Healthy VolunteersPhase 1NCT01043887
Ridaforolimus in Patients With Hepatic Insufficiency (MK-8669-046)
A Phase 1 study testing ridaforolimus in people with Healthy Volunteers and Hepatic Insufficiency, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the pharmacokinetics of ridaforolimus including the area under the concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Hepatic Insufficiency
- What is being tested?
- ridaforolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Apr 2010
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hepatic Patients:
- Female patient is of non-child bearing potential
- Apart from hepatic insufficiency with features of cirrhosis, patient is otherwise in good health
- Patient has a diagnosis of chronic stable hepatic insufficiency with features of cirrhosis
- Healthy Subjects:
- Female subject is of non-childbearing potential
- Subject is in good health
Who cannot join
- Hepatic Patients and Healthy Subjects:
- Works a night shift and is not able to avoid night shift work during the study
- Has a history of stroke, seizure or major neurological disease
- Has a history of cancer
- Is unable to refrain from or anticipates the use of any prescription or non-prescription drugs during the study
- Consumes excessive amounts of alcohol or caffeine
- Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
About this study
Official title: A Single Dose Study to Investigate the Pharmacokinetics of Ridaforolimus in Patients With Hepatic Insufficiency
This study will evaluate the pharmacokinetics of ridaforolimus including the area under the concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.
- Conditions
- Healthy Volunteers, Hepatic Insufficiency
- Being tested
- ridaforolimus
- Keywords
- Healthy Volunteers, Hepatic Insufficiency
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridaforolimusDrug
single oral dose administration 10 mg ridaforolimus
| Study group | Role | What they receive |
|---|---|---|
| Patients with Moderate Hepatic Insufficiency | Experimental | Patients with moderate hepatic insufficiency (a score of 7 to 9 on the Child-Pugh's scale) received a single 10 mg dose of ridaforolimus. Receives: Drug: ridaforolimus |
| Healthy Control Subjects | Experimental | Healthy control subjects were matched by race, age, gender, and body mass index (BMI) to the patients with moderate hepatic insufficiency. The healthy control subjects also received a single 10 mg dose of ridaforolimus. Receives: Drug: ridaforolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.
Measured: 288 hours postdose
Maximum Concentration (Cmax) of ridaforolimus following a single oral dose.
Measured: 288 hours postdose
Tmax of a Single Oral Dose of Ridaforolimus.
Measured: 288 hours postdose
Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.
Measured: 288 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043887
- Sponsor's protocol ID
- 8669-046
- Other IDs
- MK8669-046, 2009_706
- Status last verified
- Apr 2015
- First submitted
- 5 Jan 2010
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 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 Ridaforolimus in Patients With Hepatic Insufficiency
- ClinicalTrials.gov ID
- NCT01043887
- Acronym / sponsor ID
- 8669-046
- Conditions
- Healthy Volunteers, Hepatic Insufficiency
- Keywords
- Healthy Volunteers, Hepatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 7 Jan 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 pharmacokinetics of ridaforolimus including the area under the concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Moderate Hepatic Insufficiency | Experimental | Drug: ridaforolimusPatients with moderate hepatic insufficiency (a score of 7 to 9 on the Child-Pugh's scale) received a single 10 mg dose of ridaforolimus. |
| Healthy Control Subjects | Experimental | Drug: ridaforolimusHealthy control subjects were matched by race, age, gender, and body mass index (BMI) to the patients with moderate hepatic insufficiency. The healthy control subjects also received a single 10 mg dose of ridaforolimus. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patient is of non-child bearing potential
- Apart from hepatic insufficiency with features of cirrhosis, patient is otherwise in good health
- Patient has a diagnosis of chronic stable hepatic insufficiency with features of cirrhosis
- Female subject is of non-childbearing potential
- Subject is in good health
Key exclusion criteria (7 listed)
- Works a night shift and is not able to avoid night shift work during the study
- Has a history of stroke, seizure or major neurological disease
- Has a history of cancer
- Is unable to refrain from or anticipates the use of any prescription or non-prescription drugs during the study
- Consumes excessive amounts of alcohol or caffeine
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 |
|---|---|---|
| ridaforolimussingle oral dose administration 10 mg ridaforolimus | Drug | Healthy Control Subjects, Patients with Moderate Hepatic Insufficiency |
Primary outcome
Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.
Time frame: 288 hours postdose
Maximum Concentration (Cmax) of ridaforolimus following a single oral dose.
Time frame: 288 hours postdose
Tmax of a Single Oral Dose of Ridaforolimus.
Time frame: 288 hours postdose
Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.
Time frame: 288 hours postdose
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 29 Apr 2015.
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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 ridaforolimus in people with Healthy Volunteers and Hepatic Insufficiency, 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 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 29 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. 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-infinity]) of ridaforolimus following a single oral dose. (time frame: 288 hours postdose). 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 29 Apr 2015.