A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants

Conditions

• Healthy Volunteer

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Nacresertib — DRUG
  Oral Tablet
• Itraconazole — DRUG
  Oral Capsule

Study Details

This study will evaluate how multiple doses of Itraconazole Impacts the performance of Nacresertib in healthy adult participants The goal of this study is to assess the safety and drug to drug interaction between Itraconazole and Nacresertib. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

First listed

Jun 16, 2026

Start date

Jun 23, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

12 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Period 1: Nacresertib Only
  Participant receives single dose of Nacresertib administered on Day 1
• Experimental: Period 2: Nacresertib and Itraconazole
  Participant will receive itraconazole multiple times on Day 1, followed by a single dose of itraconazole on Days 2 through 11. Participants will also receive a single oral dose of Nacresertib on Day 4.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Nacresertib [ Time Frame: Up to Day 12 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (1)

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