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

NCT00696904 | Completed Phase 1

• 1 other identifier: M10-351
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (2)

• Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.

  approximately 1 week or less

• 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 Outcomes (1)

• Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.

  approximately 1 week

Study Arms (3)

1

OTHER

Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose

Drug: ABT-333; Drug: Placebo

2

OTHER

HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID

Drug: ABT-333; Drug: Placebo

3

OTHER

Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect

Drug: ABT-333

Interventions

ABT-333 DRUG

Capsule, see arms for intervention description

1; 2; 3

Placebo DRUG

Capsule, see arms for intervention description

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• See above for main selection criteria

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Mensing S, Polepally AR, Konig 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 Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23.

  PMID: 26597291 RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

dasabuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2009
• Last Updated: November 21, 2017

Record last verified: 2010-09