Hepatitis CPhase 1NCT01335607
A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006)
A Phase 1 study testing Samatasvir tablet and Samatasvir capsule in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to: Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation) Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting. Read more about this study
- Who is it for?
- Ages 19 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Samatasvir tablet and Samatasvir capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to May 2011
- 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 19 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a healthy male with body mass index (BMI) between 18 and 35 kg/m
- Must agree to use an acceptable double-barrier method of birth control.
- Must provide written informed consent after the study has been fully explained.
Who cannot join
- History of clinically significant diseases, as determined by the investigator.
- Safety laboratory abnormalities at screening which are clinically significant.
- Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
- Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
- Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.
About this study
Official title: A Phase I, Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects
The purpose of this study is to:
- Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation)
- Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting.
- Determine the amount of study drug that is in the blood after eating a meal.
- Evaluate the safety of the tablet form of samatasvir in healthy people.
Read the detailed description
Each participant will receive each of the formulations in a crossover design. Part A Periods 1 and 2: Participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants will receive samatasvir tablets under fed conditons on Day 15.
Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive samatasvir capsules under fed conditons on Day 1.
- Conditions
- Hepatitis C
- Being tested
- Samatasvir tablet, Samatasvir capsule
- Keywords
- HCV, Hepatitis C Virus
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samatasvir tabletDrug
Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)
Samatasvir capsuleDrug
Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Samatasvir cap→tab→tab; Part B: cap | Active comparator | Part A: Samatasvir capsule as a single dose on Day 1 (fasting state) followed by samatasvir tablet as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) Receives: Drug: Samatasvir tablet; Drug: Samatasvir capsule |
| Part A: Samatasvir tab→cap→tab; Part B: cap | Active comparator | Part A: Samatasvir tablet as a single dose on Day 1 (fasting state) followed by samatasvir capsule as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) Receives: Drug: Samatasvir tablet; Drug: Samatasvir capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter: Observed maximum plasma drug concentration (Cmax)
Measured: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Time to maximum concentration (Tmax)
Measured: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to last measurable concentration (AUC 0-t)
Measured: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to 24 hours (AUC 0-24)
Measured: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to infinity (AUC 0-infinity)
Measured: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Plasma concentration at 24 hours post dose (C24h)
Measured: 24 hours
Pharmacokinetic parameter: Observed plasma terminal half-life (T1/2)
Measured: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Apparent oral total plasma clearance (CL/F)
Measured: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Apparent oral total plasma volume of distribution (Vz/F)
Measured: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Secondary outcomes (3)
Percentage of participants who experienced an adverse event
Measured: Up to Day 20
Percentage of participants who experienced a serious adverse event
Measured: Up to Day 20
Percentage of participants who experienced a Grade 1-4 laboratory abnormality
Measured: Up to Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT01335607
- Sponsor's protocol ID
- 2355-006
- Other IDs
- IDX-08C-006
- Status last verified
- Jan 2016
- First submitted
- 8 Apr 2011
- 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 Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01335607
- Acronym / sponsor ID
- 2355-006
- Conditions
- Hepatitis C
- Keywords
- HCV, Hepatitis C Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Apr 2011 (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:
- Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation)
- Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting.
- Determine the amount of study drug that is in the blood after eating a meal.
- Evaluate the safety of the tablet form of samatasvir in healthy people.
Detailed description
Each participant will receive each of the formulations in a crossover design. Part A Periods 1 and 2: Participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants will receive samatasvir tablets under fed conditons on Day 15.
Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive samatasvir capsules under fed conditons on Day 1.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Samatasvir cap→tab→tab; Part B: cap | Active comparator | Drug: Samatasvir tablet, Drug: Samatasvir capsulePart A: Samatasvir capsule as a single dose on Day 1 (fasting state) followed by samatasvir tablet as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) |
| Part A: Samatasvir tab→cap→tab; Part B: cap | Active comparator | Drug: Samatasvir tablet, Drug: Samatasvir capsulePart A: Samatasvir tablet as a single dose on Day 1 (fasting state) followed by samatasvir capsule as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be a healthy male with body mass index (BMI) between 18 and 35 kg/m
- Must agree to use an acceptable double-barrier method of birth control.
- Must provide written informed consent after the study has been fully explained.
Key exclusion criteria (5 listed)
- History of clinically significant diseases, as determined by the investigator.
- Safety laboratory abnormalities at screening which are clinically significant.
- Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
- Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
- Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.
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 |
|---|---|---|
| Samatasvir tabletTwo samatasvir (IDX184) 50 mg tablets (100 mg single oral dose) | Drug | Part A: Samatasvir cap→tab→tab; Part B: cap, Part A: Samatasvir tab→cap→tab; Part B: cap |
| Samatasvir capsuleTwo samatasvir (IDX184) 50 mg capsules (100 mg single oral dose) | Drug | Part A: Samatasvir cap→tab→tab; Part B: cap, Part A: Samatasvir tab→cap→tab; Part B: cap |
Primary outcome
Pharmacokinetic parameter: Observed maximum plasma drug concentration (Cmax)
Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Time to maximum concentration (Tmax)
Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to last measurable concentration (AUC 0-t)
Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to 24 hours (AUC 0-24)
Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to infinity (AUC 0-infinity)
Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Plasma concentration at 24 hours post dose (C24h)
Time frame: 24 hours
Pharmacokinetic parameter: Observed plasma terminal half-life (T1/2)
Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Apparent oral total plasma clearance (CL/F)
Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Pharmacokinetic parameter: Apparent oral total plasma volume of distribution (Vz/F)
Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
3 secondary outcomes
Percentage of participants who experienced an adverse event
Time frame: Up to Day 20
Percentage of participants who experienced a serious adverse event
Time frame: Up to Day 20
Percentage of participants who experienced a Grade 1-4 laboratory abnormality
Time frame: Up to Day 20
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 Samatasvir tablet and Samatasvir capsule in people with 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 3 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 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?
Pharmacokinetic parameter: Observed maximum plasma drug concentration (Cmax) (time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours). The study lists 9 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; AzTrials last refreshed its copy on 27 Oct 2026.