Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
nacresertib · 3 trials · 2 indications
Cmax of Nacresertib
Tmax of Nacresertib
AUCt of Nacresertib
AUCinf of Nacresertib
Beta of Nacresertib
t1/2 of Nacresertib
Any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment
AUCtau of nacresertib
| Arm | Type | Description |
|---|---|---|
| Period 1: Nacresertib Only | EXPERIMENTAL | Participant receives single dose of Nacresertib administered on Day 1 |
| Period 2: Nacresertib and Itraconazole | EXPERIMENTAL | Participant will receive itraconazole multiple times on Day 1, followed by a single dose of itraconazole on Days 2 through 11. Participants will also receive a single oral dose of Nacresertib on Day 4. |
| Nacresertib | EXPERIMENTAL | Participants will receive a single dose of Nacresertib |
| Placebo for Nacresertib | PLACEBO_COMPARATOR | Participants will receive a single dose of Placebo for Nacresertib |
| Part 1: Dose A | EXPERIMENTAL | Participants will receive a single dose of nacresertib or Placebo |
| Part 1: Dose B | EXPERIMENTAL | Participants will receive a single dose of nacresertib or Placebo |
| Part 1: Dose C | EXPERIMENTAL | Participants will receive a single dose of nacresertib or Placebo |
| Part 1: Dose D | EXPERIMENTAL | Participants will receive a single dose of nacresertib or Placebo |
| Part 1: Dose E | EXPERIMENTAL | Participants will receive a single dose of nacresertib or Placebo |
| Part 2: Dose F | EXPERIMENTAL | Participants will receive multiple doses of nacresertib or Placebo |
| Part 2: Dose G | EXPERIMENTAL | Participants will receive multiple doses of nacresertib or Placebo |
| Part 2: Dose H | EXPERIMENTAL | Participants will receive multiple doses of nacresertib or Placebo |
| Name | Type | Description |
|---|---|---|
| Nacresertib | DRUG | Oral Tablet |
| Itraconazole | DRUG | Oral Capsule |
| Placebo for Nacresertib | DRUG | Oral tablet |
| Placebo | DRUG | Oral |
Inclusion Criteria: * Participants must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures. * Individuals 18 to 65 years of age at the time of screening. * Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after...
Nacresertib is an investigational small-molecule drug developed by AbbVie Inc. It is in Phase 1 clinical development, and the trials registered so far have been conducted in healthy adult volunteers rather than in patients with a disclosed disease. Its therapeutic indication has not been publicly specified.
Nacresertib is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the Phase 1 studies registered for the compound, all of which have been run in the United States.
Nacresertib is in Phase 1 development. Three Phase 1 trials are registered, and all three are listed as completed. The compound is investigational and is not described as approved for any indication; the studies to date have enrolled healthy volunteers.
Three completed Phase 1 trials are registered for Nacresertib: NCT07649954, a drug interaction study with itraconazole in 12 healthy participants; NCT07600762, a single-dose study in 12 healthy Japanese participants; and NCT07566130, a single and ascending dose study in 93 healthy participants. Total enrollment across the three was 117.
The registered Nacresertib trials assessed safety, tolerability, and pharmacokinetics in healthy adult volunteers. NCT07566130 evaluated adverse events and how single and ascending oral doses move through the body, NCT07600762 examined single-dose pharmacokinetics in Japanese participants, and NCT07649954 tested how multiple doses of itraconazole interact with Nacresertib.
Nacresertib is administered orally. The registered Phase 1 studies describe single oral doses and single and ascending oral doses in healthy adult participants, and one study evaluates multiple doses of itraconazole given alongside Nacresertib to assess the interaction between the two.