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Clinical Trial Details

Trial ID: L5917
Source ID: NCT03288740
Associated Drug: Semaglutide 0.5 Mg
Title: A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide 0.5 mg|DRUG: Placebo (semaglutide 0.5 mg)|DRUG: Semaglutide 1.0 mg|DRUG: Placebo (semaglutide 1.0 mg)
Outcome Measures: Primary: Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg), Calculated based on semaglutide measured in blood., 0-168 hours after last administration of semaglutide|Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg), Calculated based on semaglutide measured in blood., 0-168 hours after last administration of semaglutide | Secondary: Maximum observed semaglutide plasma concentration at steady state, Calculated based on semaglutide measured in blood., 0-168 hours after last administration of semaglutide|Time to maximum observed semaglutide plasma concentration at steady state, Calculated based on semaglutide measured in blood., 0-168 hours after last administration of semaglutide|Total apparent clearance of semaglutide at steady state, Calculated based on semaglutide measured in blood., 0-168 hours after last administration of semaglutide|Terminal elimination half-life of semaglutide at steady state, Calculated based on semaglutide measured in blood., 0-840 hours after last administration of semaglutide|Apparent volume of distribution of semaglutide at steady state, Calculated based on semaglutide measured in blood., 0-840 hours after last administration of semaglutide|Trough plasma semaglutide concentration, Calculated based on semaglutide measured in blood., Before dosing at day 29, 57, 78, 85 and 92|Dose-corrected accumulation ratio, Calculated based on semaglutide measured in blood., Based on the area under the semaglutide plasma concentration curve from 0-168 hours after the first dose and the area under the semaglutide plasma concentration curve 0-168 hours after the last dose|Area under the semaglutide plasma concentration time curve, Calculated based on semaglutide measured in blood., 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)|Maximum observed semaglutide plasma concentration, Calculated based on semaglutide measured in blood., 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)|Time to maximum observed semaglutide plasma concentration, Calculated based on semaglutide measured in blood., 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)|Number of treatment emergent adverse events (TEAEs), Count and % of adverse events, Visit 2 (Day 1) - visit 23 (Day 120-127)|Number of hypoglycaemic episodes, Count of episodes, Visit 2 (Day 1) - visit 23 (Day 120-127)|Incidence of anti-semaglutide antibodies (positive/negative) at follow-up, Count of episodes, Visit 23 (Day 120-127)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-09-21
Completion Date: 2018-08-07
Results First Posted:
Last Update Posted: 2021-02-15
Locations: Novo Nordisk Investigational Site, Beijing, 100730, China
URL: https://clinicaltrials.gov/show/NCT03288740