A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese Participants

NCT07600762 | Completed Phase 1 FDA Drug

• 1 other identifier: M25-765
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese Participants

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of Nacresertib

  Cmax of Nacresertib

  Up to 9 Days

• Time to Cmax (Tmax) of Nacresertib

  Tmax of Nacresertib

  Up to 9 Days

• 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 9 Days

• AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib

  AUCinf of Nacresertib

  Up to 9 Days

• Terminal Phase Elimination Rate Constant (Beta) of Nacresertib

  Beta of Nacresertib

  Up to 9 Days

• Terminal Phase Elimination Half-Life (t1/2) of Nacresertib

  t1/2 of Nacresertib

  Up to 9 Days

• 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

  Up to 42 Days

Study Arms (2)

Nacresertib

EXPERIMENTAL

Participants will receive a single dose of Nacresertib

Drug: Nacresertib

Placebo for Nacresertib

PLACEBO COMPARATOR

Participants will receive a single dose of Placebo for Nacresertib

Drug: Placebo for Nacresertib

Interventions

Nacresertib DRUG

Oral tablet

Nacresertib

Placebo for Nacresertib DRUG

Oral tablet

Placebo for Nacresertib

Eligibility Criteria

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

You may qualify if:

• Healthy Japanese male or female; 18 to 65 years of age at the time of screening.
• Japanese participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.
• BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.

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)

CenExel ACT- Anaheim Clinical Trials /ID# 282482

Anaheim, California, 92801, United States

Location

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 22, 2026
• Study Start: April 21, 2026
• Primary Completion: June 17, 2026
• Study Completion: June 17, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)