Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7081
Source ID: NCT04982705
Associated Drug: [Part 1.1] Idg-16177
Title: IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: [Part 1.1] IDG-16177|DRUG: [Part 1.1] Placebo of IDG-16177|DRUG: [Part 2] Sitagliptin|DRUG: [Part1.2] IDG-16177|DRUG: [Part 2] IDG-16177|DRUG: [Part 1.2] Placebo of IDG-16177|DRUG: [Part 2] Placebo of IDG-16177
Outcome Measures: Primary: AEs/serious AEs (SAEs), Incidence and severity of adverse event, Throughout study duration, up to 9 weeks|Percentage of subjects with clinically significant change from baseline in vital signs, Throughout study duration, up to 9 weeks|Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG), Throughout study duration, up to 9 weeks|Percentage of subejcts with clinically significant change from baseline in safety laboratory test results, Throughout study duration, up to 9 weeks | Secondary: Maximum concentration of IDG-16177(Cmax), Throughout study duration, up to 9 weeks|Time of maximum plasma IDG-16177 concentration (Tmax), Throughout study duration, up to 9 weeks|Area under the concentration-time curve (AUC), Throughout study duration, up to 9 weeks|Terminal elimination rate constant (λz), Throughout study duration, up to 9 weeks|Terminal elimination half-life calculated as: ln2/λz (T½), Throughout study duration, up to 9 weeks|Apparent total clearance of the drug from plasma after oral administration (CL/F), Throughout study duration, up to 9 weeks|Cumulative urinary excretion from time 0 to time t (Ae0-t), Throughout study duration, up to 9 weeks|Renal clearance of the drug from plasma (CLR), Throughout study duration, up to 9 weeks|Accumulation ratio (Rac), Throughout study duration, up to 9 weeks|Apparent volume of distribution following oral administration (Vd/F), Throughout study duration, up to 9 weeks | Other: Insulin, plasma concentration, Through the treatment; Plasma concentration will be observed at baseline and 0.25, 0.5, 1, 1.5, 2, 3 and 4 hours after dose|proinsulin, plasma concentration, Through the treatment; Plasma concentration will be observed at baseline and 0.25, 0.5, 1, 1.5, 2, 3 and 4 hours after dose|C-peptide, plasma concentration, Through the treatment; Plasma concentration will be observed at baseline and 0.25, 0.5, 1, 1.5, 2, 3 and 4 hours after dose|Glucagon, plasma concentration, Through the treatment; Plasma concentration will be observed at baseline and 0.25, 0.5, 1, 1.5, 2, 3 and 4 hours after dose|Glucose, plasma concentration, Through the treatment; Plasma concentration will be observed at baseline and 0.25, 0.5, 1, 1.5, 2, 3 and 4 hours after dose|HbA1c level, Change from baseline in HbA1c level, Through the treatment; Days 8, 15 and 28
Sponsor/Collaborators: Sponsor: IlDong Pharmaceutical Co Ltd
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 94
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-07-07
Completion Date: 2022-12-30
Results First Posted:
Last Update Posted: 2022-08-11
Locations: Parexel International GmbH Early Phase Clinical Unit Klinikum Westend, Berlin, 14050, Germany
URL: https://clinicaltrials.gov/show/NCT04982705