Hepatitis CPhase 1NCT01336829
TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.
A Phase 1 study testing ETR/telaprevir, TMC278/telaprevir and telaprevir/ETR in people with Hepatitis C and HIV, run by Tibotec Pharmaceuticals, Ireland at 1 site in Belgium.
Trial summary
The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, HIV
- What is being tested?
- ETR/telaprevir, TMC278/telaprevir and telaprevir/ETR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2011to Sep 2011
- 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
- Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
- A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2
- Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at Screening
- Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study, or have a vasectomized partner, or if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control.
Who cannot join
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
- A positive urine drug test at Screening
- Use of disallowed therapies: concomitant medication, including over-the-counter products, herbal preparations and dietary supplements
- History of significant drug allergy
- Received an investigational drug or used an investigational medical device within 60 days preceding the first intake of study medication or having previously participated in a study with either ETR, TMC278, telaprevir.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Randomized, 2-Panel, 2-Way Crossover Trial to Investigate the Pharmacokinetic Interaction Between Etravirine or TMC278 and Telaprevir at Steady-State in Healthy Subjects.
The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.
Read the detailed description
This is an open-label, randomized, single-dose, crossover trial in healthy volunteers. Crossover means that participants may receive different interventions sequentially during the trial. Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin. Open-label means that you and your physician will know what treatment you will receive. The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase. Total study duration for an individual participant will be approximately 11 weeks. Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase. In the first part, a group of 16 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance. In treatment A, 200 mg (2 tablets) ETR (etravirine) will be given twice a day from day 1 to 10 with a morning dose only on day 11. In treatment B, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 17 every 8 hours with a morning and afternoon dose only on day 18 and 200 mg ETR will be given twice a day from day 8 to 17 with a morning dose on day 18. In between the 2 sessions, there will be at least 14 days. In the second part, another group of 16 participants will receive 2 treatment sessions, C and D. The order in which these treatments are given will be determined by chance. In treatment C, 25 mg (1 tablet) TMC278 will be given once a day from day 1 to 11. In treatment D, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 18 every 8 hours and 25 mg TMC278 will be given once a day from day 8 to 18. In between the 2 sessions, there will be at least 14 days. All treatments will be taken food. In treatments A and C, participants will come to the unit the day before dosing and in the mornings of day 1, 9 and 10 and for a whole day on day 11. Only in treatment C, overnight stay from day 11 to day 12 is foreseen. In treatment B, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 16 and 17 and for a whole day on days 7 and 18. In treatment D, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 12, 16 and 17 and for a whole day on days 7 and 18 with overnight stay from day 18 to 19. Five to 7 days after last dosing, participants will have a last follow-up visit at the unit (follow-up phase). During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drugs). In treatment A, 2 tablets ETR will be given twice a day from day 1 to 10 with a morning dose on day 11. In treatment B, 2 tablets TVR will be given every 8 hours from day 1 to17 with only 2 doses on day 18 and 2 tablets ETR twice a day from day 8 to 17 with a morning dose only on day 18. In treatment C, 1 tablet TMC278 will be given oncy a day from day 1 to 11. In treatment D, 2 tablets of TVR will be given every 8 hours from day 1 to 18 and 1 tablet TMC278 once a day from day 8 to 18.
- Conditions
- Hepatitis C, HIV
- Being tested
- ETR/telaprevir, TMC278/telaprevir, telaprevir/ETR, telaprevir/TMC278
- Keywords
- Hepatitis C, HIV, TMC125IFD1001, TMC125, Intelence, etravirine, ETR, TMC278, telaprevir, TVR, VX-950, healthy volunteers, crossover
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETR/telaprevirDrug
Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
TMC278/telaprevirDrug
Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.
telaprevir/ETRDrug
Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
telaprevir/TMC278Drug
Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | ETR/telaprevir Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18 and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18. Receives: Drug: ETR/telaprevir |
| 002 | Experimental | telaprevir/ETR Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18 and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18. Receives: Drug: telaprevir/ETR |
| 003 | Experimental | TMC278/telaprevir Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18 and TMC278 25 mg once daily from Day 8 to Day 18. Receives: Drug: TMC278/telaprevir |
| 004 | Experimental | telaprevir/TMC278 Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18 and TMC278 25 mg once daily from Day 8 to Day 18. Receives: Drug: telaprevir/TMC278 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bloodlevels of telaprevir following co-administration with ETR
Measured: Over 8 hours on day 18 of treatment B.
Bloodlevels of telaprevir following co-administration with TMC278
Measured: Over 8 hours on day 18 of treatment B.
Bloodlevels of ETR following co-administration with telaprevir
Measured: Over 12 hours on day 18 of treatment B.
Bloodlevels of TMC278 following co-administration with telaprevir
Measured: Over 24 hours on day 18 of treatment D
Secondary outcomes (6)
Number of participants with adverse events and the severity of adverse events
Measured: Over approximately 11 weeks
Bloodlevels of ETR in function of variations of 2 genes (CYP2C9 and CYP2C19)
Measured: 1 bloodsample on day 1 of treatment A.
Observed values and changes from baseline for abnormal values of laboratory results.
Measured: Over approximately 11 weeks
Observed values and changes from baseline for electrocardiograms (interpretation of electrical activity of the heart)
Measured: Over approximately 11 weeks
Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits
Measured: Over approximately 11 weeks
Physical examination findings and changes from baseline.
Measured: Over approximately 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec Pharmaceuticals Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336829
- Sponsor's protocol ID
- CR017989
- Other IDs
- TMC125IFD1001
- Status last verified
- Aug 2012
- First submitted
- 7 Apr 2011
- Last updated
- 29 Aug 2012
- Results posted
- No
Publications
Kakuda TN, Leopold L, Nijs S, Vandevoorde A, Crauwels HM, Bertelsen KM, Stevens M, Witek J, van Delft Y, Tomaka F, Hoetelmans RM. Pharmacokinetic interaction between etravirine or rilpivirine and telaprevir in healthy volunteers: A randomized, two-way crossover trial. J Clin Pharmacol. 2014 May;54(5):563-73. doi: 10.1002/jcph.245.
PubMed 25975423
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Randomized, 2-Panel, 2-Way Crossover Trial to Investigate the Pharmacokinetic Interaction Between Etravirine or TMC278 and Telaprevir at Steady-State in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01336829
- Acronym / sponsor ID
- CR017989
- Conditions
- Hepatitis C, HIV
- Keywords
- Hepatitis C, HIV, TMC125IFD1001, TMC125, Intelence, etravirine, ETR, TMC278
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Apr 2011 (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 this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.
Detailed description
This is an open-label, randomized, single-dose, crossover trial in healthy volunteers. Crossover means that participants may receive different interventions sequentially during the trial. Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin. Open-label means that you and your physician will know what treatment you will receive. The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase. Total study duration for an individual participant will be approximately 11 weeks. Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase. In the first part, a group of 16 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance. In treatment A, 200 mg (2 tablets) ETR (etravirine) will be given twice a day from day 1 to 10 with a morning dose only on day 11. In treatment B, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 17 every 8 hours with a morning and afternoon dose only on day 18 and 200 mg ETR will be given twice a day from day 8 to 17 with a morning dose on day 18. In between the 2 sessions, there will be at least 14 days. In the second part, another group of 16 participants will receive 2 treatment sessions, C and D. The order in which these treatments are given will be determined by chance. In treatment C, 25 mg (1 tablet) TMC278 will be given once a day from day 1 to 11. In treatment D, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 18 every 8 hours and 25 mg TMC278 will be given once a day from day 8 to 18. In between the 2 sessions, there will be at least 14 days. All treatments will be taken food. In treatments A and C, participants will come to the unit the day before dosing and in the mornings of day 1, 9 and 10 and for a whole day on day 11. Only in treatment C, overnight stay from day 11 to day 12 is foreseen. In treatment B, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 16 and 17 and for a whole day on days 7 and 18. In treatment D, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 12, 16 and 17 and for a whole day on days 7 and 18 with overnight stay from day 18 to 19. Five to 7 days after last dosing, participants will have a last follow-up visit at the unit (follow-up phase). During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drugs). In treatment A, 2 tablets ETR will be given twice a day from day 1 to 10 with a morning dose on day 11. In treatment B, 2 tablets TVR will be given every 8 hours from day 1 to17 with only 2 doses on day 18 and 2 tablets ETR twice a day from day 8 to 17 with a morning dose only on day 18. In treatment C, 1 tablet TMC278 will be given oncy a day from day 1 to 11. In treatment D, 2 tablets of TVR will be given every 8 hours from day 1 to 18 and 1 tablet TMC278 once a day from day 8 to 18.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: ETR/telaprevirETR/telaprevir Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18 and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18. |
| 002 | Experimental | Drug: telaprevir/ETRtelaprevir/ETR Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18 and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18. |
| 003 | Experimental | Drug: TMC278/telaprevirTMC278/telaprevir Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18 and TMC278 25 mg once daily from Day 8 to Day 18. |
| 004 | Experimental | Drug: telaprevir/TMC278telaprevir/TMC278 Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18 and TMC278 25 mg once daily from Day 8 to Day 18. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
- A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2
- Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at Screening
- Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study, or have a vasectomized partner, or if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control.
Key exclusion criteria (5 listed)
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
- A positive urine drug test at Screening
- Use of disallowed therapies: concomitant medication, including over-the-counter products, herbal preparations and dietary supplements
- History of significant drug allergy
- Received an investigational drug or used an investigational medical device within 60 days preceding the first intake of study medication or having previously participated in a study with either ETR, TMC278, telaprevir.
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 |
|---|---|---|
| ETR/telaprevirTreatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18. | Drug | 001 |
| TMC278/telaprevirTreatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18. | Drug | 003 |
| telaprevir/ETRTreatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18. | Drug | 002 |
| telaprevir/TMC278Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18. | Drug | 004 |
Primary outcome
Bloodlevels of telaprevir following co-administration with ETR
Time frame: Over 8 hours on day 18 of treatment B.
Bloodlevels of telaprevir following co-administration with TMC278
Time frame: Over 8 hours on day 18 of treatment B.
Bloodlevels of ETR following co-administration with telaprevir
Time frame: Over 12 hours on day 18 of treatment B.
Bloodlevels of TMC278 following co-administration with telaprevir
Time frame: Over 24 hours on day 18 of treatment D
6 secondary outcomes
Number of participants with adverse events and the severity of adverse events
Time frame: Over approximately 11 weeks
Bloodlevels of ETR in function of variations of 2 genes (CYP2C9 and CYP2C19)
Time frame: 1 bloodsample on day 1 of treatment A.
Observed values and changes from baseline for abnormal values of laboratory results.
Time frame: Over approximately 11 weeks
Observed values and changes from baseline for electrocardiograms (interpretation of electrical activity of the heart)
Time frame: Over approximately 11 weeks
Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits
Time frame: Over approximately 11 weeks
Physical examination findings and changes from baseline.
Time frame: Over approximately 11 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 29 Aug 2012.
- Derived from this study: PubMed 25975423Kakuda TN, Leopold L, Nijs S, Vandevoorde A, Crauwels HM, Bertelsen KM, Stevens M, Witek J, van Delft Y, Tomaka F, Hoetelmans RM. Pharmacokinetic interaction between etravirine or rilpivirine and telaprevir in healthy volunteers: A randomized, two-way crossover trial. J Clin Pharmacol. 2014 May;54(5):563-73. doi: 10.1002/jcph.245.
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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.
Tibotec Pharmaceuticals Clinical Trial study director
Tibotec Pharmaceutical Limited
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 ETR/telaprevir, TMC278/telaprevir and telaprevir/ETR in people with Hepatitis C and HIV, run by Tibotec Pharmaceuticals, Ireland at 1 site in Belgium.
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 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 29 Aug 2012. 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 Belgium. 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?
Bloodlevels of telaprevir following co-administration with ETR (time frame: Over 8 hours on day 18 of treatment B.). 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?
On the ClinicalTrials.gov record for NCT01336829, which also lists 1 linked publication.
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 Aug 2012.