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The objectives for this 2 Part study are to assess the safety, tolerability, and pharmacokinetics following single ascending oral doses of nacresertib in healthy adult participants (Part 1) and to assess the safety, tolerability, and pharmacokinetics following multiple ascending oral doses in healthy adult participants (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose A | Experimental | Participants will receive a single dose of nacresertib or Placebo |
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| Part 1: Dose B | Experimental | Participants will receive a single dose of nacresertib or Placebo |
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| Part 1: Dose C | Experimental | Participants will receive a single dose of nacresertib or Placebo |
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| Part 1: Dose D | Experimental | Participants will receive a single dose of nacresertib or Placebo |
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| Part 1: Dose E | Experimental | Participants will receive a single dose of nacresertib or Placebo |
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| Part 2: Dose F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nacresertib | Drug | Oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of nacresertib | Cmax of nacresertib | Up to Day 19 |
| Time to Cmax (Tmax) of nacresertib | Tmax of nacresertib | Up to Day 19 |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of nacresertib | AUCt of nacresertib | Up to Day 19 |
| AUC From Time 0 to the Time Infinity (AUCinf) of nacresertib | AUCinf of nacresertib | Up to Day 19 |
| Part 2 Only: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of nacresertib | AUCtau of nacresertib | Up to Day 14 |
| Terminal Phase Elimination Rate Constant (Beta) of nacresertib | Beta of nacresertib | Up to Day 19 |
| Terminal Phase Elimination Half-Life (t1/2) of nacresertib | t1/2 of nacresertib | Up to Day 19 |
| Dose Normalized Cmax | Dose Normalized Cmax | Up to Day 19 |
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Inclusion Criteria:
-- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 274374 | Grayslake | Illinois | 60030 | United States |
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Participants will receive multiple doses of nacresertib or Placebo
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| Part 2: Dose G | Experimental | Participants will receive multiple doses of nacresertib or Placebo |
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| Part 2: Dose H | Experimental | Participants will receive multiple doses of nacresertib or Placebo |
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| Placebo | Drug | Oral |
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| Dose Normalized AUCs | Dose Normalized AUCs | Up to Day 19 |
| Number of Participants Experiencing Adverse Events (AEs) | Any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment | 74 Days |