PRAHS
Groningen, 9728 NZ, Netherlands
NCT Number: NCT03500224
The purpose of this study is to determine the mass balance, routes of elimination and characterize the metabolic profiles of a single intravenous dose of [14C]-TAK-954, identify major circulating and excreted metabolites. This study will also determine the single-dose PK of total radioactivity, TAK-954 and its metabolites where possible.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
The drug being tested in this study is called TAK-954. This study will assess the mass balance, metabolic profiles and routes of elimination of single intravenous dose of [14C]-TAK-954, and will determine the major circulating and excreted metabolites and single-dose PK of total radioactivity, TAK-954, THRX513466, and THRX 913682 in healthy male participants.
The study will enroll approximately 6 participants. All participants will receive a single dose of [14C]-TAK-954 0.5 mg on Day 1.
This single-center trial will be conducted in Netherlands. The overall time to participate in this study is approximately 6 to 7 weeks. Participants will make a final visit to the clinic 15 days after 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
[14C]-TAK-954 intravenous infusion.
Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.
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
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 264 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Time frame: Baseline up to Day 31
Time frame: Baseline up to Day 15
Millennium Pharmaceuticals, Inc.
Industry
A Phase 1, Open-label, Single Intravenous Infusion Dose Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Adult Male 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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