First-In-Human Study Of PF-04958242 In Healthy Volunteers
PF-04958242 in single doses will be safe and well tolerated by healthy volunteers.
|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|
- 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 ]
- 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 ]
|Study Start Date:||August 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
|Experimental: Cohort 1||
oral PIB, single dose, 0.01 mg, 0.03 mg, 0.1 mg
|Experimental: Cohort 2||
oral PIB, single dose, 0.3 mg, 0.6 mg*, 1.0 mg*
*Unlikely to be administered as expected to exceed exposure limits.
To test the safety, tolerability and pharmacokinetics of PF-04958242 in healthy volunteers.