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

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Nacresertib in Healthy Adult Japanese Subjects

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Nacresertib; Drug: Placebo for Nacresertib

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • CenExel ACT- Anaheim Clinical Trials /ID# 282482

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nacresertib; Participants will receive a single dose of Nacresertib	Drug: Nacresertib; Oral tablet
Placebo Comparator: Placebo for Nacresertib; Participants will receive a single dose of Placebo for Nacresertib	Drug: Placebo for Nacresertib; Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer
• Other Study ID Numbers: M25-765

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