A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers

A Randomized, Subject And Investigator Blinded, Sponsor Open Placebo Controlled, 2 Way, Crossover Phase 1b Study To Examine The Effects Of PF-04958242 On Ketamine Induced Cognitive Impairment In Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01749098

Enrollment

Registered

2012-12-13

Start date

2012-12-31

Completion date

2014-02-28

Last updated

2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

PF-04958242, ketamine, cognition, healthy volunteers

Brief summary

To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal learning and memory, episodic memory and spatial working memory in healthy volunteers.

Detailed description

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Interventions

DRUGPF-04958242

PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5

DRUGKetamine

At 60 minutes after the 0.25 mg dose of PF-04958242 on Day 5, Ketamine (0.23 mg/kg over 1 minute, followed by a maintenance rate of 0.58 mg/kg/hr for 75 minutes) will be infused.

DRUGPlacebo

Placebo capsule orally administered on Days 1 - 5

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

21 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects 21 - 45 years old. * Able to read and write English as primary language. * Subjects who are willing to comply with study procedures.

Exclusion criteria

* History of any substance abuse or dependence disorder meeting DSM-IV criteria and/or by SCID-NP within the past 12 months, with the exception of nicotine. * Known sensitivity to ketamine * Any history of DSM-IV Axis I psychiatric disorders, determined by SCID-NP interview or diagnoses in the view of the investigator.

Design outcomes

Primary

Measure	Time frame
Test score on the Hopkins Verbal Learning Test - Immediate Recall	Day 5

Secondary

Measure	Time frame
Retrospective rating on the Positive and Negative Syndrome Scale -modified scale'	Day 5
Test score on the CogState N-back test	Day 5
Test score on the CogState Spatial Working memory test	Day 5
Test score on the CogState One Card Learning test	Day 5
Test score on the Hopkins Verbal Learning test - Delayed Recall	Day 5
Test score on the Weschler Digit Span Test	Day 5

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026