Healthy VolunteerPhase 1NCT01099904
A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
A Phase 1 study testing RO5024048 in people with Healthy Volunteer, run by Hoffmann-La Roche at 3 sites in 2 countries.
Trial summary
This open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and assess the effect of renal impairment on safety and tolerability of RO5024048. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO5024048
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2010to Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female adults, 18-75 years of age
- normal, or mildly or moderately impaired renal function (creatinine clearance >/= 30 mL/min)
- BMI 18-40 kg/m2
- stable renal function
- agree to abstain from alcohol consumption during study drug adminsitration and limit consumption up to the end of the study
- agree to abstain from coffein consumption throughout study
Who cannot join
- positive urine or blood test for drugs of abuse not under a physician's prescription
- positive for HIV or HCV, or HBV with clinical symptoms or history of hepatitis
- uncontrolled hypertension
- renal transplant, dialysis patient, nephritic syndrome
- clinically significant cardiovascular, central nervous system, gastrointestinal or liver disease or disorder
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Study site
Knoxville, Tennessee, 37920
Study site
Orlando, Florida, 32809
About this study
Official title: The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
This open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or females with either normal renal function or mild or moderate renal impairment will receive RO5024048 orally for 5 days. Target sample size is <50.
- Conditions
- Healthy Volunteer
- Being tested
- RO5024048
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5024048Drug
multiple oral doses for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Normal Renal Function Receives: Drug: RO5024048 |
| 2 | Experimental | Mild Renal Impairment Receives: Drug: RO5024048 |
| 3 | Experimental | Moderate Renal Impairment Receives: Drug: RO5024048 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl
Measured: sampling days 1 and 3-11
Secondary outcomes (1)
Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters
Measured: Throughout study, ECG and laboratory assessments days 3, 5, 6 and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099904
- Sponsor's protocol ID
- PP21536
- Status last verified
- Nov 2016
- First submitted
- 6 Apr 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
- ClinicalTrials.gov ID
- NCT01099904
- Acronym / sponsor ID
- PP21536
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Apr 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 open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or females with either normal renal function or mild or moderate renal impairment will receive RO5024048 orally for 5 days. Target sample size is <50.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RO5024048Normal Renal Function |
| 2 | Experimental | Drug: RO5024048Mild Renal Impairment |
| 3 | Experimental | Drug: RO5024048Moderate Renal Impairment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female adults, 18-75 years of age
- normal, or mildly or moderately impaired renal function (creatinine clearance >/= 30 mL/min)
- BMI 18-40 kg/m2
- stable renal function
- agree to abstain from alcohol consumption during study drug adminsitration and limit consumption up to the end of the study
Key exclusion criteria (5 listed)
- positive urine or blood test for drugs of abuse not under a physician's prescription
- positive for HIV or HCV, or HBV with clinical symptoms or history of hepatitis
- uncontrolled hypertension
- renal transplant, dialysis patient, nephritic syndrome
- clinically significant cardiovascular, central nervous system, gastrointestinal or liver disease or disorder
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 |
|---|---|---|
| RO5024048multiple oral doses for 5 days | Drug | 1, 2, 3 |
Primary outcome
Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl
Time frame: sampling days 1 and 3-11
1 secondary outcome
Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters
Time frame: Throughout study, ECG and laboratory assessments days 3, 5, 6 and 17
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 2 Nov 2016.
Related trials for Healthy Volunteer
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
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.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5024048 in people with Healthy Volunteer, run by Hoffmann-La Roche at 3 sites in 2 countries.
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 6 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl (time frame: sampling days 1 and 3-11). 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 2 Nov 2016.