Trials / Completed
CompletedNCT06347861
A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults
A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, 3-TREATMENT, 6-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY ADULT PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF THE REGISTRATION TABLETS OF VEPDEGESTRANT (ARV-471, PF-07850327) RELATIVE TO THE PHASE 3 TABLETS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to look at how various tablets of a study medicine called vepdegestrant are processed in the body. This will be studied in healthy adult participants after food. This study looks at how the medicine is changed and removed from the body after a participant takes it. This study is seeking for participant who: * are healthy males, and healthy females who do not have the possibility to have children. * are 18 years of age or older. * weigh more than 45 Kilograms (99 pounds). The study consists of 3 treatments. Each participant will be assigned by chance to receive the 3 treatments in a certain sequence. This will be done over 3 study periods. Each treatment consists of a single amount of vepdegestrant taken by mouth in each study period. There will be a washout period between each study periods. The washout period is the time allowed for the medicine to get washed out from the body. How the medicine was processed will be calculated following each dose in each period. The total study duration is about 13 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | single dose of vepdegestrant as tablet formulation (Treatment A) | phase 3 tablets |
| DRUG | single dose of vepdegestrant as tablet formulation (Treatment B) | registration tablets |
| DRUG | single dose of vepdegestrant as tablet formulation (Treatment C) | registration tablets |
Timeline
- Start date
- 2024-04-02
- Primary completion
- 2024-07-22
- Completion
- 2024-08-08
- First posted
- 2024-04-04
- Last updated
- 2024-10-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06347861. Inclusion in this directory is not an endorsement.