Healthy ParticipantsPhase 1NCT01719614
A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants
A Phase 1 study testing Metformin and Rilpivirine in people with Healthy Participants, run by Janssen R&D Ireland at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within the body, and removed from the body) of a single dose of metformin, over time, in healthy… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Metformin and Rilpivirine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jan 2013
- 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
- Participants should be healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis performed at screening
- Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2
- Male participants should agree to protocol-defined use of effective contraception and women must be postmenopausal or surgically sterile
- Female participants must have a negative pregnancy test at screening
- Participants must be non-smoking for at least 3 months prior to screening
Who cannot join
- A positive Human immunodeficiency virus (HIV)-1 or HIV-2 test and Hepatitis A, B or C infection at screening
- Currently active clinically significant gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrine, renal, hepatic, respiratory, inflammatory or infectious disease with any history of clinically significant skin disease
- Any history of tuberculosis, ocular herpes, or uveitis
- Have previously participated in more than one study with etravirine - TMC120 (dapivirine) and/or rilpivirine
- Participants with abnormal laboratory values at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label Study in Healthy Subjects to Explore the Potential for a Pharmacokinetic Interaction Between Steady-State Rilpivirine and a Single Dose Of Metformin
The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within the body, and removed from the body) of a single dose of metformin, over time, in healthy adult participants.
Read the detailed description
This is a phase I, open-label (all people know the identity of the intervention) and sequential study (study medication is given in a sequence) in healthy participants, to investigate the pharmacokinetic interaction between steady-state rilpivirine and a single dose of metformin. The study consists of 3 phases including, the screening phase (28 days before enrollment), treatment phase (19 days), and the follow-up phase (7 days after the last intake of study medication). All participants will receive study medications in two sessions in a fixed, sequential order as a session 1 (a single dose of metformin on Day 1) followed by washout period (period when no treatment is received) of 4 days and then session 2 (rilpivirine on Day 5 to Day 17 with a single dose of metformin on Day 15). The duration of the study is approximately 54 days. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination (including skin examination) will be monitored throughout the study.
- Conditions
- Healthy Participants
- Being tested
- Metformin, Rilpivirine
- Keywords
- Healthy participants, Rilpivirine, Metformin, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Type=exact number, unit=mg, number=850, form=tablet, route=oral. Participants will receive single dose of metformin on Day 1 and Day 15.
RilpivirineDrug
Type=exact number, unit=mg, number=25, form=tablet route=oral. Participants will receive 1 tablet of rilpivirine from Day 5 to Day 17.
| Study group | Role | What they receive |
|---|---|---|
| Rilpivirine+Metformin | Experimental | All participants will receive study medications in two sessions in a fixed, sequential order as a session 1 (a single dose of metformin on Day 1) followed by washout period (period when no treatment is received) of 4 days and then session 2 (rilpivirine on Day 5 to Day 17 with a single dose of metformin on Day 15). Receives: Drug: Metformin; Drug: Rilpivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma analyte concentration (Cmax) of metformin
Measured: Day 1 and Day 15
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of metformin
Measured: Day 1 and Day 15
Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration after dosing (AUClast) of metformin
Measured: Day 1 and Day 15
AUC extrapolated to infinity of metformin
AUC extrapolated to infinity, calculated as AUClast + Clast/apparent terminal elimination rate constant, where Clast is the last measurable plasma analyte concentration; extrapolations of more than 20 percent of the total AUC are reported as approximations.
Measured: Day 1 and Day 15
Apparent terminal elimination rate constant of metformin
Apparent terminal elimination rate constant will be estimated by linear regression using the terminal log-linear phase of the logarithmic transformed conentration versus time data.
Measured: Day 1 and Day 15
Apparent terminal elimination half-life of metformin
Measured: Day 1 and Day 15
Secondary outcomes (9)
Predose plasma analyte concentration (C0h) of rilpivirine
Measured: Day 12, Day 13, Day 14, Day 15, Day 17, Day 18
Minimum observed plasma analyte concentration (Cmin) of rilpivirine
Measured: Day 15
Maximum observed plasma analyte concentration (Cmax) of rilpivirine
Measured: Day 15
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of rilpivirine
Measured: Day 15
Observed plasma analyte concentration at the end of the 24-hour dosing interval (C24h)
Measured: Day 15
AUC from time of administration up to 24 hours after administration (AUC24h)
Measured: Day 15
Average steady-state plasma concentration (Css,av)
Css,av is calculated by AUC dosing interval/dosing interval at steady-state
Measured: Day 15
Fluctuation index (FI)
FI, percentage fluctuation is variation between maximum and minimum plasma concentration at steady-state
Measured: Day 15
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 54 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen R&D Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen R&D Ireland Clinical Trial, Study director, Janssen R&D Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719614
- Sponsor's protocol ID
- CR100909
- Other IDs
- TMC278IFD1004
- Status last verified
- Mar 2014
- First submitted
- 30 Oct 2012
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study in Healthy Subjects to Explore the Potential for a Pharmacokinetic Interaction Between Steady-State Rilpivirine and a Single Dose Of Metformin
- ClinicalTrials.gov ID
- NCT01719614
- Acronym / sponsor ID
- CR100909
- Conditions
- Healthy Participants
- Keywords
- Healthy participants, Rilpivirine, Metformin, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Janssen R&D IrelandIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Nov 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.
The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within the body, and removed from the body) of a single dose of metformin, over time, in healthy adult participants.
Detailed description
This is a phase I, open-label (all people know the identity of the intervention) and sequential study (study medication is given in a sequence) in healthy participants, to investigate the pharmacokinetic interaction between steady-state rilpivirine and a single dose of metformin. The study consists of 3 phases including, the screening phase (28 days before enrollment), treatment phase (19 days), and the follow-up phase (7 days after the last intake of study medication). All participants will receive study medications in two sessions in a fixed, sequential order as a session 1 (a single dose of metformin on Day 1) followed by washout period (period when no treatment is received) of 4 days and then session 2 (rilpivirine on Day 5 to Day 17 with a single dose of metformin on Day 15). The duration of the study is approximately 54 days. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination (including skin examination) will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rilpivirine+Metformin | Experimental | Drug: Metformin, Drug: RilpivirineAll participants will receive study medications in two sessions in a fixed, sequential order as a session 1 (a single dose of metformin on Day 1) followed by washout period (period when no treatment is received) of 4 days and then session 2 (rilpivirine on Day 5 to Day 17 with a single dose of metformin on Day 15). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants should be healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis performed at screening
- Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2
- Male participants should agree to protocol-defined use of effective contraception and women must be postmenopausal or surgically sterile
- Female participants must have a negative pregnancy test at screening
- Participants must be non-smoking for at least 3 months prior to screening
Key exclusion criteria (5 listed)
- A positive Human immunodeficiency virus (HIV)-1 or HIV-2 test and Hepatitis A, B or C infection at screening
- Currently active clinically significant gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrine, renal, hepatic, respiratory, inflammatory or infectious disease with any history of clinically significant skin disease
- Any history of tuberculosis, ocular herpes, or uveitis
- Have previously participated in more than one study with etravirine - TMC120 (dapivirine) and/or rilpivirine
- Participants with abnormal laboratory values at screening
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 |
|---|---|---|
| MetforminType=exact number, unit=mg, number=850, form=tablet, route=oral. Participants will receive single dose of metformin on Day 1 and Day 15. | Drug | Rilpivirine+Metformin |
| RilpivirineType=exact number, unit=mg, number=25, form=tablet route=oral. Participants will receive 1 tablet of rilpivirine from Day 5 to Day 17. | Drug | Rilpivirine+Metformin |
Primary outcome
Maximum observed plasma analyte concentration (Cmax) of metformin
Time frame: Day 1 and Day 15
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of metformin
Time frame: Day 1 and Day 15
Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration after dosing (AUClast) of metformin
Time frame: Day 1 and Day 15
AUC extrapolated to infinity of metformin
Time frame: Day 1 and Day 15
AUC extrapolated to infinity, calculated as AUClast + Clast/apparent terminal elimination rate constant, where Clast is the last measurable plasma analyte concentration; extrapolations of more than 20 percent of the total AUC are reported as approximations.
Apparent terminal elimination rate constant of metformin
Time frame: Day 1 and Day 15
Apparent terminal elimination rate constant will be estimated by linear regression using the terminal log-linear phase of the logarithmic transformed conentration versus time data.
Apparent terminal elimination half-life of metformin
Time frame: Day 1 and Day 15
9 secondary outcomes
Predose plasma analyte concentration (C0h) of rilpivirine
Time frame: Day 12, Day 13, Day 14, Day 15, Day 17, Day 18
Minimum observed plasma analyte concentration (Cmin) of rilpivirine
Time frame: Day 15
Maximum observed plasma analyte concentration (Cmax) of rilpivirine
Time frame: Day 15
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of rilpivirine
Time frame: Day 15
Observed plasma analyte concentration at the end of the 24-hour dosing interval (C24h)
Time frame: Day 15
AUC from time of administration up to 24 hours after administration (AUC24h)
Time frame: Day 15
Average steady-state plasma concentration (Css,av)
Time frame: Day 15
Fluctuation index (FI)
Time frame: Day 15
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 54 Days
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 6 Mar 2014.
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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.
Janssen R&D Ireland Clinical Trial study director
Janssen R&D Ireland
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 Metformin and Rilpivirine in people with Healthy Participants, run by Janssen R&D Ireland at 1 site in United States.
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 5 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 6 Mar 2014. 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 States. 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?
Maximum observed plasma analyte concentration (Cmax) of metformin (time frame: Day 1 and Day 15). The study lists 6 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 6 Mar 2014.