HealthyPhase 1NCT01694706

Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir

A Phase 1 study testing faldaprevir and omeprazole 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 the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir. 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?: faldaprevir and omeprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteGermany
Study dates: Sep 2012to Dec 2012
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 condition

Trial locations and contacts

1 site in 1 country.

Germany1 site

1220.59.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Investigation of the Effect of Food and of Increased Gastric pH on the Relative Bioavailability of a Single Oral Dose of 240 mg Faldaprevir in an Open-label, Randomised, Three-way Cross-over Trial in Healthy Subjects

The primary objective of this trial is to investigate the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.

Conditions: Healthy
Being tested: faldaprevir, omeprazole

What participants receive

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

faldaprevirDrug
medium dose of faldaprevir
faldaprevirDrug
medium dose of faldaprevir
omeprazoleDrug
medium dose of omeprazole
faldaprevirDrug
medium dose of faldaprevir

Study groups in NCT01694706
Study group	Role	What they receive
Reference	Experimental	faldaprevir medium, fasted Receives: Drug: faldaprevir
Test 1	Active comparator	faldaprevir medium, fed Receives: Drug: faldaprevir
Test 2	Active comparator	faldaprevir medium + omeprazole medium Receives: Drug: omeprazole; Drug: faldaprevir

What is being measured

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

Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration
Faldaprevir: Maximum Measured Concentration (Cmax)
Maximum measured concentration of the faldaprevir in plasma
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration

Secondary outcomes (1)

Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration

Timeline

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

Sep 2012Dec 2012

First posted27 Sep 2012 (estimated)
Study startSep 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.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01694706
Sponsor's protocol ID: 1220.59
Other IDs: 2012-002941-39
Status last verified: Jul 2015
First submitted: 24 Sep 2012
Last updated: 30 Jul 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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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effect of Food and of Increased Gastric pH on the Relative Bioavailability of a Single Oral Dose of 240 mg Faldaprevir in an Open-label, Randomised, Three-way Cross-over Trial in Healthy Subjects
ClinicalTrials.gov ID: NCT01694706
Acronym / sponsor ID: 1220.59
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 27 Sep 2012 (estimated)
Results: Posted 30 Jul 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 the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Reference	Experimental	Drug: faldaprevirfaldaprevir medium, fasted
Test 1	Active comparator	Drug: faldaprevirfaldaprevir medium, fed
Test 2	Active comparator	Drug: omeprazole, Drug: faldaprevirfaldaprevir medium + omeprazole medium

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 condition

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
faldaprevirmedium dose of faldaprevir	Drug	Test 1
faldaprevirmedium dose of faldaprevir	Drug	Reference
omeprazolemedium dose of omeprazole	Drug	Test 2
faldaprevirmedium dose of faldaprevir	Drug	Test 2

Primary outcome

Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration
Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Faldaprevir: Maximum Measured Concentration (Cmax)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration
Maximum measured concentration of the faldaprevir in plasma In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

1 secondary outcome

Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration

Results and safety

Results posted to the registry on 30 Jul 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
Faldaprevir/Faldaprevir+ OMP/Faldaprevir Fed	5	4
Faldaprevir Fed/ Faldaprevir/ Faldaprevir+ OMP	5	4
Faldaprevir+ OMP/ Faldaprevir Fed/ Faldaprevir	5	5

Primary outcome: Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)

Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: [ng*h/mL]

Measure	Faldaprevir in Fasting n = 14	Faldaprevir After a High-fat Meal n = 14	Faldaprevir and Omeprazole n = 14
Value	37900 (67.2)	48200 (41.7)	36000 (63.4)

Faldaprevir in Fasting vs Faldaprevir After a High-fat Meal: Geometric Mean Ratio: 120.35 (90% CI 102.09 to 141.88), p = 0.3420, ANOVA
Faldaprevir in Fasting vs Faldaprevir and Omeprazole: Geometric Mean Ratio: 94.33 (90% CI 76.21 to 116.76), p = 0.0962, ANOVA

Population analysed: Pharmacokinetic (PK) set: Included all treated subjects 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: Faldaprevir: Maximum Measured Concentration (Cmax)

Measure	Faldaprevir in Fasting n = 14	Faldaprevir After a High-fat Meal n = 14	Faldaprevir and Omeprazole n = 14
Value	2030 (140)	2600 (57.5)	1920 (122)

Faldaprevir in Fasting vs Faldaprevir After a High-fat Meal: Geometric Mean Ratio: 118.79 (90% CI 83.190 to 169.628), p = 0.3993, ANOVA
Faldaprevir in Fasting vs Faldaprevir and Omeprazole: Geometric Mean Ratio: 93.55 (90% CI 65.783 to 133.030), p = 0.2204, ANOVA

Population analysed: PK set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first drug administration until the end of trial visit, up until 20 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Faldaprevir in Fasting	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
Faldaprevir After a High-fat Meal	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
Faldaprevir and Omeprazole	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
Omeprazole	0 of 15 (0%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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 faldaprevir and omeprazole 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 30 Jul 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 30 Jul 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?

Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) (time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug 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 NCT01694706.

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 30 Jul 2015.