Clinical Trial Details
| Trial ID: | L3069 |
| Source ID: | NCT01427257 |
| Associated Drug: | Single Dose Pb1023 |
| Title: | Pharmacokinetic Profile of Two Formulations of PB1023 Following Single Subcutaneous Injection in Subjects With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Single Dose PB1023|DRUG: Single Dose PB1023|DRUG: Single Dose PB1023 |
| Outcome Measures: | Primary: Pharmacokinetics, The pharmacokinetic profile of two formulations of PB1023 will be compared. The following parameters will be evaluated: t1/2, AUC(inf), AUC(0-t), Tmax, Cmax, Elimination Rate Constant, Clearance and Distribution., For each dosing period: Pre-dose, 1, 4, 8, 12 hours, 1, 2, 3, 4, 7 and 10 days post-dose | Secondary: Safety/Tolerability, Safety will be evaluated by analyses of incidence of adverse events of interest (possibly related to the class of drug) and other adverse events. Vital signs, ECGs and safety laboratory parameters will also be presented., 42 Days |
| Sponsor/Collaborators: | Sponsor: PhaseBio Pharmaceuticals Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 10 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-02 |
| Completion Date: | 2012-09 |
| Results First Posted: | |
| Last Update Posted: | 2012-10-01 |
| Locations: | Prism Research, Saint Paul, Minnesota, 55114, United States |
| URL: | https://clinicaltrials.gov/show/NCT01427257 |
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