HCV InfectionPhase 1NCT00696904
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
A Phase 1 study testing ABT-333 in people with HCV Infection, run by AbbVie.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HCV Infection
- What is being tested?
- ABT-333
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Feb 2009
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- See above for main selection criteria
About this study
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.
Read the detailed 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.
- Conditions
- HCV Infection
- Being tested
- ABT-333, Placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-333Drug
Capsule, see arms for intervention description
PlaceboDrug
Capsule, see arms for intervention description
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose Receives: Drug: ABT-333; Drug: Placebo |
| 2 | Other | HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID Receives: Drug: ABT-333; Drug: Placebo |
| 3 | Other | Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect Receives: Drug: ABT-333 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
Measured: 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.
Measured: approximately 1 week
Secondary outcomes (1)
Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.
Measured: approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696904
- Sponsor's protocol ID
- M10-351
- Status last verified
- Sep 2010
- First submitted
- 11 Jun 2008
- Last updated
- 21 Nov 2017
- Results posted
- No
Publications
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.
PubMed 26597291