Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
single dose of vepdegestrant as formulation · 2 trials · 1 indication
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 - ∞).
| Arm | Type | Description |
|---|---|---|
| Sequence 1: Treatment A followed by Treatment B | EXPERIMENTAL | Participants 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 A | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Vepdegestrant administered as a single dose in Period 1, 2 and 3. |
| Name | Type | Description |
|---|---|---|
| single dose of vepdegestrant as tablet formulation (Treatment A) | DRUG | Single 200 mg dose of vepdegestrant registrational (200 mg strength) tablet. |
| single dose of vepdegestrant as tablet formulation (Treatment B) | DRUG | Single 200 mg dose of vepdegestrant variant (200 mg strength) tablet. |
| single dose of vepdegestrant as tablet formulation (Treatment C) | DRUG | registration tablets |
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...
Single dose of vepdegestrant as tablet formulation (Treatment A) is an investigational oral tablet form of vepdegestrant studied in healthy adult volunteers. It was evaluated in Phase 1 pharmacokinetic studies to learn how different tablets of the study medicine are taken up into the blood. It is not a marketed product.
Vepdegestrant is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer conducted the Phase 1 tablet formulation studies of single dose of vepdegestrant as tablet formulation (Treatment A) in healthy adult participants.
Single dose of vepdegestrant as tablet formulation (Treatment A) is in Phase 1 development. Both of its recorded trials are Phase 1 pharmacokinetic studies in healthy adults, and both are completed. It is an investigational formulation and is not an approved medicine.
Two completed Phase 1 trials studied this formulation. NCT06645938 enrolled 12 healthy adults in Belgium, and NCT06347861 enrolled 52 healthy adults in the United States. Both were controlled, randomized studies in participants aged 18 years and older, with 64 participants total across the two trials.
Yes. Single dose of vepdegestrant as tablet formulation (Treatment A) is an alternative name for a single dose of vepdegestrant given as a tablet formulation. Searches for either name refer to the same investigational oral tablet studied in the Phase 1 pharmacokinetic trials.