LivingGLP1
Study S001143

A Phase 1, Open-label Study In Healthy Subjects To Evaluate The Pharmacokinetics Of Pf-06882961 Following Single Oral Administration Of Immediate Release Tablets And An Immediate Release Oral Solution In The Fed State, And Controlled Release Tablets In The Fed And Fasted States

ClinicalTrials.gov record

Registration

Registration
NCT03492697
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE1
Masking
NONE
Status
COMPLETED
Enrollment
12
Start
2018-04-30
Primary completion
2018-07-18
Lead sponsor
Pfizer
Conditions
Healthy Subjects
Interventions
DRUG:PF-06882961 Immediate Release Tablet; DRUG:PF-06882961 Controlled Release Tablet (long); DRUG:PF-06882961 Controlled Release Tablet (short); DRUG:PF-06882961 Immediate Release Solution
Results posted
FALSE
Individual participant data sharing
NO

Registered primary outcomes

  • Maximum Observed Plasma Concentration (Cmax) for PF-06882961 [0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period]
  • Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961 [0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period]
  • Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast) [0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period]
  • Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit [0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period]
  • Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24) [24 hours post dose in each period]
  • Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit [0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period]
  • Apparent clearance (CL/F) for PF-06882961, as data permit [0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period]
  • Peak-to-trough (PTR) ratio for PF-06882961 [0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period]

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