A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults
ConditionHealthy Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbbVie
About this trial
This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
ABBV-7828
DrugOral administration
Placebo for ABBV-7828
DrugOral administration
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Part 1: ABBV-7828Experimental treatment 1 intervention
Group B: Part 1: PlaceboPlacebo comparator 1 intervention
Group C: Part 2: ABBV-7828 Sequence 1Experimental treatment 1 intervention
Group D: Part 2: ABBV-7828 Sequence 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events (AEs)
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.
Time frame
Up to approximately 38 days2
Maximum Observed Serum Concentration (Cmax) of ABBV-7828
Cmax of ABBV-7828
Time frame
Up to approximately 10 days3
Time to Cmax (Tmax) of ABBV-7828
Time to Cmax (Tmax) of ABBV-7828
Time frame
Up to approximately 10 days4
Terminal Phase Elimination Rate Constant (Beta) of ABBV-7828
Beta of ABBV-7828
Time frame
Up to approximately 10 days Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: