Celerion
Lincoln, Nebraska, 68502, United States
NCT Number: NCT04234672
The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) [14C]TAK-831 in Period 2.
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Notify Me19 year–55 year
Male
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TAK-831 tablet.
Other names: Luvadaxistat
[14C]TAK-831 IV infusion.
[14C]TAK-831 oral suspension.
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-831 as [Actual Dose (IV) x AUCinf (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1
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
Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Time frame: Up to Day 14
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).
Time frame: Up to Day 14
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.
Time frame: Up to Day 14
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).
Neurocrine Biosciences
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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