- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04234672
A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants
A Phase 1 Study to Assess Absolute Bioavailability of TAK-831 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The drug being tested in this study is called TAK-831 (also known as luvadaxistat). The study will determine ABA in Period 1, and the absorption, metabolism, excretion, and mass balance of TAK-831 after single oral administration in Period 2 in healthy adult male participants, by collecting plasma, urine, and feces samples for drug concentration analysis, and plasma, whole blood, urine, and fecal samples for total radioactivity analysis and metabolic profiling.
The study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (absorption, distribution, metabolism, and elimination [ADME] study period). In Period 1 (ABA study period), all participants will receive a single unlabelled oral dose of TAK-831 as tablet and a microdose intravenous infusion of 50 μg (approximately 1 μCi) [14C]TAK-831, followed by a washout period of 8 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 500 mg (approximately 100 μCi) [14C]TAK-831 as an oral suspension.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 65 days including screening period. Participants will be contacted approximately 30 days after the last dose of study drug for a follow-up assessment.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Nebraska
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Lincoln, Nebraska, United States, 68502
- Celerion
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Weighs at least 45 kilogram (kg) and body mass index (BMI) greater than or equal to (>=) 18.0 and less than (˂) 32.0 kilogram per square meter (kg/m^2) at screening.
Exclusion Criteria:
- Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.
- Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
- Estimated creatinine clearance <80 milliliter per minute (mL/min) at screening.
- Has tattoo(s) or scarring at or near the site of intravenous infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator.
- Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
- Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of first dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe (that is weighted annual limit recommended by the International Commission on Radiological Protection [ICRP] of 3000 milli roentgen equivalent man [mrem]).
- Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg
TAK-831 500 mg, tablet, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.
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TAK-831 tablet.
Other Names:
[14C]TAK-831 IV infusion.
[14C]TAK-831 oral suspension.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Period 1: Percent Absolute Bioavailability (%F) for TAK-831
Time Frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
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Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect.
Percent absolute bioavailability, calculated for plasma TAK-831 as [Actual Dose (IV) x AUCinf (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.
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Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
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Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-831 Eliminated in Urine and Feces Combined [Combined Cum%Dose]
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: Total Radioactivity Expressed as Cumulative Amount of [14C]TAK-831 Eliminated in Urine and Feces Combined (Combined CumAe)
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Urine (Cum%Dose [UR])
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Feces (Cum%Dose [Fe])
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-831
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
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Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-831
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-831 in Plasma
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-831
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-831
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: AUCinf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: AUClast: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax)
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
|
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Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
|
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Period 2: AUCinf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: AUClast: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
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Period 2: CLR: Renal Clearance for TAK-831 in Urine
Time Frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-831
Time Frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
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Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
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Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-831 After Oral Administration
Time Frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
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Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
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Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 After Oral Administration
Time Frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
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Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
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Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 After Oral Administration
Time Frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
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Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
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Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-831 After IV Administration
Time Frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
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Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
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Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-831 After Oral Administration
Time Frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
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Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
|
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Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-831 After IV Administration
Time Frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
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Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
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Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-831 After Oral and [14C]TAK-831 After IV Administration in Plasma
Time Frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours for TAK-831 and up to 95 hours for [14C]TAK-831) post-dose
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Day 1 pre-dose and at multiple time points (up to 96.5 hours for TAK-831 and up to 95 hours for [14C]TAK-831) post-dose
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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time Frame: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)
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An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
A TEAE is defined as an AE with an onset that occurs after receiving study drug.
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From first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)
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Number of Participants With TEAEs Related to Electrocardiogram (ECG)
Time Frame: Up to Day 14
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The ECG parameters were considered TEAEs if they were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal physiologic fluctuation).
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Up to Day 14
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Number of Participants With TEAEs Related to Vital Signs
Time Frame: Up to Day 14
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Vital Signs included body temperature, respiratory rate, blood pressure, and heart rate.
Any clinically significant changes from Baseline as assessed by the investigator were reported as TEAEs.
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Up to Day 14
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Number of Participants With TEAEs Related to Laboratory Parameters
Time Frame: Up to Day 14
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The laboratory parameters included parameters of hematology, serum checmistry and urinalysis.
The laboratory parameters were considered TEAEs if their values were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal).
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Up to Day 14
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TAK-831-1008
- U1111-1242-9877 (Registry Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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