Hepatitis C, ChronicPhase 1/2NCT01508156
Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)
A Phase 1/2 study testing IDX719 in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- IDX719
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jul 2012
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants
- Is in good general health.
- Agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs.
- HCV Participants
- Has documented GT1, GT2, or GT3 chronic HCV infection.
Who cannot join
- All Participants
- Is pregnant or breastfeeding.
- HCV Participants
- Has received prior HCV treatment.
- Is co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
About this study
Official title: A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects
The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.
- Conditions
- Hepatitis C, Chronic
- Being tested
- IDX719, Placebo
- Keywords
- Hepatitis C, HCV, treatment-naive
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDX719Drug
IDX719 liquid suspension (1 - 100 mg) taken by mouth.
PlaceboDrug
Placebo liquid suspension matching IDX719 taken by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Healthy Participants | Experimental | Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses. Receives: Drug: IDX719; Drug: Placebo |
| Group B: HCV Participants | Experimental | Treatment-naive participants infected with HCV genotype (GT) 1, GT2, or GT3 take IDX719 (1 mg - 100 mg) or matching placebo as either 1 single dose or as 7 daily doses. Receives: Drug: IDX719; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants experiencing an adverse event (AE)
Measured: Up to 14 days
Percentage of participants experiencing serious AEs (SAEs)
Measured: Up to 14 days
Change in HCV ribonucleic acid (RNA)
Measured: Baseline and Day 10
Maximum plasma drug concentration (Cmax)
Measured: Pre-dose Day 1 to Day 13
Time to maximum plasma drug concentration (Tmax)
Measured: Pre-dose Day 1 to Day 13
Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t)
Measured: Pre-dose Day 1 to Day 13
AUC from time zero to time 24 hours (AUC0-24h)
Measured: Pre-dose Day 1 to Day 1
AUC from time zero to time infinity (AUC0-~)
Measured: Pre-dose Day 1 to Day 13
Pre-dose trough plasma drug concentration (Ctrough)
Measured: Pre-dose Day 1
Observed terminal plasma drug concentration half-life (t1/2)
Measured: Pre-dose Day 1 to Day 13
Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses)
Measured: Pre-dose Day 1 to Day 13
Apparent oral total volume of distribution (Vz/F)
Measured: Pre-dose Day 1 to Day 13
Amount excreted in urine in each collection interval (Au)
Measured: Pre-dose Day 1 to Day 14
Cumulative urine excretion (Au0-t)
Measured: Pre-dose Day 1 to Day 14
Percentage of dose excreted in urine (% Dose excr)
Measured: Pre-dose Day 1 to Day 14
Renal clearance (CLr)
Measured: Pre-dose Day 1 to Day 14
Percentage of participants experiencing dose-limiting toxicity
Measured: Up to 8 days
Percentage of participants experiencing graded laboratory abnormalities
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 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
- NCT01508156
- Sponsor's protocol ID
- 1894-001
- Other IDs
- IDX-06A-001
- Status last verified
- Apr 2015
- First submitted
- 9 Jan 2012
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vince B, Hill JM, Lawitz EJ, O'Riordan W, Webster LR, Gruener DM, Mofsen RS, Murillo A, Donovan E, Chen J, McCarville JF, Sullivan-Bolyai JZ, Mayers D, Zhou XJ. A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus genotype 1, 2, 3 or 4. J Hepatol. 2014 May;60(5):920-7. doi: 10.1016/j.jhep.2014.01.003. Epub 2014 Jan 14.
PubMed 24434503
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects
- ClinicalTrials.gov ID
- NCT01508156
- Acronym / sponsor ID
- 1894-001
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, HCV, treatment-naive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Jan 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.
The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Healthy Participants | Experimental | Drug: IDX719, Drug: PlaceboHealthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses. |
| Group B: HCV Participants | Experimental | Drug: IDX719, Drug: PlaceboTreatment-naive participants infected with HCV genotype (GT) 1, GT2, or GT3 take IDX719 (1 mg - 100 mg) or matching placebo as either 1 single dose or as 7 daily doses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All Participants
- Is in good general health.
- Agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs.
- HCV Participants
- Has documented GT1, GT2, or GT3 chronic HCV infection.
Key exclusion criteria (5 listed)
- All Participants
- Is pregnant or breastfeeding.
- HCV Participants
- Has received prior HCV treatment.
- Is co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
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 |
|---|---|---|
| IDX719IDX719 liquid suspension (1 - 100 mg) taken by mouth. | Drug | Group A: Healthy Participants, Group B: HCV Participants |
| PlaceboPlacebo liquid suspension matching IDX719 taken by mouth. | Drug | Group A: Healthy Participants, Group B: HCV Participants |
Primary outcome
Percentage of participants experiencing an adverse event (AE)
Time frame: Up to 14 days
Percentage of participants experiencing serious AEs (SAEs)
Time frame: Up to 14 days
Change in HCV ribonucleic acid (RNA)
Time frame: Baseline and Day 10
Maximum plasma drug concentration (Cmax)
Time frame: Pre-dose Day 1 to Day 13
Time to maximum plasma drug concentration (Tmax)
Time frame: Pre-dose Day 1 to Day 13
Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t)
Time frame: Pre-dose Day 1 to Day 13
AUC from time zero to time 24 hours (AUC0-24h)
Time frame: Pre-dose Day 1 to Day 1
AUC from time zero to time infinity (AUC0-~)
Time frame: Pre-dose Day 1 to Day 13
Pre-dose trough plasma drug concentration (Ctrough)
Time frame: Pre-dose Day 1
Observed terminal plasma drug concentration half-life (t1/2)
Time frame: Pre-dose Day 1 to Day 13
Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses)
Time frame: Pre-dose Day 1 to Day 13
Apparent oral total volume of distribution (Vz/F)
Time frame: Pre-dose Day 1 to Day 13
Amount excreted in urine in each collection interval (Au)
Time frame: Pre-dose Day 1 to Day 14
Cumulative urine excretion (Au0-t)
Time frame: Pre-dose Day 1 to Day 14
Percentage of dose excreted in urine (% Dose excr)
Time frame: Pre-dose Day 1 to Day 14
Renal clearance (CLr)
Time frame: Pre-dose Day 1 to Day 14
Percentage of participants experiencing dose-limiting toxicity
Time frame: Up to 8 days
Percentage of participants experiencing graded laboratory abnormalities
Time frame: Up to 14 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 27 Apr 2015.
- Results publication: PubMed 24434503Vince B, Hill JM, Lawitz EJ, O'Riordan W, Webster LR, Gruener DM, Mofsen RS, Murillo A, Donovan E, Chen J, McCarville JF, Sullivan-Bolyai JZ, Mayers D, Zhou XJ. A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus genotype 1, 2, 3 or 4. J Hepatol. 2014 May;60(5):920-7. doi: 10.1016/j.jhep.2014.01.003. Epub 2014 Jan 14.
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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 1/2 study testing IDX719 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 5 inclusion and 5 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 27 Apr 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of participants experiencing an adverse event (AE) (time frame: Up to 14 days). The study lists 18 primary outcomes in all. 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 NCT01508156, 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 27 Apr 2015.