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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01159483
First received: July 7, 2010
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

PF-04958242 in single doses will be safe and well tolerated by healthy volunteers.


Condition Intervention Phase
Healthy
Drug: PF-04958242
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety endpoints including physical examinations, neurological examinations, adverse events, clinical laboratory measurements including CK, vital signs and ECGs. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary pharmacokinetic parameter endpoints include Ae, Ae%, and CLr. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • DEQ drug-liking/disliking data and DSST psychomotor performance data. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159483

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01159483     History of Changes
Other Study ID Numbers: B1701001
Study First Received: July 7, 2010
Last Updated: October 25, 2010
Health Authority: Singapore: Institutional Review Board

Keywords provided by Pfizer:
safety
tolerability
pharmacokinetics

ClinicalTrials.gov processed this record on April 17, 2014