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Clinical Trial Details

Trial ID: L5477
Source ID: NCT02430870
Associated Drug: Tak-648
Title: TAK-648 Multiple-Rising Dose Study in Healthy Japanese Participants and Non-Japanese Participants With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02430870/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: TAK-648|DRUG: Placebo
Outcome Measures: Primary: Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 1, An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug., Up to Day 34|Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2, An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug., Up to Day 26|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1, Up to Day 20|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2, Up to Day 13|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1, Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm)., Up to Day 20|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2, Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm),, Up to Day 13|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1, Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions., Up to Day 20|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2, Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions., Up to Day 13 | Secondary: Cmax: Maximum Plasma Concentration for TAK-648 for Part 1, Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|Cmax: Maximum Plasma Concentration for TAK-648 for Part 2, Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1, Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2, Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1, Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2, Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1, Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2, Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1, Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2, Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-04
Completion Date: 2015-11
Results First Posted: 2016-08-31
Last Update Posted: 2016-08-31
Locations: Anaheim, California, United States|Chula Vista, California, United States
URL: https://clinicaltrials.gov/show/NCT02430870