HealthyPhase 1NCT01795937

Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin

A Phase 1 study testing Itraconazole, Atorvastatin and Faldaprevir in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the effect of steady-state itraconazole on the pharmacokinetics of steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of rosuvastatin Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Itraconazole, Atorvastatin and Faldaprevir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteGermany
Study dates: Feb 2013to Mar 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy male and female subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1220.61.1 Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin in Healthy Male and Female Subjects (Open-label, Fixed-sequence)

Conditions: Healthy
Being tested: Itraconazole, Atorvastatin, Faldaprevir, Rosuvastatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ItraconazoleDrug
twice daily
AtorvastatinDrug
single dose
FaldaprevirDrug
once daily
RosuvastatinDrug
single dose
FaldaprevirDrug
once daily

Study groups in NCT01795937
Study group	Role	What they receive
Part 1: Faldaprevir + Itraconazole	Experimental	Interaction of Faldaprevir and Itraconazole Receives: Drug: Itraconazole; Drug: Faldaprevir
Part 2:Faldaprevir+Rosuvastatin+Atorvast	Experimental	Interaction of Faldaprevir, Rosuvastatin and Atorvastatin Receives: Drug: Atorvastatin; Drug: Faldaprevir; Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCτ,ss (Itraconazole Part)
Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods
Cmax,ss (Itraconazole Part)
Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.
AUC0-∞ of Atorvastatin (Statins Part)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.
Cmax of Atorvastatin (Statins Part)
Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods
AUC0-∞ of Rosuvastatin (Statins Part)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods
Cmax of Rosuvastatin
Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods

Secondary outcomes (4)

AUCτ,ss of Faldaprevir (Statins Part)
Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.
Cmax,ss of Faldaprevir (Statins Part)
Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.
AUC0-tz of Atorvastatin
Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C_D.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods
AUC0-tz of Rosuvastatin
Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Mar 2013

First posted21 Feb 2013 (estimated)
Study startFeb 2013
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01795937
Sponsor's protocol ID: 1220.61
Other IDs: 2012-005518-20
Status last verified: Jul 2015
First submitted: 20 Feb 2013
Last updated: 3 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin in Healthy Male and Female Subjects (Open-label, Fixed-sequence)
ClinicalTrials.gov ID: NCT01795937
Acronym / sponsor ID: 1220.61
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 21 Feb 2013 (estimated)
Results: Posted 3 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Part 1: Faldaprevir + Itraconazole	Experimental	Drug: Itraconazole, Drug: FaldaprevirInteraction of Faldaprevir and Itraconazole
Part 2:Faldaprevir+Rosuvastatin+Atorvast	Experimental	Drug: Atorvastatin, Drug: Faldaprevir, Drug: RosuvastatinInteraction of Faldaprevir, Rosuvastatin and Atorvastatin

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy male and female subjects

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions

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
Itraconazoletwice daily	Drug	Part 1: Faldaprevir + Itraconazole
Atorvastatinsingle dose	Drug	Part 2:Faldaprevir+Rosuvastatin+Atorvast
Faldaprevironce daily	Drug	Part 2:Faldaprevir+Rosuvastatin+Atorvast
Rosuvastatinsingle dose	Drug	Part 2:Faldaprevir+Rosuvastatin+Atorvast
Faldaprevironce daily	Drug	Part 1: Faldaprevir + Itraconazole

Primary outcome

AUCτ,ss (Itraconazole Part)
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods
Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Cmax,ss (Itraconazole Part)
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.
Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
AUC0-∞ of Atorvastatin (Statins Part)
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Cmax of Atorvastatin (Statins Part)
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods
Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
AUC0-∞ of Rosuvastatin (Statins Part)
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Cmax of Rosuvastatin
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods
Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

4 secondary outcomes

AUCτ,ss of Faldaprevir (Statins Part)
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.
Cmax,ss of Faldaprevir (Statins Part)
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.
AUC0-tz of Atorvastatin
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods
AUC0-tz of Rosuvastatin
Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods

Results and safety

Results posted to the registry on 3 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence A_B (Itraconazole Part)	18	17
Treatment Sequence C_D (Statins Part)	16	15
Treatment Sequence E_F (Statins Part)	17	17

Primary outcome: AUCτ,ss (Itraconazole Part)

Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Faldaprevir n = 17	Faldaprevir+Itraconazole n = 17
Value	29900 (62.8)	59500 (53.8)

Faldaprevir vs Faldaprevir+Itraconazole: Geometric Mean Ratio: 198.55 (90% CI 182.43 to 216.09), ANOVA

Population analysed: pharmacokinetic (PK) set of the itraconazole part of this trial. The PK set included all treated subjects of the itraconazole part that provided at least 1 observation for at least 1 primary endpoint without important protocal violations with respect to the statistical evaluation of the PK endpoints.

Primary outcome: Cmax,ss (Itraconazole Part)

Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Faldaprevir n = 17	Faldaprevir+Itraconazole n = 17
Value	2780 (61.0)	5030 (49.1)

Faldaprevir vs Faldaprevir+Itraconazole: Geometric Mean Ratio: 180.63 (90% CI 165.68 to 196.93), ANOVA

Population analysed: PK set of the itraconazole part of this trial.

Primary outcome: AUC0-∞ of Atorvastatin (Statins Part)

Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Atorvastatin n = 16	Atorvastatin+Faldaprevir n = 15
Value	13.7 (51.5)	129.0 (43.7)

Atorvastatin vs Atorvastatin+Faldaprevir: Geometric Mean Ratio: 946.45 (90% CI 797.61 to 1123.07), ANOVA

Population analysed: PK set of the statins part and assigned to atorvastatin (treatment sequence C\_D). Pharmacokinetic set (PK set): all treated subjects of the statins part that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.

Primary outcome: Cmax of Atorvastatin (Statins Part)

Time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Atorvastatin n = 16	Atorvastatin+Faldaprevir n = 15
Value	0.94 (35.2)	31.10 (52.5)

Atorvastatin vs Atorvastatin+Faldaprevir: Geometric Mean Ratio: 3372.72 (90% CI 2961.95 to 3840.47), ANOVA

Population analysed: PK set of the statins part and assigned to atorvastatin (treatment sequence C\_D).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Faldaprevir (Itraconazole Part)	0 of 18 (0%)	13 of 18 (72.2%)	Not reported
Faldaprevir+Itraconazole (Itraconazole Part)	0 of 17 (0%)	3 of 17 (17.6%)	Not reported
Atorvastatin (Statins Part)	0 of 16 (0%)	5 of 16 (31.3%)	Not reported
Rosuvastatin (Statins Part)	0 of 17 (0%)	4 of 17 (23.5%)	Not reported
Faldaprevir (Statins Part)	0 of 32 (0%)	23 of 32 (71.9%)	Not reported
Faldaprevir + Atorvastatin (Statins Part)	0 of 15 (0%)	8 of 15 (53.3%)	Not reported
Faldaprevir + Rosuvastatin (Statins Part)	0 of 17 (0%)	9 of 17 (52.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 Itraconazole, Atorvastatin and Faldaprevir in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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 1 inclusion and 1 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 3 Aug 2015. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 3 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

AUCτ,ss (Itraconazole Part) (time frame: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods). 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?

On the ClinicalTrials.gov record for NCT01795937.

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 3 Aug 2015.