Hepatitis CPhase 1NCT01010906
A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)
A Phase 1 study testing Vaniprevir 300 mg and Vaniprevir 200 mg in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Vaniprevir 300 mg and Vaniprevir 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2009to 21 Jun 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hepatic Participants:
- Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
- Apart from hepatic insufficiency, is in good general health
- Has a diagnosis of chronic stable hepatic insufficiency
- Score on the Child-Pugh scale ranged from 5 to 6 (mild hepatic insufficiency); from 7 to 9 (moderate hepatic insufficiency); from 10 to 15 (severe hepatic insufficiency). Moderate and Severe participants must have had a 50% score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, prothrombin time, bilirubin) at the prestudy visit.
- Healthy Matched Participants:
- Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
- Is in good health
Who cannot join
- Female is pregnant, lactating, expecting to become pregnant or donate eggs
- Has a history of stroke or seizures
- Has a history of cancer
- Is unable to refrain from the use of any prescription or non-prescription medication
- Consumes excessive amounts of alcohol or caffeinated beverages daily
- Has had surgery, donated blood or participated in another investigational study with in the last 4 weeks
- Is a regular user or past abuser of any illicit drug including alcohol
About this study
Official title: An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-7009
This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.
- Conditions
- Hepatitis C
- Being tested
- Vaniprevir 300 mg, Vaniprevir 200 mg
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaniprevir 300 mgDrug
Also called MK-7009
single dose administration of 300 mg oral tablet
Vaniprevir 200 mgDrug
Also called MK-7009
single dose administration of 200 mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Mild Hepatic Insufficiency (HI) | Experimental | Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir Receives: Drug: Vaniprevir 300 mg |
| Healthy Control to Mild HI | Experimental | Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir Receives: Drug: Vaniprevir 300 mg |
| Moderate HI | Experimental | Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir Receives: Drug: Vaniprevir 300 mg |
| Healthy Control to Moderate HI | Experimental | Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir Receives: Drug: Vaniprevir 300 mg |
| Severe HI | Experimental | Participants with severe HI administered a single 200 mg oral tablet of vaniprevir Receives: Drug: Vaniprevir 200 mg |
| Healthy Control to Severe HI | Experimental | Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir Receives: Drug: Vaniprevir 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration
Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.
Measured: 0-48 hours postdose
Secondary outcomes (1)
Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration
Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.
Measured: 0-48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study start1 Jul 2009
- Primary completion11 Jun 2010
- Study completion21 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010906
- Sponsor's protocol ID
- 7009-005
- Other IDs
- 2009_674
- Status last verified
- Sep 2018
- First submitted
- 6 Nov 2009
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-7009
- ClinicalTrials.gov ID
- NCT01010906
- Acronym / sponsor ID
- 7009-005
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 11 Jun 2010 (actual)
- Study completion
- 21 Jun 2010 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Posted 29 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Mild Hepatic Insufficiency (HI) | Experimental | Drug: Vaniprevir 300 mgParticipants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir |
| Healthy Control to Mild HI | Experimental | Drug: Vaniprevir 300 mgHealthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir |
| Moderate HI | Experimental | Drug: Vaniprevir 300 mgParticipants with moderate HI administered a single 300 mg oral tablet of vaniprevir |
| Healthy Control to Moderate HI | Experimental | Drug: Vaniprevir 300 mgHealthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir |
| Severe HI | Experimental | Drug: Vaniprevir 200 mgParticipants with severe HI administered a single 200 mg oral tablet of vaniprevir |
| Healthy Control to Severe HI | Experimental | Drug: Vaniprevir 200 mgHealthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
- Apart from hepatic insufficiency, is in good general health
- Has a diagnosis of chronic stable hepatic insufficiency
- Score on the Child-Pugh scale ranged from 5 to 6 (mild hepatic insufficiency); from 7 to 9 (moderate hepatic insufficiency); from 10 to 15 (severe hepatic insufficiency). Moderate and Severe participants must have had a 50% score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, prothrombin time, bilirubin) at the prestudy visit.
- Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
Key exclusion criteria (7 listed)
- Female is pregnant, lactating, expecting to become pregnant or donate eggs
- Has a history of stroke or seizures
- Has a history of cancer
- Is unable to refrain from the use of any prescription or non-prescription medication
- Consumes excessive amounts of alcohol or caffeinated beverages daily
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 |
|---|---|---|
| Vaniprevir 300 mgAlso: MK-7009single dose administration of 300 mg oral tablet | Drug | Healthy Control to Mild HI, Healthy Control to Moderate HI, Mild Hepatic Insufficiency (HI), Moderate HI |
| Vaniprevir 200 mgAlso: MK-7009single dose administration of 200 mg oral tablet | Drug | Healthy Control to Severe HI, Severe HI |
Primary outcome
Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration
Time frame: 0-48 hours postdose
Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.
1 secondary outcome
Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration
Time frame: 0-48 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaniprevir 300 mg and Vaniprevir 200 mg in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
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 8 inclusion and 7 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 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 29 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration (time frame: 0-48 hours postdose). 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 Oct 2018.