Celerion
Lincoln, Nebraska, 68502, United States
NCT Number: NCT04454918
The purpose of this study is to determine ABA of TAK-906 following single oral (capsule) administration of 50 milligram (mg) of TAK-906 and single intravenous (IV) microtracer dose administration of 100 microgram (μg) (approximately 1 microcurie [μCi]) of [14C]-TAK-906 in Period 1 (ABA), and to determine the mass balance of TAK-906 in urine and feces following a single oral (solution) administration of 50 mg (approximately 100 μCi) of [14C]-TAK-906 in Period 2 (absorption, distribution, metabolism, and elimination [ADME]).
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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-906. The study will determine ABA in Period 1, and ADME, and mass balance of TAK-906 after single oral administration in Period 2 in healthy adult male participants. Plasma and urine samples will be collected for PK determination; plasma, whole blood, urine, and feces samples will be collected for total radioactivity (TRA) determination; and plasma, urine, and feces samples will be collected to characterize the metabolite profiles of TAK-906.
The study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1 (ABA study period), all participants will receive single unlabeled oral 50 mg dose of TAK-906 as capsule followed by microdose of 100 μg (approximately 1 μCi) [14C]-TAK-906 as intravenous infusion followed by a washout period of at least 7 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 50 mg (approximately 100 μCi) [14C]-TAK-906 as an oral solution.
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-906 capsule.
[14C]-TAK-906 intravenous infusion.
[14C]-TAK-906 oral solution.
Time frame: Day 1 pre-dose and at multiple time points (up to 96 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 for plasma TAK-906, calculated as geometric least squares mean ratio: [Actual Dose (IV) x AUC∞ (oral)] / [Actual Dose (oral) x AUC∞ (IV)] multiplied (x) 100, where AUC∞ for IV infusion was normalized to a 50 mg dose.
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 96 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 95 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 95 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 95 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 95 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 95 hours) post-dose in Treatment Period 1
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2
Millennium Pharmaceuticals, Inc.
Industry
A Phase 1 Study to Assess Absolute Bioavailability of TAK-906 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]-TAK-906 in Healthy 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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