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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749098
• Other study ID #: B1701013
• Status: Completed
• Phase: Phase 1
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: November 2019
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Schizophrenia

Intervention

Drug:
• PF-04958242
PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5
• Ketamine
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.
• Placebo
Placebo capsule orally administered on Days 1 - 5
• Ketamine
At 60 minutes after Placebo 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.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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