HealthyPhase 1NCT01785160

Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

A Phase 1 study testing Raltegravir 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

The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir. The assessment of safety and tolerability will be an additional objective of this trial. 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?: Raltegravir and Faldaprevir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 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 subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1220.65.1 Boehringer Ingelheim Investigational Site
Mannheim

Other trials in Germany

About this study

Official title: Investigation of Faldaprevir Effect on Steady State Pharmacokinetics of Raltegravir in Healthy Male and Female Volunteers (an Open-label Trial With Two Periods in a Fixed Sequence)

The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir.

The assessment of safety and tolerability will be an additional objective of this trial.

Conditions: Healthy
Being tested: Raltegravir, Faldaprevir

What participants receive

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

RaltegravirDrug
low dose oral administration
RaltegravirDrug
low dose oral administration
FaldaprevirDrug
medium dose oral administration

Study groups in NCT01785160
Study group	Role	What they receive
Raltegravir	Active comparator	coated tablets, oral administration with 240 ml water Receives: Drug: Raltegravir
Raltegravir + Faldaprevir	Experimental	coated tablets and soft gelatine capsule, oral administration with 240 ml water Receives: Drug: Raltegravir; Drug: Faldaprevir

What is being measured

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

AUC( Tau,ss)
AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated.
The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'.
RAL: Raltegravir , FDV: Faldaprevir
Measured: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration
Cmax ,ss
C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated.
The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'.
RAL: Raltegravir , FDV: Faldaprevir
Measured: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration

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 posted7 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: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01785160
Sponsor's protocol ID: 1220.65
Other IDs: 2012-004872-21
Status last verified: Jul 2015
First submitted: 13 Dec 2012
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?

See locations

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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 Faldaprevir Effect on Steady State Pharmacokinetics of Raltegravir in Healthy Male and Female Volunteers (an Open-label Trial With Two Periods in a Fixed Sequence)
ClinicalTrials.gov ID: NCT01785160
Acronym / sponsor ID: 1220.65
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 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: 7 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.

The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir.

The assessment of safety and tolerability will be an additional objective of this trial.

Study design

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

Arm	Type	Receives
Raltegravir	Active comparator	Drug: Raltegravircoated tablets, oral administration with 240 ml water
Raltegravir + Faldaprevir	Experimental	Drug: Raltegravir, Drug: Faldaprevircoated tablets and soft gelatine capsule, oral administration with 240 ml water

Who may qualify

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

Key inclusion criteria (1 listed)

1. healthy male 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
Raltegravirlow dose oral administration	Drug	Raltegravir
Raltegravirlow dose oral administration	Drug	Raltegravir + Faldaprevir
Faldaprevirmedium dose oral administration	Drug	Raltegravir + Faldaprevir

Primary outcome

AUC( Tau,ss)
Time frame: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration
AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir
Cmax ,ss
Time frame: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration
C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated. The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'. RAL: Raltegravir , FDV: Faldaprevir

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
Overall Study	25	24

Primary outcome: AUC( Tau,ss)

Time frame: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Raltegravir n = 24	Raltegravir + Faldaprevir n = 23
Value	4070 (92.9)	11100 (78.7)

Raltegravir vs Raltegravir + Faldaprevir: Adjusted Geometric Mean ratio: 272.06 (95% CI 199.69 to 370.66), p = 0.9999, ANOVA

Population analysed: Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods

Primary outcome: Cmax ,ss

Time frame: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Raltegravir n = 24	Raltegravir + Faldaprevir n = 23
Value	1300 (115)	3220 (108)

Raltegravir vs Raltegravir + Faldaprevir: Adjusted Geometric Mean ratio: 245.72 (95% CI 168.460 to 358.404), p = 0.9973, ANOVA

Adverse events

Time frame: Up to 23 days (+1day). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Raltegravir	0 of 24 (0%)	6 of 24 (25%)	Not reported
Raltegravir + Faldaprevir	0 of 23 (0%)	13 of 23 (56.5%)	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 Raltegravir 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?

AUC( Tau,ss) (time frame: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration). 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?

On the ClinicalTrials.gov record for NCT01785160.

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.