A Phase 1 interventional study of PF-04958242 and PF-04958242 in Schizophrenia, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by Biogen · Phase 1, Interventional, and Basic science
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 39 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PF-04958242
Drug: Placebo
PF-04958242 0.05 mg oral solution Q24 hours for 14 days
PF-04958242 0.10 mg oral solution Q24 hours for 14 days
PF-04958242 0.15 mg oral solution Q24 hours for 14 days
PF-04958242 0.25 mg oral solution Q24 hours for 14 days
Placebo oral solution Q24 hours for 14 days
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
Time frame: Day 1-Day 2
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
Time frame: Day 4
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
Time frame: Day 7
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
Time frame: Day 14-Day 18
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
Time frame: Day 14-Day 15
Drug Effect Questionaire Liking scale
Time frame: Day 14
Digit Symbol Substitution Test
Time frame: Day 14
Columbia Suicide Severity Rating Scale
Time frame: Day 0-Day 14
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Biogen