Celerion
Lincoln, Nebraska, 68502, United States
NCT Number: NCT04833049
The aim of this study is to understand how TAK-994 is processed by the body.
This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994.
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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-994. TAK-994 is being tested in healthy male participants. This study will characterize how TAK -994 is absorbed, metabolize, excreted by the body, after single oral administration by collecting plasma, urine, and feces samples for testing.
The study will enroll approximately 6 participants. The study consists of 2 parts: Part A and Part B.
In Part A, all participants will receive TAK-994 as tablet and [14C]TAK-994 as intravenous infusion. In Part B, all participants will receive a single dose of [14C]TAK-994 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 67 days, including a 28-day screening period plus approximately 30 days for follow up.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TAK-994 tablet.
[14C]TAK-994 intravenous infusion.
[14C]TAK-994 oral suspension.
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Takeda
Industry
A Phase 1 Study to Assess Absolute Bioavailability of TAK-994 and to Characterize Mass Balance, Pharmacokinetics, Absorption, Metabolism, and Excretion of [14C]TAK-994 in Male Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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