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Clinical Trial Details

Trial ID: L6659
Source ID: NCT01396161
Associated Drug: Pf-05175157 Or Placebo
Title: A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01396161/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: PF-05175157 or Placebo|DRUG: PF-05175157 or Placebo|DRUG: PF-05175157 or Placebo|DRUG: PF-05175157 or Placebo|DRUG: PF-05175157 or Placebo
Outcome Measures: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category., 2 weeks | Secondary: Maximum Observed Plasma Concentration (Cmax), Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Time to Reach Maximum Observed Plasma Concentration (Tmax), Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau), Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC), Rˇac for the AUC is defined as AUC (τ, single dose \[ss\]) / AUC (τ, multiple dose \[sd\])., Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Renal Clearance (CLr), CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval., Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Plasma Decay Half-Life (t1/2), Plasma decay half-life is the time measured for the plasma concentration to decrease by one half., Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Urinary Recovery, Percentage of PF-05175157 excreted unchanged in urine over the dosing interval., Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 64
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: |Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-07
Completion Date: 2012-02
Results First Posted: 2016-11-06
Last Update Posted: 2016-11-06
Locations: Miami Research Associates, South Miami, Florida, 33143, United States|MRA Clinical Research, South Miami, Florida, 33143, United States|Pulmonary Physicians of South Florida, South Miami, Florida, 33143, United States
URL: https://clinicaltrials.gov/show/NCT01396161