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Clinical Trial Details

Trial ID: L7338
Source ID: NCT01807377
Associated Drug: Pf-05175157
Title: Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: PF-05175157|DRUG: Midazolam|OTHER: Placebo|DRUG: Midazolam
Outcome Measures: Primary: Maximum Observed Plasma PF-05175157 Concentration (Cmax), Single Dose, 0 - 10 hrs postdose|Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau), Single Dose, 0 - 10 hrs postdose|Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax), Single Dose, 0 - 10 hrs postdose|Maximum Observed Plasma PF-05175157 Concentration (Cmax), Steady State, 0 - 48 hours postdose|Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157, Steady State, 0 - 48 hours postdose|Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax), Steady State, 0 - 48 hours postdose|Apparent Oral Clearance of PF-05175157 (CL/F), 0 - 48 hours postdose|Accumulation Ratio of PF-05175157 (Rac), 0 - 10 hours postdose|Plasma Decay Half-Life of PF-05175157 (t1/2), 0 - 48 hours postdose|Apparent Volume of Distribution of PF-05175157 (Vz/F), 0 - 48 hours postdose|Urinary Recovery for PF-05175157 (AE24), Amount of PF-05175157 recovered in urine over 24 hours, 0 - 24 hours postdose|Renal Clearance for PF-05175157 (CLr), 0 - 24 hours post dose|Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)], 0 - 48 hours postdose|Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)], 0 - 48 hours postdose|Maximum Observed Plasma Concentration for midazolam (Cmax), 0 - 48 hours postdose|Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax), 0 - 48 hours post dose|Plasma Decay Half-Life of midazolam (t1/2), 0 - 48 hours postdose|Fasting triglycerides, 14 days|Total cholesterol, 14 days|LDL cholesterol, 14 days|HDL cholesterol, 14 days |
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 15
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2013-04
Completion Date: 2013-08
Results First Posted:
Last Update Posted: 2013-09-17
Locations: Pfizer Investigational Site, Chula Vista, California, 91911, United States
URL: https://clinicaltrials.gov/show/NCT01807377

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