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

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT07566130
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • nacresertib — DRUG
    Oral
  • Placebo — DRUG
    Oral

Study Details

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).

Key Dates

Start date
Apr 18, 2025
Status verified
Jun 2026
Primary completion
May 7, 2026
Completion
May 7, 2026

Study Design

Enrollment
93 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1: Dose A
    Participants will receive a single dose of nacresertib or Placebo
  • Experimental: Part 1: Dose B
    Participants will receive a single dose of nacresertib or Placebo
  • Experimental: Part 1: Dose C
    Participants will receive a single dose of nacresertib or Placebo
  • Experimental: Part 1: Dose D
    Participants will receive a single dose of nacresertib or Placebo
  • Experimental: Part 1: Dose E
    Participants will receive a single dose of nacresertib or Placebo
  • Experimental: Part 2: Dose F
    Participants will receive multiple doses of nacresertib or Placebo
  • Experimental: Part 2: Dose G
    Participants will receive multiple doses of nacresertib or Placebo
  • Experimental: Part 2: Dose H
    Participants will receive multiple doses of nacresertib or Placebo

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of nacresertib [ Time Frame: Up to Day 19 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Acpru /Id# 274374GrayslakeIllinois60030-

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Acpru· Grayslake, IL

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