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

NCT07566130 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: M25-471
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (8)

Part 1: Dose A

EXPERIMENTAL

Participants will receive a single dose of nacresertib or Placebo

Drug: nacresertib; Drug: Placebo

Part 1: Dose B

EXPERIMENTAL

Participants will receive a single dose of nacresertib or Placebo

Drug: nacresertib; Drug: Placebo

Part 1: Dose C

EXPERIMENTAL

Participants will receive a single dose of nacresertib or Placebo

Drug: nacresertib; Drug: Placebo

Part 1: Dose D

EXPERIMENTAL

Participants will receive a single dose of nacresertib or Placebo

Drug: nacresertib; Drug: Placebo

Part 1: Dose E

EXPERIMENTAL

Participants will receive a single dose of nacresertib or Placebo

Drug: nacresertib; Drug: Placebo

Part 2: Dose F

EXPERIMENTAL

Participants will receive multiple doses of nacresertib or Placebo

Drug: nacresertib; Drug: Placebo

Part 2: Dose G

EXPERIMENTAL

Participants will receive multiple doses of nacresertib or Placebo

Drug: nacresertib; Drug: Placebo

Part 2: Dose H

EXPERIMENTAL

Participants will receive multiple doses of nacresertib or Placebo

Drug: nacresertib; Drug: Placebo

Interventions

nacresertib DRUG

Oral

Part 1: Dose A; Part 1: Dose B; Part 1: Dose C; Part 1: Dose D; Part 1: Dose E; Part 2: Dose F; Part 2: Dose G; Part 2: Dose H

Placebo DRUG

Oral

Part 1: Dose A; Part 1: Dose B; Part 1: Dose C; Part 1: Dose D; Part 1: Dose E; Part 2: Dose F; Part 2: Dose G; Part 2: Dose H

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \-- 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.

You may not qualify if:

• 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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\]

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 274374

Grayslake, Illinois, 60030, United States

Location

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 4, 2026
• Study Start: April 18, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)