Trial · NCT02332798

Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia

NCT02332798, Phase 1, Completed, Biogen; results first posted 2016-06-14

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia. Trials, record NCT02332798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02332798

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia
NCT number: NCT02332798
Status: Completed
Phases: Phase 1
Enrollment: 39 participants, actual
Lead sponsor: Biogen
Conditions: Schizophrenia
Interventions: PF-04958242, Placebo
First posted: 2015-01-07
Last updated: 2021-10-25
Results first posted: 2016-06-14

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Observed Plasma Concentration (Cmax) (Single Dose)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)
Primary	Cmax (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Primary	Time for Cmax (Tmax) (Single Dose)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)
Primary	Tmax (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	Tmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Primary	Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)
Primary	AUCτ (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	AUCτ steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Primary	Apparent Oral Clearance (CL/F) (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Primary	Apparent Volume of Distribution (Vz/F) (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Primary	Terminal Half-Life (t1/2) (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	Terminal half-life is the time measured for the plasma concentration to decrease by one half. t1/2 steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.
Primary	Observed Accumulation Ratio (Rac) (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1). Rac steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 (ie. X = 14) were presented.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Observed Plasma Concentration (Cmax) (Single Dose)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)	The pharmacokinetic (PK) concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.	nanograms per milliliter (ng/mL)	GEOMETRIC_MEAN
PRIMARY	Cmax (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	The PK concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.	ng/mL	GEOMETRIC_MEAN
PRIMARY	Time for Cmax (Tmax) (Single Dose)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)	The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.	hours	MEDIAN
PRIMARY	Tmax (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.	hours	MEDIAN
PRIMARY	Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)	The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.	nanogramshours per milliliter (ngh/mL)	GEOMETRIC_MEAN
PRIMARY	AUCτ (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.	ng*h/mL	GEOMETRIC_MEAN
PRIMARY	Apparent Oral Clearance (CL/F) (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.	milliliter per minute (mL/min)	GEOMETRIC_MEAN
PRIMARY	Apparent Volume of Distribution (Vz/F) (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.	Liter (L)	GEOMETRIC_MEAN
PRIMARY	Terminal Half-Life (t1/2) (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.	hours	MEAN
PRIMARY	Observed Accumulation Ratio (Rac) (Steady State)	Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21	The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.	Ratio	GEOMETRIC_MEAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group75

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Observed Plasma Concentration (Cmax) (Single Dose)	PF-04958242 0.25 mg	1.920	Geometric Coefficient of Variation 23	nanograms per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) (Single Dose)	PF-04958242 0.475 mg	3.830	Geometric Coefficient of Variation 21	nanograms per milliliter (ng/mL)
Cmax (Steady State)	PF-04958242 0.25 mg	3.174	Geometric Coefficient of Variation 18	ng/mL
Cmax (Steady State)	PF-04958242 0.475 mg	7.139	Geometric Coefficient of Variation 37	ng/mL
Time for Cmax (Tmax) (Single Dose)	PF-04958242 0.25 mg	1.65	Full Range 1.00 to 2.00	hours
Time for Cmax (Tmax) (Single Dose)	PF-04958242 0.475 mg	1.33	Full Range 0.167 to 3.00	hours
Tmax (Steady State)	PF-04958242 0.25 mg	1.65	Full Range 1.00 to 2.00	hours
Tmax (Steady State)	PF-04958242 0.475 mg	1.33	Full Range 0.50 to 4.00	hours
Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)	PF-04958242 0.25 mg	9.570	Geometric Coefficient of Variation 19	nanogramshours per milliliter (ngh/mL)
Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)	PF-04958242 0.475 mg	17.72	Geometric Coefficient of Variation 18	nanogramshours per milliliter (ngh/mL)

1 to 10 of 75Source ClinicalTrials.gov

See all 75 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PF-04958242 0.25 mg	13
Overall Study	STARTED	PF-04958242 0.475 mg	14
Overall Study	STARTED	Placebo	12
Overall Study	COMPLETED	PF-04958242 0.25 mg	12
Overall Study	COMPLETED	PF-04958242 0.475 mg	12
Overall Study	COMPLETED	Placebo	11
Overall Study	NOT COMPLETED	PF-04958242 0.25 mg	1
Overall Study	NOT COMPLETED	PF-04958242 0.475 mg	2
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events99

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Tinnitus	Ear and labyrinth disorders	PF-04958242 0.25 mg	0	13
other	Tinnitus	Ear and labyrinth disorders	PF-04958242 0.475 mg	0	14
other	Tinnitus	Ear and labyrinth disorders	Placebo	1	12
other	Eye pain	Eye disorders	PF-04958242 0.25 mg	0	13
other	Eye pain	Eye disorders	PF-04958242 0.475 mg	1	14
other	Eye pain	Eye disorders	Placebo	0	12
other	Abdominal pain	Gastrointestinal disorders	PF-04958242 0.25 mg	0	13
other	Abdominal pain	Gastrointestinal disorders	PF-04958242 0.475 mg	2	14
other	Abdominal pain	Gastrointestinal disorders	Placebo	0	12
other	Constipation	Gastrointestinal disorders	PF-04958242 0.25 mg	1	13

1 to 10 of 99Source ClinicalTrials.gov

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Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PF-04958242 0.25 mg
Total, all-cause mortality	PF-04958242 0.475 mg
Total, all-cause mortality	Placebo
Total, other adverse events	PF-04958242 0.25 mg	10	13
Total, other adverse events	PF-04958242 0.475 mg	9	14
Total, other adverse events	Placebo	4	12
Total, serious adverse events	PF-04958242 0.25 mg	0	13
Total, serious adverse events	PF-04958242 0.475 mg	0	14
Total, serious adverse events	Placebo	0	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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