Healthy VolunteerPhase 1NCT01679639
A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers
A Phase 1 study testing aleglitazar and rifampicin in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial summary
This open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- aleglitazar and rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, aged 18 to 55 years inclusive at the time of screening
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
- Females must be surgically sterile or use two acceptable methods of contraception
- Non-smoker or currently smoking less than five cigarettes/day and willing to abstain from smoking during the study
Who cannot join
- Any clinically relevant abnormal laboratory test results at screening or on Day -1 of all periods, as judged by the Investigator
- A history of clinically significant disorders (e.g., gastro-intestinal, cardiovascular, hepatic)
- Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- An average alcohol intake of more than 14 units per week
- Volunteers diagnosed, or suspected of having porphyria, and subjects with first degree relatives diagnosed, or suspected of having porphyria
- Diagnosis of Gilberts Syndrome
- A positive screen for drugs of abuse at screening or on admission to the clinical unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar in Healthy Subjects
This open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is up to 14 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- aleglitazar, rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aleglitazarDrug
Single dose of aleglitazar in Periods 1, 2, 3
rifampicinDrug
Single dose in Periods 1 and 2; multiple doses in Period 3
| Study group | Role | What they receive |
|---|---|---|
| Aleglitazar | Experimental | Not described Receives: Drug: aleglitazar; Drug: rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under the plasma concentration time curve
Measured: Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12
Secondary outcomes (1)
Safety: incidence of adverse events
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startAug 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
- 24 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
- NCT01679639
- Sponsor's protocol ID
- BP25561
- Other IDs
- 2012-002274-31
- Status last verified
- Nov 2016
- First submitted
- 1 Sep 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
- An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01679639
- Acronym / sponsor ID
- BP25561
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Sep 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 open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is up to 14 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, Drug: rifampicin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers, aged 18 to 55 years inclusive at the time of screening
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
- Females must be surgically sterile or use two acceptable methods of contraception
- Non-smoker or currently smoking less than five cigarettes/day and willing to abstain from smoking during the study
Key exclusion criteria (7 listed)
- Any clinically relevant abnormal laboratory test results at screening or on Day -1 of all periods, as judged by the Investigator
- A history of clinically significant disorders (e.g., gastro-intestinal, cardiovascular, hepatic)
- Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- An average alcohol intake of more than 14 units per week
- Volunteers diagnosed, or suspected of having porphyria, and subjects with first degree relatives diagnosed, or suspected of having porphyria
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 dose of aleglitazar in Periods 1, 2, 3 | Drug | Aleglitazar |
| rifampicinSingle dose in Periods 1 and 2; multiple doses in Period 3 | Drug | Aleglitazar |
Primary outcome
Pharmacokinetics: Area under the plasma concentration time curve
Time frame: Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12
1 secondary outcome
Safety: incidence of adverse events
Time frame: 14 weeks
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.
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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 and rifampicin in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United Kingdom.
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 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 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 United Kingdom. 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: Area under the plasma concentration time curve (time frame: Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12). 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.