Healthy Volunteer
Conditions
Keywords
Healthy Volunteer
Brief summary
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-859 after single ascending doses in healthy adult volunteers.
Interventions
DRUGABBV-859
Oral Tablet
DRUGPlacebo for ABBV-859
Oral Tablet
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. * Body Mass Index (BMI) is \>= 18.0 to \<= 32 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. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
Exclusion criteria
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, endocrine, immunological, pulmonary, metabolic, neurological or psychiatric disease or disorder, or any uncontrolled medical illness. * 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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\]. * Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix. * History or evidence of active Tuberculosis disease or latent Tuberculosis infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 99 Days | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. |
| Maximum Observed Serum Concentration (Cmax) of ABBV-859 | Up to 99 Days | Cmax of ABBV-859 |
| Time to Cmax (Tmax) of ABBV-859 | Up to 99 Days | Time to Cmax (Tmax) of ABBV-859 |
| Terminal Phase Elimination Rate Constant (Beta) of ABBV-859 | Up to 99 Days | Beta of ABBV-859 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-859 | Up to 99 Days | t1/2 of ABBV-859 |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-859 | Up to 99 Days | AUCt of ABBV-859 |
| AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859 | Up to 99 Days | AUCinf of ABBV-859 |
| Apparent Clearance (CL/F) ABBV-859 | Up to 99 Days | CL/F of ABBV-859 |
| Antidrug Antibody (ADA) | Up to 99 Days | Incidence and concentration of anti-drug antibodies. |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed