Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-1354
Brief summary
This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.
Interventions
DRUGABBV-1354
Oral solution
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male participants are eligible to participate if they agree to the following from Study Day 1 and for at least 93 days after the last dose of study treatment: * Refrain from donating sperm PLUS, either: \- Practice true abstinence, defined as: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable. OR * Use a male condom with spermicide (even with a successful vasectomy) with female partner who also uses a highly effective contraceptive method with a failure rate of \< 1% per year (when used consistently and correctly). AND * Advise of the benefit for a female partner to use a highly effective method of contraception (as a condom may break or leak) if having sexual intercourse with a woman of childbearing potential who is not currently pregnant. * 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. * 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 epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic 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 \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to approximately 32 days | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
| Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements | Up to approximately 15 days | Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed. |
| Change From Baseline in Electrocardiograms (ECGs) | Up to approximately 15 days | 12-lead resting ECG will be recorded. |
| Number of Participants with Abnormal Change in Physical Examinations | Up to approximately 15 days | Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed. |
| Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed | Up to approximately 15 days | Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed. |
| Maximum observed concentration (Cmax) of ABBV-1354 | Up to approximately 15 days | Cmax of ABBV-1354 will be assessed. |
| Time to Cmax (peak time, Tmax) of ABBV-1354 | Up to approximately 15 days | Max of ABBV-1354 will be assessed. |
| Terminal phase elimination half-life (t1/2) of ABBV-1354 | Up to approximately 15 days | Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed. |
| Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-1354 | Up to approximately 15 days | AUCt of ABBV-1354 will be assessed. |
| Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-1354 | Up to approximately 15 days | AUCinf of ABBV-1354 will be assessed. |
| Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) | Up to approximately 15 days | Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed. |
| Percent of ABBV-1354 excreted in the urine | Up to approximately 15 days | Percent excreted = 100 × (Aeu/dose). |
| Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) | Up to approximately 15 days | Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed. |
| Percent of ABBV-1354 radioactivity excreted in the feces | Up to approximately 15 days | Percent excreted = 100 × (Aeu/dose). |
Countries
United States
Outcome results
None listed