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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003685-14 | EudraCT Number |
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A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in combination with each other and Ritonavir(r).
Absolute bioavailability of ABT-267 and ABT-450 in the body when given together
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Regimen A | Experimental | 8 Subjects in Group I - Regimen A: ABT-450/r/ABT-267 |
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| Group 2 - Regimen B | Experimental | 8 Subjects in Group II - Regimen B: ABT-450/r/ABT-267 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450/r/ABT-267 | Drug | ABT-450, ABT-267 and ritonavir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability | dose normalized AUC(0-inf) for oral dose/dose normalized AUC(0-inf) for IV dose | Day 1 until 72 hours after single dose of ABT-450/r/ABT-267 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Labs | Chemistry, Haematology, Urinalysis | Day -1 until 72 hours after single dose of ABT-450/r/ABT-267 |
| Electrocardiograms (ECGs) | The measure of any change in 12 lead electrocardiogram from Day-1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armen Asatryan, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 118615 | Nottingham | NG11 6JS | United Kingdom |
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| Day-1 until 24 hours after single dose of ABT-450/r/ABT-267 |
| Number of participants with adverse events | Screening until 7 days after single dose of ABT-450/r/ABT-267 |
| Physical Exam | To examine any change from Day-1 in the subject's physical presentation (body temperature, blood pressure, pulse) | Day-1 until 72 hours after single dose ABT-450/r/ABT-267 |