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This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-1354 | Experimental | Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-1354 | Drug | Oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | 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. | Up to approximately 32 days |
| Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements | Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed. | Up to approximately 15 days |
| Change From Baseline in Electrocardiograms (ECGs) | 12-lead resting ECG will be recorded. | Up to approximately 15 days |
| Number of Participants with Abnormal Change in Physical Examinations | Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed. | Up to approximately 15 days |
| Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed | Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed. | Up to approximately 15 days |
| Maximum observed concentration (Cmax) of ABBV-1354 | Cmax of ABBV-1354 will be assessed. | Up to approximately 15 days |
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Inclusion Criteria:
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
AND
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc /ID# 277011 | Madison | Wisconsin | 53704 | United States |
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| Time to Cmax (peak time, Tmax) of ABBV-1354 |
Max of ABBV-1354 will be assessed. |
| Up to approximately 15 days |
| Terminal phase elimination half-life (t1/2) of ABBV-1354 | Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed. | Up to approximately 15 days |
| Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-1354 | AUCt of ABBV-1354 will be assessed. | Up to approximately 15 days |
| Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-1354 | AUCinf of ABBV-1354 will be assessed. | Up to approximately 15 days |
| Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) | Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed. | Up to approximately 15 days |
| Percent of ABBV-1354 excreted in the urine | Percent excreted = 100 × (Aeu/dose). | Up to approximately 15 days |
| Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) | Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed. | Up to approximately 15 days |
| Percent of ABBV-1354 radioactivity excreted in the feces | Percent excreted = 100 × (Aeu/dose). | Up to approximately 15 days |