Renal InsufficiencyPhase 1NCT01957657

Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients

A Phase 1 study testing BI 207127 and faldaprevir in people with Renal Insufficiency, run by Boehringer Ingelheim at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI 207127 and faldaprevir on day 4. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Renal Insufficiency
What is being tested?: BI 207127 and faldaprevir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteGermany
Study dates: Oct 2013to Dec 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 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy volunteers (males and females) or patients with impaired renal function (estimated glomerular filtration rate (eGFR) between 89 and 15) in relatively good health as determined by past medical history, physical examination, vital signs, ECG and laboratory assessments (aside from abnormalities specific for renal impairment)
Age from 18 to 79 years
Subjects must be able to understand and comply with study requirements

Who cannot join

Any relevant deviation from healthy conditions for healthy volunteers
Subjects with significant diseases other than renal impairment will be excluded. A significant disease is defined as a disease which in the opinion of the investigator:
put the patient at risk because of participation in the study
may influence the results of the study
may influence the patients ability to participate in the study
is not in a stable condition
Diabetic or hypertensive patients can be entered in this trial if the disease is not significant according to these criteria

Trial locations and contacts

1 site in 1 country.

Germany1 site

1241.32.1 Boehringer Ingelheim Investigational Site
Kiel

Other trials in Germany

About this study

Official title: Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Single Center, Open-label, Parallel-group, Phase I Trial

Conditions: Renal Insufficiency
Being tested: BI 207127, faldaprevir
Medical subject headings: Renal Insufficiency

What participants receive

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

BI 207127Drug
oral administration
faldaprevirDrug
oral administration
BI 207127Drug
oral administration
BI 207127Drug
oral administration
BI 207127Drug
oral administration
faldaprevirDrug
oral administration
faldaprevirDrug
oral administration
faldaprevirDrug
oral administration

Study groups in NCT01957657
Study group	Role	What they receive
Healthy volunteers group 1	Experimental	Healthy volunteers with normal renal function Receives: Drug: BI 207127; Drug: faldaprevir
Renal function group 2	Experimental	Patients with mild renal impairment Receives: Drug: BI 207127; Drug: faldaprevir
Renal function group 3	Experimental	Patients with moderate renal impairment Receives: Drug: BI 207127; Drug: faldaprevir
Renal function group 4	Experimental	Patients with severe renal impairment Receives: Drug: BI 207127; Drug: faldaprevir

What is being measured

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

AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4
Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4

Secondary outcomes (9)

Number (%) of Subjects With Drug-related Adverse Events
Number (percentage) of subjects with drug-related adverse events
Measured: From the first drug administration until last drug administration, up to 10 days
AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4
AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4
AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4
AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4
Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4
Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4
Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4
Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Measured: Day 4

Timeline

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

Oct 2013Dec 2013

First posted8 Oct 2013 (estimated)
Study startOct 2013
Primary completionDec 2013
Study completionDec 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal InsufficiencyStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01957657
Sponsor's protocol ID: 1241.32
Other IDs: 2013-001075-21
Status last verified: Mar 2016
First submitted: 1 Oct 2013
Last updated: 11 Apr 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Huang F, Moschetti V, Lang B, Halabi A, Petersen-Sylla M, Yong CL, Elgadi M. Pharmacokinetics, safety, and tolerability of faldaprevir in patients with renal impairment. Antimicrob Agents Chemother. 2015 Jan;59(1):251-7. doi: 10.1128/AAC.03359-14. Epub 2014 Oct 27.
PubMed 25348520

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 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Single Center, Open-label, Parallel-group, Phase I Trial
ClinicalTrials.gov ID: NCT01957657
Acronym / sponsor ID: 1241.32
Conditions: Renal Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 4 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 8 Oct 2013 (estimated)
Results: Posted 11 Apr 2016

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: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Healthy volunteers group 1	Experimental	Drug: BI 207127, Drug: faldaprevirHealthy volunteers with normal renal function
Renal function group 2	Experimental	Drug: BI 207127, Drug: faldaprevirPatients with mild renal impairment
Renal function group 3	Experimental	Drug: BI 207127, Drug: faldaprevirPatients with moderate renal impairment
Renal function group 4	Experimental	Drug: BI 207127, Drug: faldaprevirPatients with severe renal impairment

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy volunteers (males and females) or patients with impaired renal function (estimated glomerular filtration rate (eGFR) between 89 and 15) in relatively good health as determined by past medical history, physical examination, vital signs, ECG and laboratory assessments (aside from abnormalities specific for renal impairment)
Age from 18 to 79 years
Subjects must be able to understand and comply with study requirements

Key exclusion criteria (7 listed)

Any relevant deviation from healthy conditions for healthy volunteers
Subjects with significant diseases other than renal impairment will be excluded. A significant disease is defined as a disease which in the opinion of the investigator:
Diabetic or hypertensive patients can be entered in this trial if the disease is not significant according to these criteria

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
BI 207127oral administration	Drug	Renal function group 2
faldapreviroral administration	Drug	Renal function group 2
BI 207127oral administration	Drug	Renal function group 4
BI 207127oral administration	Drug	Healthy volunteers group 1
BI 207127oral administration	Drug	Renal function group 3
faldapreviroral administration	Drug	Renal function group 3
faldapreviroral administration	Drug	Healthy volunteers group 1
faldapreviroral administration	Drug	Renal function group 4

Primary outcome

AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Time frame: Day 4
Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.
Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)
Time frame: Day 4
Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.

9 secondary outcomes

Number (%) of Subjects With Drug-related Adverse Events
Time frame: From the first drug administration until last drug administration, up to 10 days
AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Time frame: Day 4
AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Time frame: Day 4
AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Time frame: Day 4
AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Time frame: Day 4
Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)
Time frame: Day 4
Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)
Time frame: Day 4
Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)
Time frame: Day 4
Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)
Time frame: Day 4

Results and safety

Results posted to the registry on 11 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deleobuvir + Faldaprevir, Mild Renal Impairment	4	4

Primary outcome: AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)

Time frame: Day 4

Population analysed: Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.

Primary outcome: Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)

Time frame: Day 4

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first drug administration until day after end of trial examination, up to 18 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deleobuvir + Faldaprevir, Mild Renal Impairment	0 of 4 (0%)	1 of 4 (25%)	Not reported

Limitations and caveats (from the sponsor): The sponsor decided to stop the development of Hepatitis C treatments and terminated the trial prematurely on 27 Dec 2013. Due to the small sample size the pharmacokinetic endpoints were not determined.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25348520Huang F, Moschetti V, Lang B, Halabi A, Petersen-Sylla M, Yong CL, Elgadi M. Pharmacokinetics, safety, and tolerability of faldaprevir in patients with renal impairment. Antimicrob Agents Chemother. 2015 Jan;59(1):251-7. doi: 10.1128/AAC.03359-14. Epub 2014 Oct 27.
Boehringer Ingelheim Global Clinical Trials WebsiteLink 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 BI 207127 and faldaprevir in people with Renal Insufficiency, 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 11 Apr 2016. 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 11 Apr 2016). 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 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (time frame: Day 4). 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 NCT01957657, 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 11 Apr 2016.