RecruitingPhase 1NCT07600762

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

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


Sponsor

AbbVie

Enrollment

12 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria3

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

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Interventions

DRUGNascertib

Oral tablet

DRUGPlacebo for Nascertib

Oral tablet


Locations(1)

CenExel ACT- Anaheim Clinical Trials /ID# 282482

Anaheim, California, United States

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NCT07600762


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