Recent Updates
Recently added Catalysts

single dose of vepdegestrant as formulation

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 25, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

single dose of vepdegestrant as formulation · 2 trials · 1 indication

Phase 1 2
NCT06645938A Study to Learn How Different Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood in Healthy AdultsHealthy
COMPLETED12 Analytics
NCT06347861A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy AdultsHealthy
COMPLETED52 Analytics
PHASE1COMPLETED
A Study to Learn How Different Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood in Healthy Adults
Healthy
NCT0664593812
Unlock trial analytics
PHASE1COMPLETED
A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults
Healthy
NCT0634786152
Unlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of Vepdegestrant
Period 1 and 2 - pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, and 168 hour(s) post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Vepdegestrant
Period 1 and 2 - pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, and 168 hour(s) post-dose
Maximum observed concentration (Cmax) for vepdegestrant
Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168 hours post dose
Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for vepdegestrant
Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168 hours post dose

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Secondary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Number of Participants With Clinical Laboratory Abnormalities.
Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs.
Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence 1: Treatment A followed by Treatment BEXPERIMENTALParticipants will receive a single 200 mg dose of vepdegestrant registrational tablet on Day 1 of Period 1 followed by a single 200 mg dose of vepdegestrant variant tablet on Day 1 of Period 2.
Sequence 2: Treatment B followed by Treatment AEXPERIMENTALParticipants will receive a single 200 mg dose of vepdegestrant variant tablet on Day 1 of Period 1 followed by a single 200 mg dose of vepdegestrant registrational tablet on Day 1 of Period 2.
single dose of vepdegestrant (3-period, 3-treatment, 6-sequence, crossover)EXPERIMENTALVepdegestrant administered as a single dose in Period 1, 2 and 3.

Interventions

NameTypeDescription
single dose of vepdegestrant as tablet formulation (Treatment A)DRUGSingle 200 mg dose of vepdegestrant registrational (200 mg strength) tablet.
single dose of vepdegestrant as tablet formulation (Treatment B)DRUGSingle 200 mg dose of vepdegestrant variant (200 mg strength) tablet.
single dose of vepdegestrant as tablet formulation (Treatment C)DRUGregistration tablets
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male participants, and/or female participants of non-childbearing potential aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation, including medical history, physical...

Countries:BelgiumUnited States
Unlock Eligibility Criteria