
Secondary
Period 2: Tmax: Time to Reach the Maximum Plasma Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Tmax: Time to Reach the Maximum Plasma Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration | 0.758 hr |
Secondary
Period 2: Tmax: Time to Reach the Maximum Whole Blood Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Tmax: Time to Reach the Maximum Whole Blood Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration | 0.504 hr |
Secondary
Period 2: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Population: PK Set 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-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 50 mg + [14C]-TAK-906 100 μg | Period 2: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration | 14430 Liters | Geometric Coefficient of Variation 29.7 |