LivingGLP1
Study S002211

A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETIC INTERACTIONS BETWEEN PF-06882961 AND PF-06865571 IN HEALTHY ADULT PARTICIPANTS (PART A) AND OVERWEIGHT ADULTS OR ADULTS WITH OBESITY WHO ARE OTHERWISE HEALTHY (PART B)

ClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT04839393
Study type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Phase
PHASE1
Masking
NONE
Status
COMPLETED
Enrollment
27
Start
2021-04-05
Primary completion
2021-10-10
Lead sponsor
Pfizer
Conditions
Healthy Volunteer
Interventions
DRUG:PF-06882961 followed by PF-06882961/PF-06865571; DRUG:PF-06882961/PF-06865571 followed by PF-06882961; DRUG:PF-06882961 + PF-06865571
Results posted
TRUE
Individual participant data sharing
NO

Registered primary outcomes

  • Part A: PF-06882961 Maximum Observed Concentration (Cmax) [0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1]
  • Part A: PF-06882961 Area Under the Plasma Concentration-time Profile From Time 0 to the Time 24 Hours Post-dose (AUC24) [0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1]
  • Part B: PF-06865571 Cmax on Day 1 and Day 47 [0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dose]
  • Part B: PF-06865571 Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) on Day 1 and Day 47 [0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dose]
  • Part B: PF-06865571 Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) on Day 1 and Day 47 [0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dose]
  • Part B: PF-06882961 Cmax on Day 46 and Day 61 [0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose]
  • Part B: PF-06882961 Area Under the Plasma Concentration-time Profile From Time 0 to the Time 12 Hours Post-dose (AUC12) on Day 46 and Day 61 [0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose]

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