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Clinical Trial Details

Trial ID: L6216
Source ID: NCT01757756
Associated Drug: Pf-05175157
Title: Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus|Diabetes Mellitus, Type 2|Glucose Metabolism Disorders
Interventions: DRUG: Pf-05175157|DRUG: placebo|DRUG: midazolam
Outcome Measures: Primary: Maximum Observed Plasma Concentration (Cmax), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose|Area Under the Curve from Time Zero to end of dosing interval (AUCtau), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose|Time to Reach Maximum Observed Plasma Concentration (Tmax), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose|Maximum Observed Plasma Concentration (Cmax), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose|Time to Reach Maximum Observed Plasma Concentration (Tmax), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose|Area Under the Curve from Time Zero to end of dosing interval (AUCtau), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose|Plasma Decay Half-Life (t1/2), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose|Apparent Volume of Distribution (Vz/F), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose|Apparent Oral Clearance (CL/F), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose|Accumulation Ratio (Rac), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose|Ae,tau, 0-12 hr|Ae%, 0-12 hr|Clr, 0-12 hr|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)], 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours|Maximum Observed Plasma Concentration (Cmax), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours|Time to Reach Maximum Observed Plasma Concentration (Tmax), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours|Plasma Decay Half-Life (t1/2), 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)], 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours|fasting triglycerides, 14 days|fasting LDL-cholesterol, 14 days|fasting total cholesterol, 14 days|fasting HDL cholesterol, 14 days |
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2012-10
Completion Date: 2012-11
Results First Posted:
Last Update Posted: 2012-12-31
Locations: Pfizer Investigational Site, South Miami, Florida, 33143, United States
URL: https://clinicaltrials.gov/show/NCT01757756

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D195 Midazolam small molecule DB00683 Details