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NCT02497235 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02497235: Completed Phase 1 study, sponsored by Takeda.
NCT02497235 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02497235, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand \[18F\]MNI-792 and PET imaging and to determine the relationship of occupancy to TAK-935 exposure.
Primary Outcome
CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: total volume of distribution \[VT\] (Baseline) - VT (Day 1) = Occupancy (Day 1) \* (VT \[Baseline\] - non-displaceable volume of distribution \[VND\]), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determ
Interventions
- DRUG TAK-935
- DRUG [18F]MNI-792 (tracer)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT02497235 record still lists
NCT02497235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which TAK-935 is the first listed.
NCT02497235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02497235 about?
NCT02497235 is a clinical study titled "A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935". The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand \[18F\]MNI-792 and PET imaging and to determine the relationship of occupancy to TAK-...
What is the current status of trial NCT02497235?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2015-07. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02497235?
The interventions under investigation include: TAK-935 (DRUG), [18F]MNI-792 (tracer) (DRUG).
Who is sponsoring clinical trial NCT02497235?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02497235's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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