NCT05093205

STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS

A PHASE 1, OPEN-LABEL, TWO-PART STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-06882961 ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF ATORVASTATIN AND MIDAZOLAM IN HEALTHY ADULTS AND AN ORAL CONTRACEPTIVE IN HEALTHY POST-MENOPAUSAL FEMALES

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the effect of PF-06882961, administered at 2 steady-state dose levels, on the PK of single doses of atorvastatin (20 mg) or midazolam (5 mg), administered separately, in healthy adult male and female participants (Part A), or an OC in healthy PM female participants (Part B).

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	PF-06882961	Tablets
DRUG	Atorvastatin	Tablets
DRUG	Midazolam	Syrup
DRUG	Levonorgestrel & Ethinyl Estradiol	Tablet

Timeline

• Start date: 2021-10-25
• Primary completion: 2022-07-06
• Completion: 2022-07-06
• First posted: 2021-10-26
• Last updated: 2024-08-19
• Results posted: 2024-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study