Hepatitis C, ChronicPhase 1NCT01554189
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)
A Phase 1 study testing MK-8325 in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts to this study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- MK-8325
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Apr 2013
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 18 to ≤37 kg/m^2
- Diagnosis of chronic HCV infection
- Must be infected with HCV GT1a, GT1b, or GT3
Who cannot join
- Co-infection with GT1 and GT3 HCV
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of neoplastic disease
- Positive Hepatitis B surface antigen
- History of human immunodeficiency virus (HIV) infection or positive HIV serology
Show all 14Show fewer
- Major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior
- History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months
- 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
- Previous treatments(s) with nonstructural 5A (NS5A) protein inhibitors
- Treatment with protease inhibitor(s) <30 days prior to study enrollment
- Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of MK-8325 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
About this study
Official title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C Infected Males
This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or may be staggered as needed by the clinical sites.
- Conditions
- Hepatitis C, Chronic
- Being tested
- MK-8325, 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.
MK-8325Drug
MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
PlaceboDrug
Placebo to match MK-8325 capsules, orally, once per day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Panel A (GT1 10 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Panel B (GT1 50 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Panel C (GT1 100 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Panel D (GT1 200 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Panel E (GT3 10 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Panel F (GT3 50 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Panel G (GT3 100 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Panel H (GT3 200 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Panel I (GT1a 10 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Panel J (GT1a 50 mg) | Experimental | Not described Receives: Drug: MK-8325 |
| Placebo Panel | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Day 5 in plasma HCV ribonucleic acid (RNA) in GT1 participants
Measured: Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose.
Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants
Measured: Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose.
Number of participants experiencing at least one adverse event
Measured: Day 1 up to 56 days
Number of participants discontinuing study drug due to an adverse event
Measured: Days 1-5
Secondary outcomes (3)
Trough plasma concentration (C24hr) of MK-8325
Measured: Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose
Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-8325
Measured: Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose
Maximum plasma concentration (Cmax) of MK-8325
Measured: Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- 37 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
- NCT01554189
- Sponsor's protocol ID
- 8325-002
- Other IDs
- 2011-006263-22
- Status last verified
- Jul 2015
- First submitted
- 12 Mar 2012
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 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-8325 in Hepatitis C Infected Males
- ClinicalTrials.gov ID
- NCT01554189
- Acronym / sponsor ID
- 8325-002
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 14 Mar 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 study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or may be staggered as needed by the clinical sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Panel A (GT1 10 mg) | Experimental | Drug: MK-8325 |
| Panel B (GT1 50 mg) | Experimental | Drug: MK-8325 |
| Panel C (GT1 100 mg) | Experimental | Drug: MK-8325 |
| Panel D (GT1 200 mg) | Experimental | Drug: MK-8325 |
| Panel E (GT3 10 mg) | Experimental | Drug: MK-8325 |
| Panel F (GT3 50 mg) | Experimental | Drug: MK-8325 |
| Panel G (GT3 100 mg) | Experimental | Drug: MK-8325 |
| Panel H (GT3 200 mg) | Experimental | Drug: MK-8325 |
| Panel I (GT1a 10 mg) | Experimental | Drug: MK-8325 |
| Panel J (GT1a 50 mg) | Experimental | Drug: MK-8325 |
| Placebo Panel | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) of 18 to ≤37 kg/m^2
- Diagnosis of chronic HCV infection
- Must be infected with HCV GT1a, GT1b, or GT3
Key exclusion criteria (14 listed)
- Co-infection with GT1 and GT3 HCV
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of neoplastic disease
- Positive Hepatitis B surface antigen
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-8325MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg) | Drug | Panel A (GT1 10 mg), Panel B (GT1 50 mg), Panel C (GT1 100 mg), Panel D (GT1 200 mg), Panel E (GT3 10 mg), Panel F (GT3 50 mg), Panel G (GT3 100 mg), Panel H (GT3 200 mg), Panel I (GT1a 10 mg), Panel J (GT1a 50 mg) |
| PlaceboPlacebo to match MK-8325 capsules, orally, once per day for 5 days | Drug | Placebo Panel |
Primary outcome
Change from baseline to Day 5 in plasma HCV ribonucleic acid (RNA) in GT1 participants
Time frame: Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose.
Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants
Time frame: Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose.
Number of participants experiencing at least one adverse event
Time frame: Day 1 up to 56 days
Number of participants discontinuing study drug due to an adverse event
Time frame: Days 1-5
3 secondary outcomes
Trough plasma concentration (C24hr) of MK-8325
Time frame: Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose
Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-8325
Time frame: Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose
Maximum plasma concentration (Cmax) of MK-8325
Time frame: Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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-8325 in people with Hepatitis C, Chronic, 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 3 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: stopped early, as of the sponsor's last update on 21 Jul 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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?
Change from baseline to Day 5 in plasma HCV ribonucleic acid (RNA) in GT1 participants (time frame: Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose.). The study lists 4 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 21 Jul 2015.