Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects

HCV Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696904
• Other study ID #: M10-351
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2008
• Last updated: November 17, 2017
• Start date: June 2008

Study information

• Verified date: September 2010
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333 in healthy volunteers and the antiviral activity in HCV infected subjects.

Description:

Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Main Selection Criteria for Healthy Volunteers:

• Subject has provided written consent.

• Subject is in general good health.

• If female, subject is postmenopausal.

• If female, subject is not pregnant and is not breast-feeding.

• Main Selection Criteria for HCV+ Subjects:

• Subject is HAV-IgM, HBsAg or HIV Ab negative.

• Subject is HCV genotype 1 with HCV RNA of > 50,000 IU/mL.

• Subject is excluded if they have previously received antiviral therapy for HCV infection

• Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment

• Subjects must have a prior liver biopsy with histology consistent with HCV induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.

Exclusion Criteria:

See above for main selection criteria

Related Conditions & MeSH terms

• HCV Infection

Intervention

Drug:
• ABT-333
Capsule, see arms for intervention description
• Placebo
Capsule, see arms for intervention description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

Mensing S, Polepally AR, König D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined An — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.		approximately 1 week or less
Primary	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.		approximately 1 week
Secondary	Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.		approximately 1 week