Hepatitis CPhase 1NCT01580306

Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment

A Phase 1 study testing BI 201335 in people with Hepatitis C, 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.

Trial summary

The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis C
What is being tested?: BI 201335
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteGermany
Study dates: Apr 2012to Jun 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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female healthy subjects with normal renal function and subjects with impaired renal function in relatively good health

Who cannot join

Any relevant deviation from healthy conditions for healthy volunteers or significant diseases other than renal impairment for the renal impaired subjects

Trial locations and contacts

1 site in 1 country.

Germany1 site

1220.58.1 Boehringer Ingelheim Investigational Site
Kiel

Other trials in Germany

About this study

Official title: Pharmacokinetics, Safety and Tolerability of BI 201335 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase I Trial

Conditions: Hepatitis C
Being tested: BI 201335
Medical subject headings: Hepatitis C

What participants receive

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

BI 201335Drug
Relevant treatment dose capsule (A) for oral administration
BI 201335Drug
Relevant treatment dose capsule (B) for oral administration

Study groups in NCT01580306
Study group	Role	What they receive
BI 201335 relevant treatment dose (A)	Experimental	Capsule for oral administration Receives: Drug: BI 201335
BI 201335 relevant treatment dose (B)	Experimental	Capsule for oral administration Receives: Drug: BI 201335

What is being measured

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

AUC0-∞
area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.
In this endpoint, the data of AUC0-∞ show inter-individual variabilities.
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration
Cmax
maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration

Secondary outcomes (2)

Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG
Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Measured: from drug administration up to 2 weeks
Number of Participants With Drug Related Adverse Events
number of participants with investigator-defined drug related adverse events.
Measured: drug administration until end-of-study examination (7 to 14 days after drug administration)

Timeline

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

Apr 2012Jun 2012

First posted19 Apr 2012 (estimated)
Study startApr 2012
Primary completionJun 2012
Study completionJun 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 Hepatitis CStudies 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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01580306
Sponsor's protocol ID: 1220.58
Other IDs: 2011-005442-35
Status last verified: Jul 2015
First submitted: 12 Apr 2012
Last updated: 31 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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Evaluation of Patients With Liver Disease
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Hepatitis C in Substance Users
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Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety and Tolerability of BI 201335 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase I Trial
ClinicalTrials.gov ID: NCT01580306
Acronym / sponsor ID: 1220.58
Conditions: Hepatitis C
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 19 Apr 2012 (estimated)
Results: Posted 31 Jul 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: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BI 201335 relevant treatment dose (A)	Experimental	Drug: BI 201335Capsule for oral administration
BI 201335 relevant treatment dose (B)	Experimental	Drug: BI 201335Capsule for oral administration

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Male and female healthy subjects with normal renal function and subjects with impaired renal function in relatively good health

Key exclusion criteria (1 listed)

Any relevant deviation from healthy conditions for healthy volunteers or significant diseases other than renal impairment for the renal impaired subjects

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 201335Relevant treatment dose capsule (A) for oral administration	Drug	BI 201335 relevant treatment dose (A)
BI 201335Relevant treatment dose capsule (B) for oral administration	Drug	BI 201335 relevant treatment dose (B)

Primary outcome

AUC0-∞
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration
area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity. In this endpoint, the data of AUC0-∞ show inter-individual variabilities.
Cmax
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration
maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.

2 secondary outcomes

Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG
Time frame: from drug administration up to 2 weeks
Number of Participants With Drug Related Adverse Events
Time frame: drug administration until end-of-study examination (7 to 14 days after drug administration)

Results and safety

Results posted to the registry on 31 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
Normal Renal Function	8	8
Mild Renal Impairment	8	8
Moderate Renal Impairment	8	8
Severe Renal Impairment	8	8

Primary outcome: AUC0-∞

Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Normal Renal Function n = 5	Mild Renal Impairment n = 4	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 8
Value	76500 (95.7)	86900 (89.8)	136000 (67.2)	129000 (98.8)

Normal Renal Function vs Mild Renal Impairment: Geometric Mean Ratio: 113.57 (90% CI 41.58 to 310.17), ANOVA
Normal Renal Function vs Moderate Renal Impairment: Geometric Mean Ratio: 178.31 (90% CI 85.23 to 373.03), ANOVA
Normal Renal Function vs Severe Renal Impairment: Geometric Mean Ratio: 169.21 (90% CI 73.19 to 391.17), ANOVA

Population analysed: Pharmacokinetic (PK) set: This subject set included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK, and who did not vomit at or before 2 times median tmax of unmetabolised faldaprevir.

Primary outcome: Cmax

Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Normal Renal Function n = 5	Mild Renal Impairment n = 4	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 8
Value	3810 (80.7)	4080 (144.0)	6680 (63.2)	4600 (135.0)

Normal Renal Function vs Mild Renal Impairment: Geometric Mean Ratio: 107.22 (90% CI 35.16 to 327.01), ANOVA
Normal Renal Function vs Moderate Renal Impairment: Geometric Mean Ratio: 175.52 (90% CI 89.55 to 344.06), ANOVA
Normal Renal Function vs Severe Renal Impairment: Geometric Mean Ratio: 120.98 (90% CI 47.257 to 309.736), ANOVA

Population analysed: PK set

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 201335 Relevant Treatment Dose (Normal Renal Function)	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
BI 201335 Relevant Treatment Dose (Mild Renal Impairment)	0 of 8 (0%)	8 of 8 (100%)	Not reported
BI 201335 Relevant Treatment Dose (Moderate Renal Impairment)	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
BI 201335 Relevant Treatment Dose (Severe Renal Impairment)	0 of 8 (0%)	7 of 8 (87.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Hepatitis C

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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 201335 in people with Hepatitis C, 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 31 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 31 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?

AUC0-∞ (time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after 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 NCT01580306.

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 31 Jul 2015.