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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001564-35 | EudraCT Number | ||
| U1111-1159-5663 | Registry Identifier | WHO | |
| 14/WA/1087 | Registry Identifier | NRES |
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The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).
The study will consist of 2 parts involving up to 12 healthy male participants. In Part 1, up to 6 participants will receive a single 80 mg dose of [14C]-TAK-385 administered as an oral solution. In Part 2, up to 6 participants will receive a single oral 80 mg dose of TAK-385 administered as two 40 mg tablets and an 80 μg intravenous (into a vein) dose of [14C]-TAK-385 (containing not more than 37.0kBq [1000 nCi] 14C).
This single centre study will take place in the United Kingdom.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: [14C]-TAK-385 | Experimental | [14C]-TAK-385 80 mg, solution, orally, once on Day 1. |
|
| Part 2: TAK-385 + [14C]-TAK-385 IV | Experimental | TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 μg, infusion, intravenous once on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-TAK-385 Oral Solution | Drug | TAK-385 oral radiolabelled solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method. | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
| Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385). | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385 | Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method. | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
| Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385 | Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385). |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Apparent Oral Clearance (CL/F) for TAK-385 | CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham | United Kingdom |
Healthy cohort of male participants were enrolled in this 2 part study, in 1 of 2 treatment groups as follows : Part 1: [14C]-TAK-385 80 milligram (mg); Part 2:TAK-385 80 mg + [14C]-TAK-385 80 microgram (mcg)
Participants took part in the study at 1 investigative site in United Kingdom from 29 September 2014 to 27 October 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: [14C]-TAK-385 | [14C]-TAK-385 80 mg, solution, orally, single dose on Day 1. |
| FG001 | Part 2: TAK-385 + [14C]-TAK-385 | TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis set (SAS) included all participants who were enrolled and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: [14C]-TAK-385 | [14C]-TAK-385 80 mg, solution, orally, single dose on Day 1. |
| BG001 | Part 2: TAK-385 + [14C]-TAK-385 IV | TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method. | Pharmacokinetic (PK) set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Median | Full Range | hours | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (+/- 2) after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: [14C]-TAK-385 | [14C]-TAK-385 80 mg, solution, orally, single dose on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| C561634 | relugolix |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| TAK-385 Tablets |
| Drug |
TAK-385 tablets 2 X 40 mg |
|
| [14C]-TAK-385 Solution for Intravenous Infusion | Drug | TAK-385 intravenous (IV) radiolabelled solution |
|
| Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385 | AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method. | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
| Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) . | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385 | AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method. | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
| Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385 | AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385). | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385 | Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method. | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
| Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385 | Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385). | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces | Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC). | Day 1 pre-dose and various time-points (up to Day 288) post-dose |
| Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385 | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | Day 1 pre-dose and various time-points (up to 168hours) post-dose |
| Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385 | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385 | AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose |
| Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | AUC(0-inf) is measure of area under the curve from time 0 to Infinity. | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
| Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385 | AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385 | AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385. | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385 | Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385 | Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: Absolute Bioavailability for the Oral Tablet Formulation | Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385 | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity | Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi). | 0 to 191 hours post-dose |
| Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity | Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi). | 0 to 144 hours post-dose |
| Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose | Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C. | 0 to 191 hours post-dose |
| Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose | Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C. | 0 to 144 hours post-dose |
| Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | Hour 1 post-dose |
| Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | Hour 2 post-dose |
| Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | Hour 4 post-dose |
| Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | Hour 8 post-dose |
| Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | Hour 12 post-dose |
| Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | Hour 24 post-dose |
| Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | Hour 36 post-dose |
| Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | Hour 48 post-dose |
| Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | Hour 72 post-dose |
| Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: Apparent Oral Clearance (CL/F) for TAK-385 | CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 1: Volume of Distribution (Vz/F) for TAK-385 | Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product. | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: Volume of Distribution (Vz/F) for TAK-385 | Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces | Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. | Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dose |
| Part 2: Clearance (CL) for [14C]-TAK-385 | CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi). | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Caffeine Consumption | Number | Participants |
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| Xanthine Consumption | Number | Participants |
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| Smoking Classification | Number | Participants |
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| Alcohol Classification | Number | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Median | Full Range | hours | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385 | Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng eq/mL | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
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| Primary | Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385 | Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385 | AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng eq*hr/mL | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
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| Primary | Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) . | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | nanogram hour per milliliter (ng*hr/mL) | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385 | AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng eq*hr/mL | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
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| Primary | Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385 | AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385 | Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | hours | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
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| Primary | Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385 | Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | hours | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces | Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | percent recovery of radioactivity | Day 1 pre-dose and various time-points (up to Day 288) post-dose |
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| Primary | Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Median | Full Range | hours | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Median | Full Range | hours | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385 | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng eq/mL | Day 1 pre-dose and various time-points (up to 168hours) post-dose |
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| Primary | Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385 | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng/mL | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385 | AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng eq*hr/mL | Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose |
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| Primary | Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | AUC(0-inf) is measure of area under the curve from time 0 to Infinity. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Day 1 pre-dose and various time-points (up to 288 hours) post-dose |
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| Primary | Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385 | AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng eq*hr/mL | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385 | AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385 | Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | hours | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385 | Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | hours | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Primary | Part 2: Absolute Bioavailability for the Oral Tablet Formulation | Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385 | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | percentage bioavailability | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Secondary | Part 1: Apparent Oral Clearance (CL/F) for TAK-385 | CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | L/hr | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Secondary | Part 2: Apparent Oral Clearance (CL/F) for TAK-385 | CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | L/hr | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Secondary | Part 1: Volume of Distribution (Vz/F) for TAK-385 | Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | Liter (L) | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Secondary | Part 2: Volume of Distribution (Vz/F) for TAK-385 | Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | L | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| Secondary | Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces | Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | percent recovery of radioactivity | Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dose |
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| Primary | Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity | Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | percentage of recovered radioactivity | 0 to 191 hours post-dose |
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| Primary | Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity | Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | percentage of recovered radioactivity | 0 to 144 hours post-dose |
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| Primary | Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose | Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | percentage of dose | 0 to 191 hours post-dose |
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| Primary | Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose | Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | percentage of dose | 0 to 144 hours post-dose |
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| Primary | Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Number | percentage of dose | Hour 1 post-dose |
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| Primary | Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Number | percentage of dose | Hour 2 post-dose |
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| Primary | Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Number | percentage of dose | Hour 4 post-dose |
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| Primary | Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Number | percentage of dose | Hour 8 post-dose |
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| Primary | Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Number | percentage of dose | Hour 12 post-dose |
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| Primary | Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Number | percentage of dose | Hour 24 post-dose |
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| Primary | Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Number | percentage of dose | Hour 36 post-dose |
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| Primary | Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Number | percentage of dose | Hour 48 post-dose |
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| Primary | Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose | Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered. | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Number | percentage of dose | Hour 72 post-dose |
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| Secondary | Part 2: Clearance (CL) for [14C]-TAK-385 | CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi). | PK set included all participants in the safety set with at least one measurable plasma concentration. | Posted | Mean | Standard Deviation | L/hr | Day 1 pre-dose and various time-points (up to 168 hours) post-dose |
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| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Part 2: TAK-385 + [14C]-TAK-385 IV | TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1. | 0 | 6 | 1 | 6 |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Micturition disorder | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
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No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
| D007263 |
| Infusions, Parenteral |
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