Hepatitis C, ChronicPhase 1NCT01919125
Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)
A Phase 1 study testing IDX719 in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 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?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Feb 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained.
- All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.
- Male subjects have agreed not to donate sperm from Day -1 through 90 days after the last dose of study drug.
Who cannot join
- Pregnant or breastfeeding.
- Other clinically significant medical conditions or laboratory abnormalities
About this study
Official title: A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.
- Conditions
- Hepatitis C, Chronic
- Being tested
- IDX719
- Keywords
- Chronic hepatitis C, Hepatitis C virus, HCV
- 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
Also called Samatasvir
IDX719 supplied as 50 mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Child-Pugh Class A | Experimental | Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1. Receives: Drug: IDX719 |
| Cohort 2: Child-Pugh Class B | Experimental | Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1. Receives: Drug: IDX719 |
| Cohort 3: Child-Pugh Class C | Experimental | Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1. Receives: Drug: IDX719 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: Up to 6 days
Time to maximum plasma concentration (Tmax)
Measured: Up to 6 days
Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last)
Measured: Up to 6 days
AUC from time zero to infinity (AUC0-~)
Measured: Up to 6 days
AUC from time zero to 24 hours (AUC0-24h)
Measured: Up to 6 days
Plasma concentration 24 hours after dosing (C24h)
Measured: Up to 6 days
Apparent terminal elimination rate constant
Measured: Up to 6 days
Observed terminal half-life (T1/2)
Measured: Up to 6 days
Secondary outcomes (3)
Percentage of participants experiencing serious adverse events (SAEs)
Measured: Up to 6 days
Percentage of participants experiencing an adverse event (AE)
Measured: Up to 6 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
Measured: Up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01919125
- Sponsor's protocol ID
- 1894-008
- Other IDs
- IDX-06A -008
- Status last verified
- Jan 2016
- First submitted
- 6 Aug 2013
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT01919125
- Acronym / sponsor ID
- 1894-008
- Conditions
- Hepatitis C, Chronic
- Keywords
- Chronic hepatitis C, Hepatitis C virus, HCV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Aug 2013 (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 this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Child-Pugh Class A | Experimental | Drug: IDX719Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
| Cohort 2: Child-Pugh Class B | Experimental | Drug: IDX719Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
| Cohort 3: Child-Pugh Class C | Experimental | Drug: IDX719Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained.
- All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.
- Male subjects have agreed not to donate sperm from Day -1 through 90 days after the last dose of study drug.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding.
- Other clinically significant medical conditions or laboratory abnormalities
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 |
|---|---|---|
| IDX719Also: SamatasvirIDX719 supplied as 50 mg tablets. | Drug | Cohort 1: Child-Pugh Class A, Cohort 2: Child-Pugh Class B, Cohort 3: Child-Pugh Class C |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: Up to 6 days
Time to maximum plasma concentration (Tmax)
Time frame: Up to 6 days
Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last)
Time frame: Up to 6 days
AUC from time zero to infinity (AUC0-~)
Time frame: Up to 6 days
AUC from time zero to 24 hours (AUC0-24h)
Time frame: Up to 6 days
Plasma concentration 24 hours after dosing (C24h)
Time frame: Up to 6 days
Apparent terminal elimination rate constant
Time frame: Up to 6 days
Observed terminal half-life (T1/2)
Time frame: Up to 6 days
3 secondary outcomes
Percentage of participants experiencing serious adverse events (SAEs)
Time frame: Up to 6 days
Percentage of participants experiencing an adverse event (AE)
Time frame: Up to 6 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
Time frame: Up to 6 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 26 Jan 2016.
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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 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 3 inclusion and 2 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 26 Jan 2016. 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?
Maximum plasma concentration (Cmax) (time frame: Up to 6 days). The study lists 8 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 26 Jan 2016.