Chronic Hepatitis CPhase 1NCT01144936
Study of VX-985 in Subjects With Chronic Hepatitis C
A Phase 1 study of Chronic Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 3 sites in United States.
Trial summary
The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of VX-985. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Hepatitis C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who are male or females of non-childbearing potential aged 18 to 64 years(inclusive) with a body mass index (BMI) between 18 and 32 (kg/m2)
- Certain subjects must agree to use acceptable contraceptive methods as specified in protocol
- Subjects who are treatment naïve and are infected with genotype 1 chronic hepatitis C
- Subjects must be in good health and have normal laboratory values as judged by investigator
- Subjects must not have clinically significant abnormal results for physical examination
Who cannot join
- Subjects must not have received approved or experimental HCV therapy
- Subjects must not have evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
- Subjects must not have any known history of other cause of significant liver disease including hepatitis B, drug or alcohol-related cirrhosis, etc
- Subjects must not be diagnosed with or have suspected hepatocellular carcinoma
- Subjects must not have histologic evidence of hepatic cirrhosis on any liver biopsy or test capable of detecting cirrhosis within the past 2 years
- Subjects with a known history or other evidence of severe retinopathy or clinically significant ophthalmological disorder
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- Subjects must not have a history of any illness that might confound the results of the study or pose an additional risk in administering study drug(s) to the subject e.g. history of cardiovascular or central nervous system disease, ongoing psychiatric disorder, poorly controlled diabetes, etc
- Subject must not have taken any of the prohibited medications within the specified time before study start or take certain medications (including herbal supplements) during the study
- Subjects must not have a history of drug or alcohol abuse or addiction within 6 months before the start of dosing, or test positive for alcohol or drugs of abuse
- Subjects must not have donated or had a significant loss of blood within 56 days of the start of dosing, or donated more than 1 unit of plasma within 7 days before the start of dosing
- Subjects must not consume excessive amounts of caffeine
- Subjects must not have participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months
- Subjects who are female and have a positive pregnancy test and/or who are considered to be of childbearing potential or are nursing.
- Subjects that have a female partner who is pregnant, nursing, or planning to become pregnant during the study or shortly after the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Maryland
Baltimore, Maryland
Kansas
Overland Park, Kansas
Washington
Tacoma, Washington
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of VX-985 in Subjects With Genotype 1 Chronic Hepatitis C
The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of VX-985.
- Conditions
- Chronic Hepatitis C
- Being tested
- VX-985 or matching placebo
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-985 or matching placeboDrug
low dose
VX-985 or matching placeboDrug
high dose
VX-985 or matching placeboDrug
dose TBD
| Study group | Role | What they receive |
|---|---|---|
| Panel 1: VX-985 Dose 1 | Experimental | Not described Receives: Drug: VX-985 or matching placebo |
| Panel 2: VX-985 Dose 2 | Experimental | Not described Receives: Drug: VX-985 or matching placebo |
| Panel 3: VX-985 Dose 3 | Experimental | Not described Receives: Drug: VX-985 or matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events)
Measured: 10-13 days
Secondary outcomes (2)
Plasma pharmacokinetic parameters of VX-985
Measured: 10-13 days
HCV RNA levels
Measured: 5-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJun 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 Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lisa Mahnke, MD, PhD, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144936
- Sponsor's protocol ID
- VX09-985-101
- Status last verified
- Mar 2011
- First submitted
- 14 Jun 2010
- Last updated
- 9 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of VX-985 in Subjects With Genotype 1 Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01144936
- Acronym / sponsor ID
- VX09-985-101
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Jun 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.
The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of VX-985.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panel 1: VX-985 Dose 1 | Experimental | Drug: VX-985 or matching placebo |
| Panel 2: VX-985 Dose 2 | Experimental | Drug: VX-985 or matching placebo |
| Panel 3: VX-985 Dose 3 | Experimental | Drug: VX-985 or matching placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who are male or females of non-childbearing potential aged 18 to 64 years(inclusive) with a body mass index (BMI) between 18 and 32 (kg/m2)
- Certain subjects must agree to use acceptable contraceptive methods as specified in protocol
- Subjects who are treatment naïve and are infected with genotype 1 chronic hepatitis C
- Subjects must be in good health and have normal laboratory values as judged by investigator
- Subjects must not have clinically significant abnormal results for physical examination
Key exclusion criteria (14 listed)
- Subjects must not have received approved or experimental HCV therapy
- Subjects must not have evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
- Subjects must not have any known history of other cause of significant liver disease including hepatitis B, drug or alcohol-related cirrhosis, etc
- Subjects must not be diagnosed with or have suspected hepatocellular carcinoma
- Subjects must not have histologic evidence of hepatic cirrhosis on any liver biopsy or test capable of detecting cirrhosis within the past 2 years
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 |
|---|---|---|
| VX-985 or matching placebolow dose | Drug | Panel 1: VX-985 Dose 1 |
| VX-985 or matching placebohigh dose | Drug | Panel 2: VX-985 Dose 2 |
| VX-985 or matching placebodose TBD | Drug | Panel 3: VX-985 Dose 3 |
Primary outcome
Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events)
Time frame: 10-13 days
2 secondary outcomes
Plasma pharmacokinetic parameters of VX-985
Time frame: 10-13 days
HCV RNA levels
Time frame: 5-7 months
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 9 Mar 2011.
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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.
Lisa Mahnke, MD, PhD study director
Vertex Pharmaceuticals Incorporated
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Chronic Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 3 sites 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 5 inclusion and 14 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 9 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events) (time frame: 10-13 days). 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 9 Mar 2011.