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Clinical Trial Details

Trial ID: L7237
Source ID: NCT00896077
Associated Drug: Lisofylline
Title: Subcutaneous Administration of Lisofylline to Healthy Normal Subjects and Subjects With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Healthy|Type 1 Diabetes
Interventions: DRUG: Lisofylline
Outcome Measures: Primary: Safety (based on AEs, vital signs assessments, resting 12-lead ECG evaluations, physical examination findings and clinical laboratory test results), LSF Plasma levels: D1-2, 7-8; T 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 h; D2, 8; T 5, 10, 15, 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 h post inf. Cytokine, chemokine, insulin, free fatty acid STAT4 phosphorylation in monocytes: D1-2, 7-8 | Secondary: Pharmacokinetic (PK) parameters will include AUC0-t, AUC0-inf, Cmax, Tmax, t1/2, kel, CL, Vdss and F, LSF Plasma levels: D1-2, 7-8; T 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 h; D2, 8; T 5, 10, 15, 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 h post inf. Cytokine, chemokine, insulin, free fatty acid STAT4 phosphorylation in monocytes: D1-2, 7-8|Pharmacodynamic (PD) assessments (blood will be collected for determination of serum cytokine, chemokine, insulin and FFA levels at time points noted previously), LSF Plasma levels: D1-2, 7-8; T 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 h; D2, 8; T 5, 10, 15, 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 h post inf. Cytokine, chemokine, insulin, free fatty acid STAT4 phosphorylation in monocytes: D1-2, 7-8
Sponsor/Collaborators: Sponsor: DiaKine Therapeutics, Inc.
Gender: ALL
Age: ADULT
Phases: PHASE1|PHASE2
Enrollment: 8
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
Start Date: 2009-05
Completion Date: 2009-12
Results First Posted:
Last Update Posted: 2014-07-29
Locations: Advanced Biomedical Research, Inc. (ABR), Hackensack, New Jersey, 07601, United States
URL: https://clinicaltrials.gov/show/NCT00896077