Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01181427 | Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects | PHASE1 | COMPLETED | 137 | — | — | Aug 1, 2010 | Jan 1, 2012 | Jan 24, 2012 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD) | PLACEBO_COMPARATOR | Healthy volunteers, receiving single ascending doses of ABT-267 or placebo. |
| Multiple Ascending Dose (MAD) | PLACEBO_COMPARATOR | Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor. |
| Food Effect (FE) | ACTIVE_COMPARATOR | Healthy volunteers, receiving ABT-267, multi-dose, food effect. |
| Antiviral Activity | PLACEBO_COMPARATOR | HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days. |
| Resistance Monitoring | NO_INTERVENTION | HCV genotype 1-infected treatment naïve subjects, receiving at least one dose of ABT-267 or placebo in the "Antiviral Activity" arm, follow-up to monitor resistance developed to ABT-267, no treatment and only blood samples will be collected |
| Name | Type | Description |
|---|---|---|
| ABT-267 | DRUG | See arm description |
| Placebo | DRUG | See arms description |
| Blood Sample Collection | PROCEDURE | See arm description |
| Cytochrome P450 inhibitor | DRUG | See arm description |
Inclusion Criteria Main Selection Criteria for Healthy Volunteers: * Subject has provided written consent. * Subject is in general good health. * Females must be post-menopausal for at least 2 years or surgically sterile. * Females must not be pregnant or breast-feeding. If male, subject is surgic...