DyslipidemiaPhase 1NCT01122667
Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)
A Phase 1 study testing anacetrapib in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- anacetrapib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study
- Subject is in good health
- If Subject is a smoker, smoking is limited to no more than 10 cigarettes per day
Who cannot join
- Subject has a history of stroke, chronic seizures or major neurological disorder
- Subject has a history of cancer
- Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
- Subject consumes excessive amounts of alcohol or caffeine
- Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
- Subject is a nursing mother
- Subject has had a kidney removed or has a functioning renal transplant
About this study
Official title: A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function
This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.
- Conditions
- Dyslipidemia
- Being tested
- anacetrapib
- Keywords
- Renal Insufficiency
- Medical subject headings
- Dyslipidemias, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anacetrapibDrug
single dose administration of anacetrapib (MK0859) 100 mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Panel A | Experimental | Subjects with severe renal impairment Receives: Drug: anacetrapib |
| Part 1 - Panel B | Experimental | Healthy matched control subjects Receives: Drug: anacetrapib |
| Part 2 - Panel C | Experimental | Subjects with moderate renal impairment Receives: Drug: anacetrapib |
| Part 2 - Panel D | Experimental | Healthy matched control subjects Receives: Drug: anacetrapib |
| Part 2 - Panel E | Experimental | Subjects with mild renal impairment Receives: Drug: anacetrapib |
| Part 2 - Panel F | Experimental | Healthy matched control subjects Receives: Drug: anacetrapib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC(0 to infinity)) of anacetrapib
Measured: through 168 hours post dose
Secondary outcomes (1)
Safety and tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events
Measured: through 14 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
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 DyslipidemiaStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122667
- Sponsor's protocol ID
- 0859-038
- Other IDs
- MK0859-038
- Status last verified
- Aug 2015
- First submitted
- 11 May 2010
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lauring B, Li XS, Liu Y, Corr C, Lazarus N, Cote J, Larson P, Levonas AO, Lasseter KC, Preston RA, Smith WB, Lai E, Wagner JA. Influence of renal and hepatic impairment on the pharmacokinetics of anacetrapib. J Clin Pharmacol. 2014 Nov;54(11):1247-55. doi: 10.1002/jcph.320. Epub 2014 Jun 6.
PubMed 24782116
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT01122667
- Acronym / sponsor ID
- 0859-038
- Conditions
- Dyslipidemia
- Keywords
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 May 2010 (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.
This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Panel A | Experimental | Drug: anacetrapibSubjects with severe renal impairment |
| Part 1 - Panel B | Experimental | Drug: anacetrapibHealthy matched control subjects |
| Part 2 - Panel C | Experimental | Drug: anacetrapibSubjects with moderate renal impairment |
| Part 2 - Panel D | Experimental | Drug: anacetrapibHealthy matched control subjects |
| Part 2 - Panel E | Experimental | Drug: anacetrapibSubjects with mild renal impairment |
| Part 2 - Panel F | Experimental | Drug: anacetrapibHealthy matched control subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study
- Subject is in good health
- If Subject is a smoker, smoking is limited to no more than 10 cigarettes per day
Key exclusion criteria (7 listed)
- Subject has a history of stroke, chronic seizures or major neurological disorder
- Subject has a history of cancer
- Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
- Subject consumes excessive amounts of alcohol or caffeine
- Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
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 |
|---|---|---|
| anacetrapibsingle dose administration of anacetrapib (MK0859) 100 mg oral tablet | Drug | Part 1 - Panel A, Part 1 - Panel B, Part 2 - Panel C, Part 2 - Panel D, Part 2 - Panel E, Part 2 - Panel F |
Primary outcome
Area Under the Curve (AUC(0 to infinity)) of anacetrapib
Time frame: through 168 hours post dose
1 secondary outcome
Safety and tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events
Time frame: through 14 days post dose
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 14 Aug 2015.
- Results publication: PubMed 24782116Lauring B, Li XS, Liu Y, Corr C, Lazarus N, Cote J, Larson P, Levonas AO, Lasseter KC, Preston RA, Smith WB, Lai E, Wagner JA. Influence of renal and hepatic impairment on the pharmacokinetics of anacetrapib. J Clin Pharmacol. 2014 Nov;54(11):1247-55. doi: 10.1002/jcph.320. Epub 2014 Jun 6.
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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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anacetrapib in people with Dyslipidemia, 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 7 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 14 Aug 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. 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 Curve (AUC(0 to infinity)) of anacetrapib (time frame: through 168 hours post dose). 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 NCT01122667, 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 14 Aug 2015.