Clinical Trial Details
| Trial ID: | L3410 |
| Source ID: | NCT01247896 |
| Associated Drug: | Pf-05190457 |
| Title: | Single Dose Escalation Study of PF-05190457 in Healthy Volunteers |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type II |
| Interventions: | DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: PF-05190457|DRUG: Placebo |
| Outcome Measures: | Primary: Safety and tolerability of PF-05190457 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements, 8 weeks|The single dose PK of PF-05190457 will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit, 48 hour | Secondary: PK of PF-05190457 in the fed condition will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2),, 48 hour|Gastric half-emptying time (GET½), the duration of the lag phase (Tlag), gastric emptying coefficient (GEC), Day 1 for Periods 1 and 2, for Cohort 3. |
| Sponsor/Collaborators: | Sponsor: Pfizer |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 26 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2010-12 |
| Completion Date: | 2011-06 |
| Results First Posted: | |
| Last Update Posted: | 2011-07-06 |
| Locations: | Pfizer Investigational Site, Bruxelles, B-1070, Belgium |
| URL: | https://clinicaltrials.gov/show/NCT01247896 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|