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NCT06256510
A Study to Learn If the Study Medicine Called Vepdegestrant Changes How the Body Processes the Other Study Medicine Called Midazolam
Phase 1 trial testing Midazolam in Healthy Participants in 15 participants. Completed in 13 May 2024.
16 April 2024
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 15 |
| Start date | 8 February 2024 |
| Primary completion | 16 April 2024 |
| Estimated completion | 13 May 2024 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Midazolam (midazolam) — full drug profile →
- Vepdegestrant — full drug profile →
Conditions studied
- Healthy Participants — all drugs for Healthy Participants →
Sponsor
Pfizer — full company profile →
Who can join
18 and older, female only, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to learn if the study medicine called Vepdegestrant changes how the body processes the other study medicine called Midazolam. This study is seeking participants who: * female who cannot have children. * are 18 years or older. * are overtly healthy as decided by medical tests. * have a body mass index (BMI) of 16 to 32 kilogram per meter squared. * have a total body weight of more than 45 kilograms (99 pounds). All participants in this study will receive one dose of midazolam alone by mouth in Period 1. In Period 2, all participants will receive vepdegestrant by mouth once a day for 15 days. Participants will also receive one dose of midazolam by mouth on day 1 and day 15. The levels of midazolam in Period 1 will be compared to the levels of midazolam in Period 2 Day 1 and Day 15 to decide if vepdegestrant affects how midazolam is processed differently in healthy adults. The study duration is 22 days and includes two periods. Participants will stay in the clinical research unit through the end of period 2. A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
PROTAC Technology as a New Tool for Modern Pharmacotherapy.
Kubryń N, Fijałkowski Ł, Nowaczyk J, Jamil A, et al · · 2025 · cited 13× · PMID 40430296 · DOI 10.3390/molecules30102123 -
Proteolysis-Targeting Chimera (PROTAC): Current Applications and Future Directions.
Fan G, Chen S, Zhang Q, Yu N, et al · · 2025 · cited 6× · PMID 41049269 · DOI 10.1002/mco2.70401 -
Recent advances in targeting protein degradation for tumor immunotherapy.
Li S, Jin Y, Wu H, Yuan H, et al · · 2025 · PMID 41345706 · DOI 10.1186/s13045-025-01765-4
Verify or expand the search:
- PubMed search for NCT06256510
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06256510 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 21 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06256510.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing