Hepatitis CPhase 1NCT01329913
Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)
A Phase 1 study testing MK-6325 in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive either MK-6325 or placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- MK-6325
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 18 to ≤37 kg/m^2.
- Stable health
- No clinically significant abnormality on electrocardiogram (ECG)
- Clinical diagnosis of chronic HCV infection (G1 or G3) for at least 6 months and detectable HCV RNA in peripheral blood.
Who cannot join
- Pregnancy or intention to become pregnant or father a child during the course of the study.
- History of stroke, chronic seizures, major neurological disorder, or uncontrolled clinically significant psychiatric disorder (for example, depression).
- Estimated creatinine clearance of ≤70 mL/min.
- History of clinically significant endocrine, gastrointestinal (except HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases whose current condition is considered clinically unstable.
- History of neoplastic disease other than adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix ≥10 years prior to the prestudy (screening) visit with no evidence of recurrence of likelihood of recurrence.
- Positive Hepatitis B surface antigen at the pre-study (screening) visit.
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- History of documented HIV infection or positive HIV serology at the pre-study (screening) visit.
- Regular consumption of excessive amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day.
- Excessive consumption, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) or coffee, tea, cola, or other caffeinated beverages per day.
- Major surgery, or donation or loss of 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
- History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
- Regular use of (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 months. Exception: marijuana use is permitted at the discretion of the investigator and provided the participant can refrain from its use during the study.
- Evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, autoimmune hepatitis. Note: Participants with history of acute non-HCV-related hepatitis, which resolved >6 months before study can be enrolled.
- Previous treatment with other HCV protease inhibitors ≤3 months prior to the first dose of study drug.
- Previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of MK-6325 in the study.
- Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy. Note: liver biopsy is not required for entry into the study.
About this study
Official title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-6325 in Hepatitis C Infected Male and Female Patients
This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive either MK-6325 or placebo. If the drug is shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected participants who will be randomized to receive either MK-6325 or placebo.
- Conditions
- Hepatitis C
- Being tested
- MK-6325, Placebo to MK-6325
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6325Drug
Two 100 mg capsules, orally, once per day for 7 days
Placebo to MK-6325Drug
Two 100 mg capsules, orally, once per day for 7 days
MK-6325Drug
Four 100 mg capsules, orally, once per day for 7 days
Placebo to MK-6325Drug
Four 100 mg capsules, orally, once per day for 7 days
MK-6325Drug
Eight 100 mg capsules, orally, once per day for 7 days
Placebo to MK-6325Drug
Eight 100 mg capsules, orally, once per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| GT1-HCV 200 mg | Experimental | Not described Receives: Drug: MK-6325; Drug: Placebo to MK-6325 |
| GT1-HCV 400 mg | Experimental | Not described Receives: Drug: MK-6325; Drug: Placebo to MK-6325 |
| GTI-HCV 800 mg | Experimental | Not described Receives: Drug: MK-6325; Drug: Placebo to MK-6325 |
| GT3-HCV 200 mg | Experimental | Not described Receives: Drug: MK-6325; Drug: Placebo to MK-6325 |
| GT3-HCV 400 mg | Experimental | Not described Receives: Drug: MK-6325; Drug: Placebo to MK-6325 |
| GT3-HCV 800 mg | Experimental | Not described Receives: Drug: MK-6325; Drug: Placebo to MK-6325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II)
Measured: Up to 15 days after last dose of study drug
Secondary outcomes (2)
Viral load reduction in GT1 HCV-infected participants (Part I)
Measured: 7 Days
Viral load reduction in GT3 HCV-infected participants (Part II)
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329913
- Sponsor's protocol ID
- 6325-003
- Other IDs
- 2010-023687-40
- Status last verified
- Feb 2015
- First submitted
- 4 Apr 2011
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-6325 in Hepatitis C Infected Male and Female Patients
- ClinicalTrials.gov ID
- NCT01329913
- Acronym / sponsor ID
- 6325-003
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Apr 2011 (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 is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive either MK-6325 or placebo. If the drug is shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected participants who will be randomized to receive either MK-6325 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GT1-HCV 200 mg | Experimental | Drug: MK-6325, Drug: Placebo to MK-6325 |
| GT1-HCV 400 mg | Experimental | Drug: MK-6325, Drug: Placebo to MK-6325 |
| GTI-HCV 800 mg | Experimental | Drug: MK-6325, Drug: Placebo to MK-6325 |
| GT3-HCV 200 mg | Experimental | Drug: MK-6325, Drug: Placebo to MK-6325 |
| GT3-HCV 400 mg | Experimental | Drug: MK-6325, Drug: Placebo to MK-6325 |
| GT3-HCV 800 mg | Experimental | Drug: MK-6325, Drug: Placebo to MK-6325 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) of 18 to ≤37 kg/m^2.
- Stable health
- No clinically significant abnormality on electrocardiogram (ECG)
- Clinical diagnosis of chronic HCV infection (G1 or G3) for at least 6 months and detectable HCV RNA in peripheral blood.
Key exclusion criteria (16 listed)
- Pregnancy or intention to become pregnant or father a child during the course of the study.
- History of stroke, chronic seizures, major neurological disorder, or uncontrolled clinically significant psychiatric disorder (for example, depression).
- Estimated creatinine clearance of ≤70 mL/min.
- History of clinically significant endocrine, gastrointestinal (except HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases whose current condition is considered clinically unstable.
- History of neoplastic disease other than adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix ≥10 years prior to the prestudy (screening) visit with no evidence of recurrence of likelihood of recurrence.
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 |
|---|---|---|
| MK-6325Two 100 mg capsules, orally, once per day for 7 days | Drug | GT1-HCV 200 mg, GT3-HCV 200 mg |
| Placebo to MK-6325Two 100 mg capsules, orally, once per day for 7 days | Drug | GT1-HCV 200 mg, GT3-HCV 200 mg |
| MK-6325Four 100 mg capsules, orally, once per day for 7 days | Drug | GT1-HCV 400 mg, GT3-HCV 400 mg |
| Placebo to MK-6325Four 100 mg capsules, orally, once per day for 7 days | Drug | GT1-HCV 400 mg, GT3-HCV 400 mg |
| MK-6325Eight 100 mg capsules, orally, once per day for 7 days | Drug | GT3-HCV 800 mg, GTI-HCV 800 mg |
| Placebo to MK-6325Eight 100 mg capsules, orally, once per day for 7 days | Drug | GT3-HCV 800 mg, GTI-HCV 800 mg |
Primary outcome
Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II)
Time frame: Up to 15 days after last dose of study drug
2 secondary outcomes
Viral load reduction in GT1 HCV-infected participants (Part I)
Time frame: 7 Days
Viral load reduction in GT3 HCV-infected participants (Part II)
Time frame: 7 Days
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 5 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-6325 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 4 inclusion and 16 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 5 Feb 2015. 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?
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?
Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II) (time frame: Up to 15 days after last dose of study drug). 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 5 Feb 2015.