Hepatitis C, Chronic, Healthy VolunteerPhase 1NCT01181024
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
A Phase 1 study testing RO5303253 in people with Hepatitis C, Chronic, Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
Trial summary
This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic, Healthy Volunteer
- What is being tested?
- RO5303253
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteNew Zealand
- Study dates
- Apr 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers or patients with chronic hepatitis C genotype 1, 18 to 60 years of age
- Patients must be treatment-naïve for antiviral therapy for chronic hepatitis C with interferon based therapy
- Body mass index (BMI) 18 - 32 kg/m2 inclusive, minimum weight 45 kg
- Females must be surgically sterile or menopausal
- Male subjects and their partners of childbearing potential must use 2 methods of contraception throughout the study and for 70 days after the last dose
Who cannot join
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Women with reproductive potential
- Positive for hepatitis B or HIV (or hepatitis C for healthy volunteers) at screening
- For hepatitis C patients: decompensated liver disease or impaired liver function, evidence of cirrhosis documented at any time, presence or history of non-hepatitis C chronic liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Ascending Dose Tolerability and Pharmacokinetic Study of RO5303253 With a Pilot Food-effect Investigation in Healthy Subjects and Exploratory Pharmacokinetic, Pharmacodynamic, and Safety Assessments in Chronic Hepatitis C Genotype 1 Patients Following 5 Days of Oral Administration
This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.
- Conditions
- Hepatitis C, Chronic, Healthy Volunteer
- Being tested
- Placebo, RO5303253
- Medical subject headings
- Hepatitis C, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)
RO5303253Drug
Cohorts receiving single ascending doses
RO5303253Drug
Single dose
RO5303253Drug
Multiple doses
| Study group | Role | What they receive |
|---|---|---|
| A: HV ascending dose | Experimental | Not described Receives: Drug: Placebo; Drug: RO5303253 |
| B: HV food effect | Experimental | Not described Receives: Drug: Placebo; Drug: RO5303253 |
| C: Hepatitis C | Experimental | Not described Receives: Drug: Placebo; Drug: RO5303253 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure
Measured: approximately 6 months
Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713
Measured: approximately 6 months
Secondary outcomes (2)
Effect of food intake on pharmacokinetics in healthy volunteers
Measured: Days 1-4
Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients
Measured: From baseline to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, Chronic, Healthy VolunteerStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181024
- Sponsor's protocol ID
- PP25195
- Other IDs
- 2009-018183-96, 2009
- Status last verified
- Nov 2016
- First submitted
- 12 Aug 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose Tolerability and Pharmacokinetic Study of RO5303253 With a Pilot Food-effect Investigation in Healthy Subjects and Exploratory Pharmacokinetic, Pharmacodynamic, and Safety Assessments in Chronic Hepatitis C Genotype 1 Patients Following 5 Days of Oral Administration
- ClinicalTrials.gov ID
- NCT01181024
- Acronym / sponsor ID
- PP25195
- Conditions
- Hepatitis C, Chronic, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: HV ascending dose | Experimental | Drug: Placebo, Drug: RO5303253 |
| B: HV food effect | Experimental | Drug: Placebo, Drug: RO5303253 |
| C: Hepatitis C | Experimental | Drug: Placebo, Drug: RO5303253 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers or patients with chronic hepatitis C genotype 1, 18 to 60 years of age
- Patients must be treatment-naïve for antiviral therapy for chronic hepatitis C with interferon based therapy
- Body mass index (BMI) 18 - 32 kg/m2 inclusive, minimum weight 45 kg
- Females must be surgically sterile or menopausal
- Male subjects and their partners of childbearing potential must use 2 methods of contraception throughout the study and for 70 days after the last dose
Key exclusion criteria (4 listed)
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Women with reproductive potential
- Positive for hepatitis B or HIV (or hepatitis C for healthy volunteers) at screening
- For hepatitis C patients: decompensated liver disease or impaired liver function, evidence of cirrhosis documented at any time, presence or history of non-hepatitis C chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebomatching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C) | Drug | A: HV ascending dose, B: HV food effect, C: Hepatitis C |
| RO5303253Cohorts receiving single ascending doses | Drug | A: HV ascending dose |
| RO5303253Single dose | Drug | B: HV food effect |
| RO5303253Multiple doses | Drug | C: Hepatitis C |
Primary outcome
Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure
Time frame: approximately 6 months
Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713
Time frame: approximately 6 months
2 secondary outcomes
Effect of food intake on pharmacokinetics in healthy volunteers
Time frame: Days 1-4
Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients
Time frame: From baseline to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5303253 in people with Hepatitis C, Chronic, Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure (time frame: approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.