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 being developed by AbbVie Inc. It is in Phase 1 clinical development, with studies conducted to date in healthy adult volunteers rather than in patients with a disclosed disease. No therapeutic indication for nacresertib has been publicly disclosed.
Nacresertib is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the drug.
Nacresertib is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Three Phase 1 trials have been registered, of which two are completed and one is active but no longer recruiting participants.
Three Phase 1 trials of nacresertib are registered. NCT07566130 evaluated single and ascending oral doses in healthy adults and is completed. NCT07600762 assessed a single oral dose in healthy Japanese adults and is completed. NCT07649954 is examining multiple-dose interactions with itraconazole in healthy adults and is active but not recruiting.
Across the three registered Phase 1 trials, total planned enrollment for nacresertib is 117 participants. NCT07566130 accounts for 93 of these, while NCT07600762 and NCT07649954 each enroll 12 healthy adult participants.
The nacresertib Phase 1 program includes randomized, double-blind, controlled studies. All three registered trials enrolled healthy adult volunteers aged 18 years and older in the United States, including a dedicated study in healthy Japanese participants and a drug interaction study with itraconazole.