A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Pfizer
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
Study Overview
Brief Summary
- To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
- To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.
Detailed Description
Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.
On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers OR subjects with kidney impairment
Exclusion Criteria
- •Receiving hemodialysis
- •clinically significant or unstable medical disease other than kidney disease
Arms & Interventions
Group 1-Normal
Intervention: PD 0332334 (Drug)
Group 2-Mild
Intervention: PD 0332334 (Drug)
Group 3-Moderate
Intervention: PD 0332334 (Drug)
Group 4-Severe
Intervention: PD 0332334 (Drug)
Outcomes
Primary Outcomes
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
Time Frame: 1 day
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)
Time Frame: 5 days
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),
Time Frame: 5 to 17 days depending on cohort
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),
Time Frame: 5 to 17 days depending on cohort
Secondary Outcomes
- Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs(5 to 17 days)