Chronic Hepatitis CPhase 1NCT02112942
Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
A Phase 1 study testing IDX21459 in people with Chronic Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- IDX21459
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects
- Subjects are in good general health.
- Subjects have provided written informed consent form.
- 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. HCV Subjects
- Documented clinical history compatible with chronic hepatitis C without cirrhosis.
- Treatment-naïve
- HCV Genotype 1
Who cannot join
- All subjects
- Pregnant or breastfeeding
- Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
- Decompensated liver disease
- Other clinically significant medical conditions or laboratory abnormalities.
About this study
Official title: A Phase I Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.
- Conditions
- Chronic Hepatitis C
- Being tested
- IDX21459, Matching Placebo
- Keywords
- 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.
IDX21459Drug
Matching PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days Receives: Drug: IDX21459; Drug: Matching Placebo |
| Group B | Experimental | HCV subjects genotype 1, IDX21459 capsules, once for 1 day Receives: Drug: IDX21459 |
| Group C | Experimental | HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days Receives: Drug: IDX21459; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessment
Proportion of subjects experiencing adverse events.
Measured: up to 35 days
Secondary outcomes (1)
Pharmacokinetic
Plasma and urine concentrations of IDX21459 and its metabolite/s.
Measured: Up to 120 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 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Early termination of IDX21459 was due to integration of Merck's HCV antiviral pipeline has resulted in revisions of the clinical development plan.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT02112942
- Sponsor's protocol ID
- 7822-001
- Other IDs
- IDX-04C-001
- Status last verified
- Jan 2016
- First submitted
- 10 Apr 2014
- 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 Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
- ClinicalTrials.gov ID
- NCT02112942
- Acronym / sponsor ID
- 7822-001
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C virus, HCV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination of IDX21459 was due to integration of Merck's HCV antiviral pipeline has resulted in revisions of the clinical development plan.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Apr 2014 (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.
A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: IDX21459, Drug: Matching PlaceboHealthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days |
| Group B | Experimental | Drug: IDX21459HCV subjects genotype 1, IDX21459 capsules, once for 1 day |
| Group C | Experimental | Drug: IDX21459, Drug: Matching PlaceboHCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All subjects
- Subjects are in good general health.
- Subjects have provided written informed consent form.
- 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. HCV Subjects
- Documented clinical history compatible with chronic hepatitis C without cirrhosis.
Key exclusion criteria (5 listed)
- All subjects
- Pregnant or breastfeeding
- Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
- Decompensated liver disease
- 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 |
|---|---|---|
| IDX21459 | Drug | Group A, Group B, Group C |
| Matching Placebo | Drug | Group A, Group C |
Primary outcome
Safety and tolerability assessment
Time frame: up to 35 days
Proportion of subjects experiencing adverse events.
1 secondary outcome
Pharmacokinetic
Time frame: Up to 120 hours post dose
Results and safety
The study was stopped early (reason given: Early termination of IDX21459 was due to integration of Merck's HCV antiviral pipeline has resulted in revisions of the clinical development plan.). Results are not available in the source record.
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.
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 IDX21459 in people with Chronic 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 7 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: stopped early, 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 was stopped early (reason given: Early termination of IDX21459 was due to integration of Merck's HCV antiviral pipeline has resulted in revisions of the clinical development plan.). 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?
Safety and tolerability assessment (time frame: up to 35 days). 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.