Healthy VolunteerPhase 1NCT01711775
A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers
A Phase 1 study testing aleglitazar in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in China.
Trial summary
This single-center, non-randomized, open-label study will assess the pharmacokinetics of aleglitazar after administration of single and multiple oral doses in healthy Chinese volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated oral doses once daily from Day 5 to Day 14. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- aleglitazar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Dec 2012
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female and male Chinese volunteers, 18 to 45 years of age inclusive at screening
- Subjects have to be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory measurements performed at screening
- Body mass index (BMI) 19 to 24 kg/m2 inclusive
- Female subjects who are not surgically sterile must be willing to use effective method of contraception as defined by protocol throughout the study and for 30 days after the last dosing
Who cannot join
- Any significant allergic reactions or multiple allergies
- Diagnosed or treated malignancy (except for treated cases of basal skin cancer or in situ carcinoma of the cervix) within the past 5 years
- Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
- Positive for hepatitis B, hepatitis C or HIV infection
- Any clinically relevant history of alcohol and/or other substance abuse or addiction within the last 2 years
- Pregnant or lactating women, or women who have a positive pregnancy test
- Regular smoker with consumption of more than 10 cigarettes per day or equivalent amount of tobacco
- Participation in an investigational drug or device study within 3 months prior to the first dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Non-randomized, Open-label Study to Assess the Pharmacokinetics of Aleglitazar (RO0728804) After Administration of Single and Multiple Oral Doses of 150 µg Tablet in Healthy Chinese Subjects
This single-center, non-randomized, open-label study will assess the pharmacokinetics of aleglitazar after administration of single and multiple oral doses in healthy Chinese volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening and a 2-week follow-up, is up to 8 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- aleglitazar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aleglitazarDrug
Single oral dose Day 1, repeated oral dose once daily Days 5-14
| Study group | Role | What they receive |
|---|---|---|
| Aleglitazar | Experimental | Not described Receives: Drug: aleglitazar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax)
Measured: Day 14 pre-dose and up to 24 hours post-dose
Pharmacokinetics: Day 14 (steady-state) area under the concentration-time curve (AUC 0-24)
Measured: Day 14 pre-dose and up to 24 hours post-dose
Secondary outcomes (8)
Pharmacokinetics: Maximum concentration (Cmax)
Measured: 18 days
Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)
Measured: up to 5 days
Single-dose pharmacokinetics: Half-life (t1/2)
Measured: up to 5 days
Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)
Measured: up to 5 days
Pharmacokinetics: Apparent oral plasma clearance (CL/F)
Measured: 18 days
Pharmacokinetics: Apparent volume of distribution (VZ/F)
Measured: 18 days
Pharmacokinetics: Accumulation index (Rac)
Measured: 18 days
Safety: Incidence of adverse events
Measured: approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT01711775
- Sponsor's protocol ID
- BP25230
- Status last verified
- Nov 2016
- First submitted
- 18 Oct 2012
- 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
- A Single-center, Non-randomized, Open-label Study to Assess the Pharmacokinetics of Aleglitazar (RO0728804) After Administration of Single and Multiple Oral Doses of 150 µg Tablet in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT01711775
- Acronym / sponsor ID
- BP25230
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Oct 2012 (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 single-center, non-randomized, open-label study will assess the pharmacokinetics of aleglitazar after administration of single and multiple oral doses in healthy Chinese volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening and a 2-week follow-up, is up to 8 weeks.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aleglitazar | Experimental | Drug: aleglitazar |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female and male Chinese volunteers, 18 to 45 years of age inclusive at screening
- Subjects have to be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory measurements performed at screening
- Body mass index (BMI) 19 to 24 kg/m2 inclusive
- Female subjects who are not surgically sterile must be willing to use effective method of contraception as defined by protocol throughout the study and for 30 days after the last dosing
Key exclusion criteria (8 listed)
- Any significant allergic reactions or multiple allergies
- Diagnosed or treated malignancy (except for treated cases of basal skin cancer or in situ carcinoma of the cervix) within the past 5 years
- Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
- Positive for hepatitis B, hepatitis C or HIV infection
- Any clinically relevant history of alcohol and/or other substance abuse or addiction within the last 2 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 |
|---|---|---|
| aleglitazarSingle oral dose Day 1, repeated oral dose once daily Days 5-14 | Drug | Aleglitazar |
Primary outcome
Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax)
Time frame: Day 14 pre-dose and up to 24 hours post-dose
Pharmacokinetics: Day 14 (steady-state) area under the concentration-time curve (AUC 0-24)
Time frame: Day 14 pre-dose and up to 24 hours post-dose
8 secondary outcomes
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: 18 days
Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)
Time frame: up to 5 days
Single-dose pharmacokinetics: Half-life (t1/2)
Time frame: up to 5 days
Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: up to 5 days
Pharmacokinetics: Apparent oral plasma clearance (CL/F)
Time frame: 18 days
Pharmacokinetics: Apparent volume of distribution (VZ/F)
Time frame: 18 days
Pharmacokinetics: Accumulation index (Rac)
Time frame: 18 days
Safety: Incidence of adverse events
Time frame: approximately 10 months
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 recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aleglitazar in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in China.
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 4 inclusion and 8 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 1 site in China. 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?
Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax) (time frame: Day 14 pre-dose and up to 24 hours post-dose). The study lists 2 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 2 Nov 2016.