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NCT02228395 · ClinicalTrials.gov registry record · Phase 1
Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02228395: Completed Phase 1 study, sponsored by Biogen.
NCT02228395 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02228395, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers
Primary Outcome
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific
Interventions
- DRUG Placebo
- DRUG PF-04958242
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-09-22 |
| Est. Completion | 2014-11-13 |
| Phase | Phase 1 |
What the finished NCT02228395 record still lists
NCT02228395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02228395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02228395 about?
NCT02228395 is a clinical study titled "Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers". This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers
What is the current status of trial NCT02228395?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2014-09-22. Estimated completion is 2014-11-13.
What interventions are being tested in trial NCT02228395?
The interventions under investigation include: Placebo (DRUG), PF-04958242 (DRUG).
Who is sponsoring clinical trial NCT02228395?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02228395's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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