HCV InfectionPhase 1NCT01211626
Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
A Phase 1 study testing ANA773 in people with HCV Infection, run by Hoffmann-La Roche at 3 sites in Netherlands.
Trial summary
The overall study design includes two parts, Part A and Part B. Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study. Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. 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?
- ANA773
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jun 2008to Aug 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
Part A Inclusion:
- Male or female, ages 18 to 65 years
- No clinically significant abnormalities
- No serious or severe chronic conditions
- Non-smokers
Part A Exclusion:
- Female subjects who are pregnant or breast-feeding
- History of significant medical condition that could interfere with study medication or associated study assessments
- History of or current drug or alcohol abuse
Part B Inclusion Criteria:
- Male or female, ages 18 to 65 years
- Diagnosed with chronic liver disease consistent with chronic hepatitis C infection for at least 6 months
- Screening HCV RNA ≥ 375,000 copies/mL or ≥ 75,000 IU/mL
- Naïve to or have relapsed from prior IFN-alpha based therapy
Part B Exclusion Criteria:
- Female subjects who are pregnant or breast-feeding
- Received anti-viral therapy or immunomodulatory therapy within 90 days prior to administration of the first dose of study medication
- Use of an investigational drug or participation in an investigational study with a licensed drug within 30 days
- History of significant medical condition that could interfere with study medication or associated study assessments
- History of or current drug or alcohol abuse
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Academisch Medisch Centrum (AMC)
Amsterdam
PRA Clinical Research Unit
Groningen
Erasmus MC (EMC)
Rotterdam
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study in Healthy Volunteers and Patients With Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANA773 Tosylate
The overall study design includes two parts, Part A and Part B.
Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.
Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
Read the detailed description
Study Design:
Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study.
Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
- Conditions
- HCV Infection
- Being tested
- ANA773, 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.
ANA773Drug
ANA773 Tosylate Capsule
PlaceboDrug
Matching Placebo Capsule
| Study group | Role | What they receive |
|---|---|---|
| Part A, Group 1 Healthy Volunteer | Active comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 200 mg of ANA773 (n=6) or placebo (n=2) Receives: Drug: ANA773; Drug: Placebo |
| Part A, Group 2 Healthy Volunteer | Active comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 400 mg of ANA773 (n=6) or placebo (n=2) Receives: Drug: ANA773; Drug: Placebo |
| Part A, Group 3 Healthy Volunteer | Active comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 800 mg of ANA773 (n=6) or placebo (n=2) Receives: Drug: ANA773; Drug: Placebo |
| Part A, Group 4 Healthy Volunteer | Active comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1200 mg of ANA773 (n=6) or placebo (n=2) Receives: Drug: ANA773; Drug: Placebo |
| Part A, Group 5 Healthy Volunteer | Active comparator | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1600 mg of ANA773 (n=6) or placebo (n=2) Receives: Drug: ANA773; Drug: Placebo |
| Part B, Group 6 HCV Infected Patient | Active comparator | multiple oral doses(14 administrations) every other day of 2000 mg of ANA773 (n=6) or placebo (n=2) Receives: Drug: ANA773; Drug: Placebo |
| Part B, Group 7 HCV Infected Patient | Active comparator | multiple oral doses(14 administrations) every other day of 1200 mg of ANA773 (n=6) or placebo (n=2) Receives: Drug: ANA773; Drug: Placebo |
| Part B, Group 8 HCV Infected Patient | Active comparator | multiple oral doses(14 administrations) every other day of 1600 mg of ANA773 (n=6) or placebo (n=2) Receives: Drug: ANA773; Drug: Placebo |
| Part B, Group 9 HCV Infected Patient | Active comparator | multiple oral doses(5 administrations) every other day of 2000 mg of ANA773 (n=8) or placebo (n=2) Receives: Drug: ANA773; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
Measured: Up to 41 Days
Secondary outcomes (1)
Immunological effects in both Healthy Subjects and Chronic HCV Patients
Evaluate the immunological effects and antiviral activity as assessed by changes in HCV RNA levels.
Measured: Up to 41 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211626
- Sponsor's protocol ID
- ANA773-601
- Status last verified
- Nov 2012
- First submitted
- 27 Sep 2010
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes