Healthy VolunteerPhase 1NCT01697436
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
A Phase 1 study testing ribavirin [Copegus] in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
This four-period, single-center, open-label, single-dose, randomized, cross-over study will assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a Copegus tablet in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ribavirin [Copegus]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult healthy volunteers
- Able to participate and willing to give informed consent and comply with the study restrictions.
- Negative urine pregnancy test (for women of childbearing potential) documented at screening and within the 24-hour period prior to each dose of test drug
- All male subjects with female partners of childbearing potential must agree to use two reliable forms of contraception, one of which must be a physical barrier method, during the study and for 6 months thereafter
- Female subjects must be postmenopausal or surgically sterile or they must agree to use two reliable forms of contraception one of which must be a physical barrier method, during treatment and for 6 months thereafter
- Body mass index (BMI) <30 kg/m2
Who cannot join
- Pregnant or lactating women and male partners of females who are pregnant or lactating
- Positive test for drugs of abuse at screening and within the 24-hour period prior to each dose of test drug.
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average (1 standard unit = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before screening and from at least 48 hours before Day -1 through the end of the study
- Confirmed systolic blood pressure (SBP) > 140 or < 90 mm Hg, and diastolic blood pressure (DBP) > 90 or < 50 mm Hg
- Resting pulse rate > 90 or < 45 beats per minute
- History or symptoms of any significant disease including (but not limited to) hematological, neurological, psychiatric, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder
Show all 17Show fewer
- History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma of the skin (e.g., skin basal or squamous cell carcinoma)
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
- Use of any medications (prescription or over-the-counter, vitamin, mineral, herbal, and dietary supplements within 7 days, or less than 5 half-lives (whichever is longer) prior to randomization. Exceptions are acetaminophen (up to 2 g/day), ibuprofen (up to 1 g/day), and hormonal contraceptives.
- Clinically significant abnormalities in laboratory test results
- Participation in an investigational drug study within 60 days or in an investigational device study within 30 days prior to screening
- Donation of blood over 500 mL from 3 months prior to screening until the end of the study; donation of plasma from 7 days prior to screening until the end of the study
- Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study
- Smoker of more than 10 cigarettes per day prior to screening or use of tobacco products equivalent to more than 10 cigarettes per day
- Clinically significant abnormalities in the pre-dose resting electrocardiograms
- Any confirmed significant allergic reactions against RBV or known or potential allergy or hypersensitivity to the non-active ingredients of the study drugs (non-active hay fever is acceptable)
- Individuals receiving ribavirin therapy within 6 months prior to study initiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bioequivalence Study of Ribavirin Oral Solution (RO0209963) Versus the Reference Ribavirin Tablets (Copegus) Following Oral Administration in Healthy Adult Subjects
This four-period, single-center, open-label, single-dose, randomized, cross-over study will assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four sequences in which they will receive the treatment under fed and under fasted conditions.
- Conditions
- Healthy Volunteer
- Being tested
- ribavirin [Copegus]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ribavirin [Copegus]Drug
tablet under fed condition
ribavirin [Copegus]Drug
tablet under fasted condition
ribavirin [Copegus]Drug
oral solution under fed condition
ribavirin [Copegus]Drug
oral solution under fasted condition
| Study group | Role | What they receive |
|---|---|---|
| Crossover Period 1 | Experimental | Not described Receives: Drug: ribavirin [Copegus] |
| Crossover Period 2 | Experimental | Not described Receives: Drug: ribavirin [Copegus] |
| Crossover Period 3 | Experimental | Not described Receives: Drug: ribavirin [Copegus] |
| Crossover Period 4 | Experimental | Not described Receives: Drug: ribavirin [Copegus] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: area under the plasma concentration time curve
Measured: Periods 1-4: Predose and up to 192 hours post-dose
Pharmacokinetics: maximum plasma concentration
Measured: Periods 1-4: Predose and up to 192 hours post-dose
Secondary outcomes (1)
Safety: incidence of adverse events
Measured: Approximately 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT01697436
- Sponsor's protocol ID
- BP28307
- Status last verified
- Nov 2016
- First submitted
- 28 Sep 2012
- 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 Bioequivalence Study of Ribavirin Oral Solution (RO0209963) Versus the Reference Ribavirin Tablets (Copegus) Following Oral Administration in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01697436
- Acronym / sponsor ID
- BP28307
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Oct 2012 (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 four-period, single-center, open-label, single-dose, randomized, cross-over study will assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four sequences in which they will receive the treatment under fed and under fasted conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Crossover Period 1 | Experimental | Drug: ribavirin [Copegus] |
| Crossover Period 2 | Experimental | Drug: ribavirin [Copegus] |
| Crossover Period 3 | Experimental | Drug: ribavirin [Copegus] |
| Crossover Period 4 | Experimental | Drug: ribavirin [Copegus] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult healthy volunteers
- Able to participate and willing to give informed consent and comply with the study restrictions.
- Negative urine pregnancy test (for women of childbearing potential) documented at screening and within the 24-hour period prior to each dose of test drug
- All male subjects with female partners of childbearing potential must agree to use two reliable forms of contraception, one of which must be a physical barrier method, during the study and for 6 months thereafter
- Female subjects must be postmenopausal or surgically sterile or they must agree to use two reliable forms of contraception one of which must be a physical barrier method, during treatment and for 6 months thereafter
Key exclusion criteria (17 listed)
- Pregnant or lactating women and male partners of females who are pregnant or lactating
- Positive test for drugs of abuse at screening and within the 24-hour period prior to each dose of test drug.
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average (1 standard unit = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before screening and from at least 48 hours before Day -1 through the end of the study
- Confirmed systolic blood pressure (SBP) > 140 or < 90 mm Hg, and diastolic blood pressure (DBP) > 90 or < 50 mm Hg
- Resting pulse rate > 90 or < 45 beats per minute
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 |
|---|---|---|
| ribavirin [Copegus]tablet under fed condition | Drug | Crossover Period 1 |
| ribavirin [Copegus]tablet under fasted condition | Drug | Crossover Period 2 |
| ribavirin [Copegus]oral solution under fed condition | Drug | Crossover Period 3 |
| ribavirin [Copegus]oral solution under fasted condition | Drug | Crossover Period 4 |
Primary outcome
Pharmacokinetics: area under the plasma concentration time curve
Time frame: Periods 1-4: Predose and up to 192 hours post-dose
Pharmacokinetics: maximum plasma concentration
Time frame: Periods 1-4: Predose and up to 192 hours post-dose
1 secondary outcome
Safety: incidence of adverse events
Time frame: Approximately 16 weeks
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.
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Screening Protocol
Pain
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 ribavirin [Copegus] in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
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 6 inclusion and 17 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 United States. 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?
Pharmacokinetics: area under the plasma concentration time curve (time frame: Periods 1-4: Predose and up to 192 hours post-dose). 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.