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Completed

NCT Number: NCT07566130

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

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).

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 274374

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-- 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.

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

Placebo

Drug

Oral

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of nacresertib

    Time frame: Up to Day 19

    Cmax of nacresertib

  2. Time to Cmax (Tmax) of nacresertib

    Time frame: Up to Day 19

    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 Day 19

    AUCt of nacresertib

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

    Time frame: Up to Day 19

    AUCinf of nacresertib

  5. Part 2 Only: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of nacresertib

    Time frame: Up to Day 14

    AUCtau of nacresertib

  6. Terminal Phase Elimination Rate Constant (Beta) of nacresertib

    Time frame: Up to Day 19

    Beta of nacresertib

  7. Terminal Phase Elimination Half-Life (t1/2) of nacresertib

    Time frame: Up to Day 19

    t1/2 of nacresertib

  8. Dose Normalized Cmax

    Time frame: Up to Day 19

    Dose Normalized Cmax

  9. Dose Normalized AUCs

    Time frame: Up to Day 19

    Dose Normalized AUCs

  10. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: 74 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 Following Single and Multiple Ascending Oral Doses of Nacresertib in Healthy Adult Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
Jun 4, 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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