Hepatitis CPhase 1NCT00998985
A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
A Phase 1 study testing Grazoprevir in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Grazoprevir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2010to 8 Nov 2012
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Baseline health is stable.
- Has a clinical diagnosis of chronic HCV infection.
Who cannot join
- Has a history of stroke or chronic seizures.
- Has a history of cancer.
- Has a history of human immunodeficiency virus (HIV) infection.
- Has had major surgery, donated blood or participated in another investigational study within the past 3 months.
About this study
Official title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Grazoprevir (MK-5172) in Hepatitis C Infected Male Patients
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.
- Conditions
- Hepatitis C
- Being tested
- Grazoprevir, 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.
GrazoprevirDrug
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
PlaceboDrug
Placebo tablet, orally, once a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 400 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 600 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 800 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 400 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 600 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 800 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 200 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 100 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 50 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 200 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 100 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 50 mg Grazoprevir - GT3 | Experimental | GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 30 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
| 10 mg Grazoprevir - GT1 | Experimental | GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo Receives: Drug: Grazoprevir; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical and Laboratory Adverse Events (AEs)
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Measured: All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)
Secondary outcomes (4)
Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7
Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr.
Measured: Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7
Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM.
Measured: Day 7 at 24 hours post-dose
Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo
Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL.
Measured: Baseline and up to approximately 2 months
Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo
Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA.
Measured: Baseline and up to approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study start23 Feb 2010
- Primary completion8 Nov 2012
- Study completion8 Nov 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 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
- NCT00998985
- Sponsor's protocol ID
- 5172-004
- Other IDs
- 2009_678, 2009-015563-13, 2009
- Status last verified
- Jun 2018
- First submitted
- 20 Oct 2009
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf
Publications
Yeh WW, Fraser IP, Jumes P, Petry A, Lepeleire I, Robberechts M, Reitmann C, Van Dyck K, Huang X, Guo Z, Panebianco D, Nachbar RB, O'Mara E, Wagner JA, Butterton JR, Dutko FJ, Moiseev V, Kobalava Z, Huser A, Visan S, Schwabe C, Gane E, Popa S, Ghicavii N, Uhle M, Wagner F. Antiviral Activity, Safety, and Tolerability of Multiple Ascending Doses of Elbasvir or Grazoprevir in Participants Infected With Hepatitis C Virus Genotype-1 or -3. Clin Ther. 2018 May;40(5):704-718.e6. doi: 10.1016/j.clinthera.2018.03.002. Epub 2018 Apr 25.
PubMed 29703432
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Grazoprevir (MK-5172) in Hepatitis C Infected Male Patients
- ClinicalTrials.gov ID
- NCT00998985
- Acronym / sponsor ID
- 5172-004
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2010 (actual)
- Primary completion
- 8 Nov 2012 (actual)
- Study completion
- 8 Nov 2012 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Posted 2 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| 400 mg Grazoprevir - GT1 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo |
| 600 mg Grazoprevir - GT1 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo |
| 800 mg Grazoprevir - GT1 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo |
| 400 mg Grazoprevir - GT3 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo |
| 600 mg Grazoprevir - GT3 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo |
| 800 mg Grazoprevir - GT3 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo |
| 200 mg Grazoprevir - GT1 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo |
| 100 mg Grazoprevir - GT1 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo |
| 50 mg Grazoprevir - GT1 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo |
| 200 mg Grazoprevir - GT3 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo |
| 100 mg Grazoprevir - GT3 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo |
| 50 mg Grazoprevir - GT3 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo |
| 30 mg Grazoprevir - GT1 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo |
| 10 mg Grazoprevir - GT1 | Experimental | Drug: Grazoprevir, Drug: PlaceboGT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Baseline health is stable.
- Has a clinical diagnosis of chronic HCV infection.
Key exclusion criteria (4 listed)
- Has a history of stroke or chronic seizures.
- Has a history of cancer.
- Has a history of human immunodeficiency virus (HIV) infection.
- Has had major surgery, donated blood or participated in another investigational study within the past 3 months.
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 |
|---|---|---|
| Grazoprevir10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days | Drug | 10 mg Grazoprevir - GT1, 100 mg Grazoprevir - GT1, 100 mg Grazoprevir - GT3, 200 mg Grazoprevir - GT1, 200 mg Grazoprevir - GT3, 30 mg Grazoprevir - GT1, 400 mg Grazoprevir - GT1, 400 mg Grazoprevir - GT3, 50 mg Grazoprevir - GT1, 50 mg Grazoprevir - GT3, 600 mg Grazoprevir - GT1, 600 mg Grazoprevir - GT3, 800 mg Grazoprevir - GT1, 800 mg Grazoprevir - GT3 |
| PlaceboPlacebo tablet, orally, once a day for 7 days | Drug | 10 mg Grazoprevir - GT1, 100 mg Grazoprevir - GT1, 100 mg Grazoprevir - GT3, 200 mg Grazoprevir - GT1, 200 mg Grazoprevir - GT3, 30 mg Grazoprevir - GT1, 400 mg Grazoprevir - GT1, 400 mg Grazoprevir - GT3, 50 mg Grazoprevir - GT1, 50 mg Grazoprevir - GT3, 600 mg Grazoprevir - GT1, 600 mg Grazoprevir - GT3, 800 mg Grazoprevir - GT1, 800 mg Grazoprevir - GT3 |
Primary outcome
Number of Participants With Clinical and Laboratory Adverse Events (AEs)
Time frame: All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
4 secondary outcomes
Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7
Time frame: Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7
Time frame: Day 7 at 24 hours post-dose
Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo
Time frame: Baseline and up to approximately 2 months
Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo
Time frame: Baseline and up to approximately 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29703432Yeh WW, Fraser IP, Jumes P, Petry A, Lepeleire I, Robberechts M, Reitmann C, Van Dyck K, Huang X, Guo Z, Panebianco D, Nachbar RB, O'Mara E, Wagner JA, Butterton JR, Dutko FJ, Moiseev V, Kobalava Z, Huser A, Visan S, Schwabe C, Gane E, Popa S, Ghicavii N, Uhle M, Wagner F. Antiviral Activity, Safety, and Tolerability of Multiple Ascending Doses of Elbasvir or Grazoprevir in Participants Infected With Hepatitis C Virus Genotype-1 or -3. Clin Ther. 2018 May;40(5):704-718.e6. doi: 10.1016/j.clinthera.2018.03.002. Epub 2018 Apr 25.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.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 Grazoprevir 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 2 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 17 Jul 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 2 Mar 2016). 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?
Number of Participants With Clinical and Laboratory Adverse Events (AEs) (time frame: All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00998985, which also lists 1 linked publication.
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 17 Jul 2018.