Recruiting
Phase 1

ABBV-7828

Sponsor:

AbbVie

Code:

NCT07856706

Conditions

Healthy Subjects

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

ABBV-7828

Placebo for ABBV-7828

Study Details

Brief summary:

This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants.

Conditions

Healthy Subjects

Study ID

NCT07856706

Start date

Oct 2, 2026

Status verified date

Oct, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Part 1: ABBV-7828

Participants will receive single doses of ABBV-7828.

placebo comparator: Part 1: Placebo

Participants will receive single doses of placebo.

experimental: Part 2: ABBV-7828 Sequence 1

Participants will receive ABBV-7828 while in fasting in Period 1 followed by ABBV-7828 after high fat/high calorie meal in Period 2.

experimental: Part 2: ABBV-7828 Sequence 2

Participants will receive ABBV-7828 after a high-fat/high calorie meal in Period 1 followed by ABBV-7828 in fasting conditions in Period 2.

Interventions

ABBV-7828

Oral administration

Placebo for ABBV-7828

Oral administration

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 38 days ]
  • Maximum Observed Serum Concentration (Cmax) of ABBV-7828 [ Time Frame: Up to approximately 10 days ]
  • Time to Cmax (Tmax) of ABBV-7828 [ Time Frame: Up to approximately 10 days ]
  • Terminal Phase Elimination Rate Constant (Beta) of ABBV-7828 [ Time Frame: Up to approximately 10 days ]
  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-7878 [ Time Frame: Up to approximately 10 days ]
  • AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-7878 [ Time Frame: Up to approximately 10 days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Acpru /Id# 283545

Recruiting

Grayslake, Illinois, United States, 60030

More Information

Sponsor

AbbVie

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • Healthy Adult Subjects
  • ABBV-7828

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.