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ABT-072

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Oct 25, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials4
Total Enrollment194
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01081483A Study of Single Doses of ABT-072 in Japanese Healthy Male AdultsPHASE1 COMPLETED 24 — — Mar 1, 2010 -Oct 25, 20101 Japan
NCT00982826Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072PHASE1 COMPLETED 52 — — Sep 1, 2009Jan 1, 2010Oct 21, 20101 United States
NCT00947440Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule FormulationPHASE1 COMPLETED 18 — — Jul 1, 2009 -Oct 21, 20101 United States
NCT00752687A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected AdultsPHASE1 COMPLETED 100 — — Sep 1, 2008 -Oct 21, 20101 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability assessment
Day 1 to Day 4 and Day 15.

Safety and tolerability assessment by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.

Pharmacokinetic profile evaluation
Day 1 to Day 4

Single Dose Pharmacokinetic profile evaluation

To determine the single and multiple dose safety and tolerability of the ABT-072 tablet formulation under non-fasting conditions.
Up to 14 days post last dose.
To determine the single and multiple dose safety pharmacokinetics of the ABT-072 tablet formulation under non-fasting conditions.
72 hours post last dose.
To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
4 days post each dose
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
2 weeks
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
2 weeks
Secondary Endpoints
To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation.
72 hours post last dose.
To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
Through 14 days post last dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABT-072 TabletACTIVE_COMPARATORABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3
PlaceboPLACEBO_COMPARATORPlacebo Tablet, QD, single doses, groups 1-3
1EXPERIMENTALABT-072 tablet single ascending dose
2EXPERIMENTALPlacebo tablet
3EXPERIMENTALABT-072 tablet administered under non-fasting conditions.
4EXPERIMENTALABT-072 tablet administered under fasting conditions
5EXPERIMENTALABT-072 tablet multiple ascending dose
Tablet 1 vs. CapsuleACTIVE_COMPARATORSingle dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid.
Tablet 2 vs. CapsuleACTIVE_COMPARATORSingle dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid.
Interventions
NameTypeDescription
ABT-072DRUGSee arm description for more information
PlaceboDRUGSee arm description for more information
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Eligibility Criteria
Age Range20 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overall healthy adult Japanese males Exclusion Criteria: * Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medi...

Countries:JapanUnited States
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Competitive Landscape -Hepatitis C 11 trials
CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Abbott LaboratoriesABT2 — Undisclosed
AbbVie, Inc.ABBV1 — Undisclosed
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