Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

AbbVie

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: ritonavir; Drug: Placebo for ritonavir; Drug: ABT-450; Drug: placebo for ABT-450

Study type: Interventional

Funder types: Industry

Identifiers

NCT00850044

M10-749

Details and patient eligibility

About

The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.

Enrollment: 87 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• overall healthy subjects
• non-childbearing potential females included

Exclusion criteria

• history of significant sensitivity to any drug
• positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
• history of gastrointestinal issues or procedures
• history of seizures, diabetes or cancer (except basal cell carcinoma)
• clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
• use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration
• donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
• abnormal screening laboratory results that are considered clinically significant by the investigator
• current enrollment in another clinical study
• previous enrollment in this study
• recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
• pregnant or breastfeeding female
• requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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87 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

ABT-450

Treatment:

Drug: ABT-450

2

Placebo Comparator group

Description:

Placebo for ABT-450

Treatment:

Drug: placebo for ABT-450

3

Active Comparator group

Description:

ABT-450/ritonavir

Treatment:

Drug: ritonavir

Drug: ABT-450

4

Placebo Comparator group

Description:

Placebo for ABT-450/placebo for ritonavir

Treatment:

Drug: placebo for ABT-450

Drug: Placebo for ritonavir