Hepatitis CPhase 1NCT00730431
Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)
A Phase 1 study testing IDX184 in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- IDX184
- 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
- Jul 2008to Oct 2008
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are in general good health.
- All participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control
Who cannot join
- Participant is pregnant or breastfeeding.
About this study
Official title: A Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IDX184 After Oral Administration in Healthy Subjects
The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.
- Conditions
- Hepatitis C
- Being tested
- IDX184, Placebo
- Keywords
- Hepatitis C, healthy volunteers
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDX184Drug
IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
PlaceboDrug
Placebo supplied as size 3, white opaque capsules matching IDX184 capsules.
| Study group | Role | What they receive |
|---|---|---|
| IDX184 5 mg | Experimental | Healthy participants will be administered a single 5 mg dose of IDX184. Receives: Drug: IDX184 |
| IDX184 10 mg | Experimental | Healthy participants will be administered a single 10 mg dose of IDX184. Receives: Drug: IDX184 |
| IDX184 25 mg | Experimental | Healthy participants will be administered a single 25 mg dose of IDX184. Receives: Drug: IDX184 |
| IDX184 50 mg | Experimental | Healthy participants will be administered a single 50 mg dose of IDX184. Receives: Drug: IDX184 |
| IDX184 75 mg | Experimental | Healthy participants will be administered a single 75 mg dose of IDX184. Receives: Drug: IDX184 |
| IDX184 100 mg | Experimental | Healthy participants will be administered a single 100 mg dose of IDX184. Receives: Drug: IDX184 |
| Placebo | Placebo comparator | Healthy participants will be administered placebo matching IDX184. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants experiencing serious adverse events (SAEs)
Measured: Up to Day 6
Percentage of participants experiencing AEs
Measured: Up to Day 6
Percentage of participants experiencing dose-limiting toxicity (DLTs)
Measured: Up to Day 6
Percentage of participants experiencing grade 1-4 laboratory abnormalities
Measured: Up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionOct 2008
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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
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
- NCT00730431
- Sponsor's protocol ID
- 2355-002
- Other IDs
- IDX-08C-002
- Status last verified
- Apr 2015
- First submitted
- 5 Aug 2008
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhou XJ, Pietropaolo K, Chen J, Khan S, Sullivan-Bolyai J, Mayers D. Safety and pharmacokinetics of IDX184, a liver-targeted nucleotide polymerase inhibitor of hepatitis C virus, in healthy subjects. Antimicrob Agents Chemother. 2011 Jan;55(1):76-81. doi: 10.1128/AAC.01101-10. Epub 2010 Nov 8.
PubMed 21060109
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IDX184 After Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00730431
- Acronym / sponsor ID
- 2355-002
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Aug 2008 (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 obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| IDX184 5 mg | Experimental | Drug: IDX184Healthy participants will be administered a single 5 mg dose of IDX184. |
| IDX184 10 mg | Experimental | Drug: IDX184Healthy participants will be administered a single 10 mg dose of IDX184. |
| IDX184 25 mg | Experimental | Drug: IDX184Healthy participants will be administered a single 25 mg dose of IDX184. |
| IDX184 50 mg | Experimental | Drug: IDX184Healthy participants will be administered a single 50 mg dose of IDX184. |
| IDX184 75 mg | Experimental | Drug: IDX184Healthy participants will be administered a single 75 mg dose of IDX184. |
| IDX184 100 mg | Experimental | Drug: IDX184Healthy participants will be administered a single 100 mg dose of IDX184. |
| Placebo | Placebo comparator | Drug: PlaceboHealthy participants will be administered placebo matching IDX184. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants are in general good health.
- All participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control
Key exclusion criteria (1 listed)
- Participant is pregnant or breastfeeding.
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 |
|---|---|---|
| IDX184IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg. | Drug | IDX184 10 mg, IDX184 100 mg, IDX184 25 mg, IDX184 5 mg, IDX184 50 mg, IDX184 75 mg |
| PlaceboPlacebo supplied as size 3, white opaque capsules matching IDX184 capsules. | Drug | Placebo |
Primary outcome
Percentage of participants experiencing serious adverse events (SAEs)
Time frame: Up to Day 6
Percentage of participants experiencing AEs
Time frame: Up to Day 6
Percentage of participants experiencing dose-limiting toxicity (DLTs)
Time frame: Up to Day 6
Percentage of participants experiencing grade 1-4 laboratory abnormalities
Time frame: Up to Day 6
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 23 Apr 2015.
- Results publication: PubMed 21060109Zhou XJ, Pietropaolo K, Chen J, Khan S, Sullivan-Bolyai J, Mayers D. Safety and pharmacokinetics of IDX184, a liver-targeted nucleotide polymerase inhibitor of hepatitis C virus, in healthy subjects. Antimicrob Agents Chemother. 2011 Jan;55(1):76-81. doi: 10.1128/AAC.01101-10. Epub 2010 Nov 8.
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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 IDX184 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 2 inclusion and 1 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 23 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. Some participants in this study may receive a placebo. 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?
Percentage of participants experiencing serious adverse events (SAEs) (time frame: Up to Day 6). 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?
On the ClinicalTrials.gov record for NCT00730431, 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 23 Apr 2015.