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Completed

NCT Number: NCT07600762

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

Completed

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel ACT- Anaheim Clinical Trials /ID# 282482

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.].

Treatment and study plan

nacresertib

Drug

Oral tablet

Placebo for Nacresertib

Drug

Oral tablet

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Nacresertib

    Time frame: Up to 9 Days

    Cmax of Nacresertib

  2. Time to Cmax (Tmax) of Nacresertib

    Time frame: Up to 9 Days

    Tmax of Nacresertib

  3. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Nacresertib

    Time frame: Up to 9 Days

    AUCt of Nacresertib

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

    Time frame: Up to 9 Days

    AUCinf of Nacresertib

  5. Terminal Phase Elimination Rate Constant (Beta) of Nacresertib

    Time frame: Up to 9 Days

    Beta of Nacresertib

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

    Time frame: Up to 9 Days

    t1/2 of Nacresertib

  7. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to 42 Days

    Any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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