A Study to Assess Adverse Events, Tolerability and How Single and Ascending Oral Doses of Nacresertib Move Through the Body In Healthy Adult Participants

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Ascending Oral Doses of Nacresertib in Healthy Adult Subjects

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: nacresertib

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 274374

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of any clinically significant sensitivity or allergy to any medication or food.
• History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose A; Participants will receive a single dose of nacresertib or Placebo	Drug: Placebo; Oral; Drug: nacresertib; Oral
Experimental: Part 1: Dose B; Participants will receive a single dose of nacresertib or Placebo	Drug: Placebo; Oral; Drug: nacresertib; Oral
Experimental: Part 1: Dose C; Participants will receive a single dose of nacresertib or Placebo	Drug: Placebo; Oral; Drug: nacresertib; Oral
Experimental: Part 1: Dose D; Participants will receive a single dose of nacresertib or Placebo	Drug: Placebo; Oral; Drug: nacresertib; Oral
Experimental: Part 1: Dose E; Participants will receive a single dose of nacresertib or Placebo	Drug: Placebo; Oral; Drug: nacresertib; Oral
Experimental: Part 2: Dose F; Participants will receive multiple doses of nacresertib or Placebo	Drug: Placebo; Oral; Drug: nacresertib; Oral
Experimental: Part 2: Dose G; Participants will receive multiple doses of nacresertib or Placebo	Drug: Placebo; Oral; Drug: nacresertib; Oral
Experimental: Part 2: Dose H; Participants will receive multiple doses of nacresertib or Placebo	Drug: Placebo; Oral; Drug: nacresertib; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2025
• Primary Completion (Actual): May 7, 2026
• Study Completion (Actual): May 7, 2026

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: M25-471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No