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Clinical Trial Details

Trial ID: L3463
Source ID: NCT06279234
Associated Drug: Placebo
Title: A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus (T2DM)|Obesity
Interventions: DRUG: Placebo|DRUG: Rosuvastatin|DRUG: Midazolam|DRUG: Omeprazole|DRUG: PF-06954522
Outcome Measures: Primary: Number of Participants Reporting Adverse Events, Baseline through Week 14|Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities, Baseline through Week 14|Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Baseline through Week 14|Number of Participants With Clinically Significant Change From Baseline in 12-Lead ECGs, Baseline through Week 14|Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS), Baseline through Week 14 | Secondary: Maximum Observed Plasma Concentration (Cmax), Part A: Days -1, 1, 14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24, 30. Part A & B: Days -1, 1, 28, 49 & 56. Days 7, 14, 21, 35, 42, 57 & 58. Part C: Period 3 Day 3 & Period 5 Day 28|Area Under the Curve from Time Zero to end of dosing interval (AUCtau), Part A: Days -1, 1, 14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24, 30. Part A & B: Days -1, 1, 28, 49 & 56. Days 7, 14, 21, 35, 42, 57, 58. Part C: Period 3 Day 3 & Period 5 Day 28|Time to Reach Maximum Observed Plasma Concentration (Tmax), Part A: Days -1, 1, 14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24 & 30. Part A & B: Day -1, 1 28, 49 & 56. Days 7, 14, 21, 35, 42, 57 & 58. Part C: Period 3 Day 3 & Period 5 Day 28|Plasma Decay Half-Life (t1/2), Part A: Day -1, 1,14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24 & 30. Part A & B: Day -1, 1, 28, 49 & 56. Days 7, 14, 21, 35, 42, 57 & 58. Part C: Period 3 Day 3 & Period 5 Day 28|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau), Part A: Day 28. Part A & B: Day 56|Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%), Part A: Day 28. Part A & B: Day 56|Renal Clearance (CLr), Part A: Day 28. Part A & B: Day 56
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 45
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-02-20
Completion Date: 2025-04-07
Results First Posted:
Last Update Posted: 2025-02-13
Locations: Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States|Qps-Mra, Llc, South Miami, Florida, 33143, United States
URL: https://clinicaltrials.gov/show/NCT06279234