Healthy VolunteersPhase 1NCT02252354
TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study
A Phase 1 study testing [14C]-TAK-385 Oral Solution, TAK-385 Tablets and [14C]-TAK-385 Solution for Intravenous Infusion in people with Healthy Volunteers, run by Takeda at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-TAK-385 Oral Solution, TAK-385 Tablets and [14C]-TAK-385 Solution for Intravenous Infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signs a written, informed consent form prior to the initiation of any study procedures.
- Is a healthy male, aged 18 to 55; inclusive on Day-1.
- Is capable of understanding and complying with protocol requirements.
- Weighs at least 50 kg and has a body mass index (BMI) between 18.0 and 35.0 kg/m^2, inclusive at Screening or Day-1.
- In the opinion of the investigator, is in good healthy condition on the basis of a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood biochemistry, hematology, and serology test and urinalysis at Screening and Day -1.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 90 days after last dose.
Who cannot join
- Has received any investigational compound within 45 days prior to Day -1.
- Has received TAK-385 in a previous clinical study.
- Has a resting systolic blood pressure ≤90 mmHg or ≥140 mmHg and a resting diastolic blood pressure ≤50 mmHg or ≥90 mmHg in supine position at Screening or Day-1.
- QTc (Fridericia's correction) is >450 msec at Screening or at Day -1 as read on the printout of the ECG produced by the electrocardiogram (ECG) equipment and evaluated by the investigator
- Has active liver disease or jaundice, or with alanine aminotransferase (ALT),aspartate aminotransferase (AST), or bilirubin (total bilirubin) >1.5 times the upper limit of normal (ULN) in the clinical laboratory tests at VISIT 1 and 2. The participant has positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) or known history of human immunodeficiency virus (HIV) at Screening.
- Has a resting pulse and heart rate (as read on ECG) <45 beats per minute (bpm) or >100 bpm at Screening or Day -1.
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- Has had an acute, clinically significant illness within 30 days prior to Day -1.
- Has a history or clinical manifestations of significant metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary, cardiovascular,gastrointestinal, neurological, rheumatologic, skin and subcutaneous tissue disorders,infectious, hepatic, renal, urologic, immunologic, psychiatric or mood disorders (including any past history of suicide attempt), or history of lactose intolerance.
- Has a family history of bleeding disorders.
- Has current or recent (within 6 months) history of gastrointestinal disease that would be expected to influence the absorption of drugs (ie, history of malabsorption,esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent heartburn, or any surgical intervention).
- Has irregular defecation patterns (less than one defecation per two days or excessive diarrhea) and/or has a history of changes in bowel habits with daily routine or environment changes.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- Has a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy), thoracic or nonperipheral vascular surgery within 6 months prior to Day - 1.
- Has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to Day 1.
- Has significant cardiovascular disease including, but not limited to, a history of myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, clinically significant abnormal ECGs, New York Heart Association (NYHA) Functional Classification III or IV, or documented cerebrovascular accident within 6 months prior to Day -1.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within 1 year prior to the Screening Visit.
- Has used any tobacco (ie, nicotine) products (including but not limited to cigarettes, pipe, cigar, chewing tobacco, nicotine patch, or nicotine gum) within 6 months prior to Day -1 or is unwilling to abstain from these products for the duration of the study or has a positive carbon monoxide test result at Screening or Day -1.
- Has taken any medications, supplements or food products as described in the Excluded Medications section. A subject has a positive carbon monoxide test result on Day-1.
- Has poor peripheral venous access.
- Is unwilling or unable to comply with the protocol or scheduled appointments
- Is unable to understand verbal and/or written English.
- Is a study site employee, or is an immediate family member (ie, spouse, parent, child, and sibling) of a study site employee, involved in conduct of this study.
- Has received or donated more than 400 mL of blood or blood products within the 45 days preceding the beginning of the study or plans to donate blood during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Centre,Two Part Phase I Mass Balance Study to Assess the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of Orally Administered [14C]-TAK-385 in Healthy Male Subjects
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).
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-TAK-385 Oral Solution, TAK-385 Tablets, [14C]-TAK-385 Solution for Intravenous Infusion
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-TAK-385 Oral SolutionDrug
TAK-385 oral radiolabelled solution
TAK-385 TabletsDrug
TAK-385 tablets 2 X 40 mg
[14C]-TAK-385 Solution for Intravenous InfusionDrug
TAK-385 intravenous (IV) radiolabelled solution
| Study group | Role | What they receive |
|---|---|---|
| Part 1: [14C]-TAK-385 | Experimental | [14C]-TAK-385 80 mg, solution, orally, once on Day 1. Receives: Drug: [14C]-TAK-385 Oral Solution |
| 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. Receives: Drug: TAK-385 Tablets; Drug: [14C]-TAK-385 Solution for Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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) .
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Hour 72 post-dose
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252354
- Sponsor's protocol ID
- TAK-385-1009
- Other IDs
- 2014-001564-35, U1111-1159-5663, 14/WA/1087, 2014
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2014
- Last updated
- 27 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Centre,Two Part Phase I Mass Balance Study to Assess the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of Orally Administered [14C]-TAK-385 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02252354
- Acronym / sponsor ID
- TAK-385-1009
- Conditions
- Healthy Volunteers
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Posted 1 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: [14C]-TAK-385 | Experimental | Drug: [14C]-TAK-385 Oral Solution[14C]-TAK-385 80 mg, solution, orally, once on Day 1. |
| Part 2: TAK-385 + [14C]-TAK-385 IV | Experimental | Drug: TAK-385 Tablets, Drug: [14C]-TAK-385 Solution for Intravenous InfusionTAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 μg, infusion, intravenous once on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signs a written, informed consent form prior to the initiation of any study procedures.
- Is a healthy male, aged 18 to 55; inclusive on Day-1.
- Is capable of understanding and complying with protocol requirements.
- Weighs at least 50 kg and has a body mass index (BMI) between 18.0 and 35.0 kg/m^2, inclusive at Screening or Day-1.
- In the opinion of the investigator, is in good healthy condition on the basis of a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood biochemistry, hematology, and serology test and urinalysis at Screening and Day -1.
Key exclusion criteria (23 listed)
- Has received any investigational compound within 45 days prior to Day -1.
- Has received TAK-385 in a previous clinical study.
- Has a resting systolic blood pressure ≤90 mmHg or ≥140 mmHg and a resting diastolic blood pressure ≤50 mmHg or ≥90 mmHg in supine position at Screening or Day-1.
- QTc (Fridericia's correction) is >450 msec at Screening or at Day -1 as read on the printout of the ECG produced by the electrocardiogram (ECG) equipment and evaluated by the investigator
- Has active liver disease or jaundice, or with alanine aminotransferase (ALT),aspartate aminotransferase (AST), or bilirubin (total bilirubin) >1.5 times the upper limit of normal (ULN) in the clinical laboratory tests at VISIT 1 and 2. The participant has positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) or known history of human immunodeficiency virus (HIV) at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-TAK-385 Oral SolutionTAK-385 oral radiolabelled solution | Drug | Part 1: [14C]-TAK-385 |
| TAK-385 TabletsTAK-385 tablets 2 X 40 mg | Drug | Part 2: TAK-385 + [14C]-TAK-385 IV |
| [14C]-TAK-385 Solution for Intravenous InfusionTAK-385 intravenous (IV) radiolabelled solution | Drug | Part 2: TAK-385 + [14C]-TAK-385 IV |
Primary outcome
Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
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.
Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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).
Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
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.
Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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).
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
Time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
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.
Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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) .
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
Time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
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.
Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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).
Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
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.
Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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).
Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces
Time frame: Day 1 pre-dose and various time-points (up to Day 288) post-dose
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).
Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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.
Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168hours) post-dose
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.
Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385
Time frame: Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose
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.
Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
AUC(0-inf) is measure of area under the curve from time 0 to Infinity.
Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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.
Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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.
Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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.
Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.
Part 2: Absolute Bioavailability for the Oral Tablet Formulation
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
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
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity
Time frame: 0 to 191 hours post-dose
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).
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity
Time frame: 0 to 144 hours post-dose
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).
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose
Time frame: 0 to 191 hours post-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.
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose
Time frame: 0 to 144 hours post-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.
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose
Time frame: 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.
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose
Time frame: 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.
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose
Time frame: 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.
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose
Time frame: 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.
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose
Time frame: 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.
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose
Time frame: 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.
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose
Time frame: 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.
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose
Time frame: 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.
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose
Time frame: 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.
6 secondary outcomes
Part 1: Apparent Oral Clearance (CL/F) for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
Part 2: Apparent Oral Clearance (CL/F) for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
Part 1: Volume of Distribution (Vz/F) for TAK-385
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
Part 2: Volume of Distribution (Vz/F) for TAK-385
Time frame: 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
Time frame: 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
Time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-TAK-385 Oral Solution, TAK-385 Tablets and [14C]-TAK-385 Solution for Intravenous Infusion in people with Healthy Volunteers, run by Takeda at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385 (time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.