Chronic Hepatitis C InfectionPhase 1NCT01813513
Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)
A Phase 1 study testing IDX719 and Simeprevir in people with Chronic Hepatitis C Infection, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. 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 Infection
- What is being tested?
- IDX719 and Simeprevir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jul 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
- Agrees 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 study drug
- Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study
Who cannot join
- Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
- Is pregnant or breastfeeding
- Has previously received either IDX719 or simeprevir
- Has participated in another clinical drug study within 30 days of Screening
About this study
Official title: A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Subjects
The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- IDX719, Simeprevir
- Keywords
- HCV, Hepatitis C Virus, Hepatitis C, antiviral drugs, liver
- Medical subject headings
- 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
50 mg tablet for oral administration
SimeprevirDrug
Also called Olysio™
150 mg capsule for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Group A: IDX719 then IDX719/Simeprevir | Experimental | Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. Receives: Drug: IDX719; Drug: Simeprevir |
| Group B: Simeprevir then IDX719/Simeprevir | Experimental | Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. Receives: Drug: IDX719; Drug: Simeprevir |
| Group C: IDX719 | Experimental | Healthy participants take IDX719 150 mg QD on Days 1-14. Receives: Drug: IDX719 |
| Group D: IDX719/Simeprevir | Experimental | Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK. Receives: Drug: IDX719; Drug: Simeprevir |
| Group E: High-Fat then Low-Fat PK | Experimental | Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout). Receives: Drug: IDX719 |
| Group F: Low-Fat then High-Fat PK | Experimental | Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout). Receives: Drug: IDX719 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)
Measured: Up to 30 days
Maximum observed plasma concentration (Cmax)
Measured: Up to 30 days
AUC from time zero to infinity
Measured: Up to 30 days
Trough plasma concentration (Ctrough)
Measured: Up to 30 days
Secondary outcomes (3)
Percentage of participants experiencing serious adverse events (SAEs)
Measured: Up to 30 days
Percentage of participants experiencing adverse events (AEs)
Measured: Up to 30 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C InfectionStudies 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
- None (open label)
- Enrolment
- 42 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
- NCT01813513
- Sponsor's protocol ID
- 1894-004
- Other IDs
- IDX-06A-004
- Status last verified
- Jan 2016
- First submitted
- 13 Mar 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, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01813513
- Acronym / sponsor ID
- 1894-004
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- HCV, Hepatitis C Virus, Hepatitis C, antiviral drugs, liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Mar 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 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A: IDX719 then IDX719/Simeprevir | Experimental | Drug: IDX719, Drug: SimeprevirHealthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. |
| Group B: Simeprevir then IDX719/Simeprevir | Experimental | Drug: IDX719, Drug: SimeprevirHealthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. |
| Group C: IDX719 | Experimental | Drug: IDX719Healthy participants take IDX719 150 mg QD on Days 1-14. |
| Group D: IDX719/Simeprevir | Experimental | Drug: IDX719, Drug: SimeprevirParticipants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK. |
| Group E: High-Fat then Low-Fat PK | Experimental | Drug: IDX719Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout). |
| Group F: Low-Fat then High-Fat PK | Experimental | Drug: IDX719Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
- Agrees 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 study drug
- Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study
Key exclusion criteria (4 listed)
- Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
- Is pregnant or breastfeeding
- Has previously received either IDX719 or simeprevir
- Has participated in another clinical drug study within 30 days of Screening
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: Samatasvir50 mg tablet for oral administration | Drug | Group A: IDX719 then IDX719/Simeprevir, Group B: Simeprevir then IDX719/Simeprevir, Group C: IDX719, Group D: IDX719/Simeprevir, Group E: High-Fat then Low-Fat PK, Group F: Low-Fat then High-Fat PK |
| SimeprevirAlso: Olysio™150 mg capsule for oral administration | Drug | Group A: IDX719 then IDX719/Simeprevir, Group B: Simeprevir then IDX719/Simeprevir, Group D: IDX719/Simeprevir |
Primary outcome
Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)
Time frame: Up to 30 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 30 days
AUC from time zero to infinity
Time frame: Up to 30 days
Trough plasma concentration (Ctrough)
Time frame: Up to 30 days
3 secondary outcomes
Percentage of participants experiencing serious adverse events (SAEs)
Time frame: Up to 30 days
Percentage of participants experiencing adverse events (AEs)
Time frame: Up to 30 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
Time frame: Up to 30 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.
Related trials for Chronic Hepatitis C Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
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 and Simeprevir in people with Chronic Hepatitis C Infection, 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 4 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?
Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss) (time frame: Up to 30 days). 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 26 Jan 2016.