Clinical Trials in the USA / NCT07856706
Starting soon
Phase 1
A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults
NCT07856706 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Subjects
Investigational drug(s) / intervention(s)
ABBV-7828Placebo for ABBV-7828
ABBV-7828: Oral administration
Placebo for ABBV-7828: Oral administration
Study summary
This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants.
Eligibility
Inclusion Criteria:
* Individuals between 18 to 65 years of age at the time of screening.
* BMI is \<= 18.0 to \>= 32.0 kg/m2.
* A condition of general good health, based upon the results of a medical history, physical evaluations, 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.
* Has any clinically significant ECG abnormalities including the following:
* Evidence of 2nd or 3rd degree atrial ventricular (AV) block at screening visit or upon initial confinement
* QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) \> 450 msec (males) or \> 460 msec (females) at screening visit or upon initial confinement.
* 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.
Primary outcome measure(s)
- Number of Participants with Adverse Events (AEs) — Up to approximately 38 days
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. - Maximum Observed Serum Concentration (Cmax) of ABBV-7828 — Up to approximately 10 days
Cmax of ABBV-7828 - Time to Cmax (Tmax) of ABBV-7828 — Up to approximately 10 days
Time to Cmax (Tmax) of ABBV-7828 - Terminal Phase Elimination Rate Constant (Beta) of ABBV-7828 — Up to approximately 10 days
Beta of ABBV-7828 - Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-7878 — Up to approximately 10 days
AUCt of ABBV-7878 - AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-7878 — Up to approximately 10 days
AUCinf of ABBV-7878
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Acpru /Id# 283545 | Grayslake | Illinois |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07856706 on ClinicalTrials.gov ↗ ← All trials in the USA