PF-06651600
Drug50 mg by mouth (PO) once daily (QD)
NCT Number: NCT04018274
This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 06651600 on single-dose oral contraceptive (OC) pharmacokinetics (PK) in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 28 healthy female subjects (14 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods.
Looking for future studies?
Notify Me18 year–60 year
Female
Interventional
Phase 1
Quotient Sciences Screening Office, Coral Gables, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
Exclusion criteria
50 mg by mouth (PO) once daily (QD)
Oral tablet containing 30 ug EE and 150 ug of LN
Other names: Oral contraceptives
Time frame: predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2
30 micrograms administered as oral OC combination tablet
Time frame: predose, 30 minutes and 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post OC dose in Periods 1 and 2
150 micrograms administered as oral OC combination tablet
Pfizer
Industry
A PHASE 1, RANDOMIZED, OPEN LABEL, 2 WAY CROSSOVER STUDY TO DEMONSTRATE A LACK OF AN EFFECT OF MULTIPLE DOSE PF 06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details