A Phase I, Randomized, Subject And Investigator Blind, Sponsor Open, Multiple Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- PF-04958242
- Conditions
- Schizophrenia
- Sponsor
- Biogen
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.
Detailed Description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and/or female subjects of non-child bearing potential Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •History of seizures or of a condition with risk of seizures
- •Pregnant or nursing females, and females of child bearing potential
Arms & Interventions
PF-04958242
Intervention: PF-04958242
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
Time Frame: Day 14-Day 18
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
Time Frame: Day 1-Day 2
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
Time Frame: Day 4
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
Time Frame: Day 7
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
Time Frame: Day 14-Day 15
Secondary Outcomes
- Digit Symbol Substitution Test(Day 14)
- Drug Effect Questionaire Liking scale(Day 14)
- Columbia Suicide Severity Rating Scale(Day 0-Day 14)