First-In-Human Study Of PF-04958242 In Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01159483
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : October 26, 2010
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Brief Summary:
PF-04958242 in single doses will be safe and well tolerated by healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-04958242 Phase 1

Detailed Description:
To test the safety, tolerability and pharmacokinetics of PF-04958242 in healthy volunteers.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: A Phase I, First-In-Human, Randomized, Subject And Investigator-Blind, Sponsor Open, Single Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pf-04958242 In Healthy Adult Volunteers
Study Start Date : August 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: Cohort 1 Drug: PF-04958242
oral PIB, single dose, 0.01 mg, 0.03 mg, 0.1 mg
Experimental: Cohort 2 Drug: PF-04958242

oral PIB, single dose, 0.3 mg, 0.6 mg*, 1.0 mg*

*Unlikely to be administered as expected to exceed exposure limits.

Primary Outcome Measures :
  1. Safety endpoints including physical examinations, neurological examinations, adverse events, clinical laboratory measurements including CK, vital signs and ECGs. [ Time Frame: 3 days ]
  2. Non-compartment plasma pharmacokinetic parameter endpoints include Cmax, Tmax, AUC0-last, AUC0-∞, and when appropriate CL/F, Vz/F and t1/2. [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Urinary pharmacokinetic parameter endpoints include Ae, Ae%, and CLr. [ Time Frame: 3 days ]
  2. DEQ drug-liking/disliking data and DSST psychomotor performance data. [ Time Frame: 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy volunteers, male and female, ages 21-55

Exclusion Criteria:

  • No women of child-bearing potential, no risk factors for seizures, no risk factors for QTc prolongation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01159483

Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01159483     History of Changes
Other Study ID Numbers: B1701001
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: October 2010

Keywords provided by Pfizer: