Clinical TrialID 8184
A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults
NCT05745701
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8184
- Evidence Id
- 8184
- Core Evidence Id
- 8184
- Source Clinical Trial Id
- 8182
- Herb2 Clinical Trial Id
- HBCT008182
- Nct Id
- NCT05745701
- Title
- A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Healthy
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: PF-07081532|DEVICE: Cyclosporine|DRUG: Itraconazole
- Intervention Allocation
- Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 16
- Outcome Measure
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Lotiglipron When Administered Alone and With Itraconazole or Cyclosporine, AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf is caluculated by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis., Pre-dose of lotiglipron and at 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, and 144 (for Period 3 only) hours post dose of lotiglipron on Day 1 of Periods 1 and 2 and on Day 4 of Period 3.
- Sponsor Collaborator
- Pfizer
- Funded By
- INDUSTRY
- Location
- New Haven Clinical Research Unit, New Haven, Connecticut, 06511, United States
- Other Id
- C3991041
- Start Date
- 2023-02-22
- Primary Completion Date
- 2023-05-29
- Completion Date
- 2023-05-29
- First Posted
- 2023-02-27
- Results First Posted
- 2024-09-23
- Last Update Posted
- 2024-09-23
- Study Document
- Study Protocol, https://cdn.clinicaltrials.gov/large-docs/01/NCT05745701/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/01/NCT05745701/SAP_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT05745701
- Title Cn
- Title En
- A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults
- Bilingual Status
- semi_complete