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NCT04454918 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04454918: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT04454918 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04454918, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
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 \[ADME\]).
Primary Outcome
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.
Interventions
- DRUG TAK-906 Oral Capsule
- DRUG [14C]-TAK-906 Intravenous Infusion
- DRUG [14C]-TAK-906 Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-07-30 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 1 |
What the finished NCT04454918 record still lists
NCT04454918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which TAK-906 Oral Capsule is the first listed.
NCT04454918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04454918 about?
NCT04454918 is a clinical study titled "Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants". 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 ...
What is the current status of trial NCT04454918?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-07-30. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT04454918?
The interventions under investigation include: TAK-906 Oral Capsule (DRUG), [14C]-TAK-906 Intravenous Infusion (DRUG), [14C]-TAK-906 Oral Solution (DRUG).
Who is sponsoring clinical trial NCT04454918?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04454918's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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