Recruiting NCT07222709
A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABBV-1042, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Double-blind, Placebo-controlled, First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ABBV-1042 in Healthy Subjects
Overview
This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.
Interventions
- Drug ABBV-1042
Oral Solution - Drug Placebo
Oral Solution
Primary outcome measures
- Number of Participants Experiencing Adverse Events [Time frame: Up to approximately 32 days]
- Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [Time frame: Up to approximately 3 days]
- Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Up to approximately 3 days]
- Number of Participants with Abnormal Change in Physical Examinations [Time frame: Up to approximately 3 days]
- Number of Participants with Change from Baseline in Electrocardiogram (ECG) [Time frame: Up to approximately 3 days]
- Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed [Time frame: Up to approximately 3 days]
- Maximum Plasma Concentration (Cmax) of ABBV-1042 [Time frame: Up to approximately 3 days]
- Time to Cmax (Tmax) of ABBV-1042 [Time frame: Up to approximately 3 days]
- Apparent terminal phase elimination constant (β) of ABBV-1042 [Time frame: Up to approximately 3 days]
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042 [Time frame: Up to approximately 3 days]
Eligibility criteria
Inclusion criteria
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Body weight ˃ 45 kg at the time of screening and upon initial confinement.
- 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 suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, , in the opinion of the investigator, could compromise either participant safety or the results of the trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Acpru /Id# 279405 — Grayslake
Identifiers
NCT: NCT07222709 · M25-818