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NCT04992442 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04992442 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 6 participants.
The verdict
NCT04992442, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie \[μCi\]) \[14C\]TAK-935 and a single oral administration of 3×100 mg milligram (mg) TAK-935 tablets in Treatment Period 1, and to assess the mass balance, characterize the pharmacokinetics (PK) of TAK-935 and metabolite \[M-I (N-oxide)\] in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral administration of 300 mg (approximately 100 μCi) \[14C\]TAK-935 in Treatment Period 2.
Interventions
- DRUG TAK-935 Oral Tablet
- DRUG [14C]TAK-935 IV Infusion
- DRUG [14C]TAK-935 Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2020-08-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04992442
The ClinicalTrials.gov registry entry for NCT04992442 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which TAK-935 Oral Tablet is the first listed.
NCT04992442 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04992442 about?
NCT04992442 is a clinical study titled "Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants". The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie \[μCi\]) \[14C\]TAK-935 and a single oral administration of 3×100 mg milligram (mg) TAK-935 tablets in...
What is the current status of trial NCT04992442?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-07-09. Estimated completion is 2020-08-18.
What interventions are being tested in trial NCT04992442?
The interventions under investigation include: TAK-935 Oral Tablet (DRUG), [14C]TAK-935 IV Infusion (DRUG), [14C]TAK-935 Oral Solution (DRUG).
Who is sponsoring clinical trial NCT04992442?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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