Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511, United States
NCT Number: NCT07190430
The purpose of this study is to see how a medicine called PF-08049820 affects how other medicines move through the body. This information will help plan future studies. The other medicines include:
* Birth control pills (containing ethinyl estradiol and levonorgestrel) * Midazolam (used to help people relax or sleep) * Dabigatran etexilate (used to prevent blood clots)
This study is seeking participants who:
* are female and are 18 years or older * weigh more than 110 pounds (50 kg) * have a healthy body weight (not too low or too high) * are generally healthy with no serious medical problems. People with serious health problems, recent medicine use, or who had certain vaccines recently cannot join. * are willing to follow all the study rules The study has 6 parts, and each part happens one after the other. In the first 3 parts, participants take just one dose of each medicine (midazolam, dabigatran, and birth control pills) to see how these medicines work alone. In the last 3 parts, they take PF-08049820 twice a day, along with one of the other medicines, to see how PF-08049820 changes the way those medicines move through the body. The whole study will take about 12 to13 weeks and participants will stay overnight in the clinic for about 25 days.
This study is active but is not currently recruiting participants.
18 year and older
Female
Interventional
Phase 1
New Haven, Connecticut, 06511, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally
Administered orally
Administered orally
Administered orally
Time frame: From pre-dose up to 24 hours post dose in Periods 1 and 4
Time frame: From pre-dose up to 24 hours post dose in Periods 1 and 4
Time frame: From pre-dose up to 48 hours post dose in Periods 2 and 5
Time frame: From pre-dose up to 48 hours post dose in Periods 2 and 5
Time frame: From pre-dose up to 96 hours post dose in Periods 3 and 6
Time frame: From pre-dose up to 96 hours post dose in Periods 3 and 6
Time frame: First dose of study intervention until Follow Up Visit (28 to 35 days after the last dose)
Time frame: Baseline to Study Day 24
Time frame: Baseline to Study Day 24
Time frame: Baseline to Study Day 24
Pfizer
Industry
A Phase 1, Open-label, Fixed Sequence Study to Evaluate The Effect of Steady-State Dosing of PF-08049820 on the Single Dose Pharmacokinetics of Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult 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.
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