Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511, United States
NCT Number: NCT06541678
The purpose of this study is to see how single dose of cyclosporine and multiple doses of itraconazole affect the level of the study medicine danuglipron in the blood of healthy adult participants. The information from this study may inform how danuglipron will be used in the future with medicines like cyclosporine and itraconazole.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06511, United States
This study is seeking healthy participants who:
Participants will receive danuglipron tablet by mouth on Day 1. Then on Day 4, participants will take cyclosporine capsules and danuglipron tablet by mouth at the same time. From Day 7 of the study, participants will take itraconazole solution by mouth once a day until Day 12. On Day 10 of the study, danuglipron tablet will also be taken with itraconazole at the same time.
The total planned time of participation is about 10 weeks. The study consists of:
screening period of up to 28 days before taking sisunatovir. 13 days of staying in the study clinic. a follow-up contact that will occur 28 to 35 days after taking itraconazole the last time.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prior/Concomitant Therapy:
Prior/Concurrent Clinical Study Experience:
MR Tablet
Other names: PF-06882961
Capsule
Oral solution
Time frame: 0 to 72 hour postdose
AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time
AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.
Time frame: 0 to 72 hour postdose
Maximum observed plasma concentration
Time frame: 0 to 72 hour postdose
AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time
AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.
Time frame: 0 to 72 hour postdose
Maximum observed plasma concentration
Time frame: Day 1 up to approximately Day 47
Time frame: Day 1 up to approximately Day 47
Time frame: Day 1 up to approximately Day 47
Time frame: Day 1 up to approximately Day 47
Pfizer
Industry
A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole and Cyclosporine on the Single-Dose Pharmacokinetics of Danuglipron in Healthy Adult 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.
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