Hepatitis CPhase 1NCT01704846

Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules

A Phase 1 study testing BI 201335 NA 120 mg capsule and BI 201335 NA 40 mg capsule in people with Hepatitis C, run by Boehringer Ingelheim at 1 site in Japan.

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 objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hepatitis C
What is being tested?: BI 201335 NA 120 mg capsule and BI 201335 NA 40 mg capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteJapan
Study dates: Oct 2012to Jan 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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male volunteers without any clinical significant findings and complications
Age: 20 - 45 years
BMI: 18.5 - 25.0 kg/m2
Signed informed consent

Who cannot join

Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
History of jaundice
Surgery of the gastrointestinal tract (except appendectomy).
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.

Show all 20Show fewer

History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections.
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement.
Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Use of drugs which might reasonably influence the results (pharmacokinetic) of the trial within at least 10 days prior to administration or during the trial.
Participation in another trial with an investigational drug within two months prior to administration or during the trial.
Smoking (>10 cigarettes or >3 cigars or >3 pipes/day).
Inability to refrain from smoking during the trial.
Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake).
Drug abuse.
Blood donation (more than 100 mL within four weeks prior to administration).
Excessive physical activities (within one week prior to administration).
Any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement.
Any history of relevant liver diseases (for instance, disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).

Trial locations and contacts

1 site in 1 country.

Japan1 site

1220.53.08101 Boehringer Ingelheim Investigational Site
Sumida-ku,Tokyo

Other trials in Japan

About this study

Official title: Assessment of Bioequivalence Between Two Different Formulations of BI 201335 NA Soft Gelatine Capsules in Healthy Male Volunteers. (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover Study)

The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.

Conditions: Hepatitis C
Being tested: BI 201335 NA 120 mg capsule, BI 201335 NA 40 mg capsule
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 201335 NA 120 mg capsuleDrug
1capsule of BI 201335 NA 120 mg capsule
BI 201335 NA 120 mg capsuleDrug
1 capsule of BI 201335 NA 120 mg capsule
BI 201335 NA 40 mg capsuleDrug
3 capsules of BI 201335 NA 40 mg capsule
BI 201335 NA 40 mg capsuleDrug
3 capsules of BI 201335 NA 40 mg capsule

Study groups in NCT01704846
Study group	Role	What they receive
Treatment sequence 1	Experimental	Test - Reference - Reference - Test Receives: Drug: BI 201335 NA 120 mg capsule; Drug: BI 201335 NA 40 mg capsule
Treatment sequence 2	Experimental	Reference - Test - Test - Reference Receives: Drug: BI 201335 NA 120 mg capsule; Drug: BI 201335 NA 40 mg capsule

What is being measured

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

Area Under the Curve of the Analyte From Time 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 time of the last quantifiable data point.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Measured: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Maximum Measured Concentration (Cmax)
Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Measured: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration

Secondary outcomes (5)

Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Measured: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Time From Dosing to the Maximum Measured Concentration (Tmax)
Time from dosing to the maximum measured concentration of the analyte in plasma.
Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation.
Measured: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Terminal Rate Constant (λz)
Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Measured: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Terminal Half-life (t1/2)
Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Measured: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Mean Residence Time (MRTpo)
Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Measured: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration

Timeline

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

Oct 2012Jan 2013

First posted12 Oct 2012 (estimated)
Study startOct 2012
Primary completionJan 2013
Study completionJan 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 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01704846
Sponsor's protocol ID: 1220.53
Status last verified: Jul 2015
First submitted: 9 Oct 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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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: Assessment of Bioequivalence Between Two Different Formulations of BI 201335 NA Soft Gelatine Capsules in Healthy Male Volunteers. (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover Study)
ClinicalTrials.gov ID: NCT01704846
Acronym / sponsor ID: 1220.53
Conditions: Hepatitis C
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 12 Oct 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.

The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.

Study design

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

Arm	Type	Receives
Treatment sequence 1	Experimental	Drug: BI 201335 NA 120 mg capsule, Drug: BI 201335 NA 40 mg capsuleTest - Reference - Reference - Test
Treatment sequence 2	Experimental	Drug: BI 201335 NA 120 mg capsule, Drug: BI 201335 NA 40 mg capsuleReference - Test - Test - Reference

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male volunteers without any clinical significant findings and complications
Age: 20 - 45 years
BMI: 18.5 - 25.0 kg/m2
Signed informed consent

Key exclusion criteria (20 listed)

Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
History of jaundice
Surgery of the gastrointestinal tract (except appendectomy).

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 201335 NA 120 mg capsule1capsule of BI 201335 NA 120 mg capsule	Drug	Treatment sequence 2
BI 201335 NA 120 mg capsule1 capsule of BI 201335 NA 120 mg capsule	Drug	Treatment sequence 1
BI 201335 NA 40 mg capsule3 capsules of BI 201335 NA 40 mg capsule	Drug	Treatment sequence 1
BI 201335 NA 40 mg capsule3 capsules of BI 201335 NA 40 mg capsule	Drug	Treatment sequence 2

Primary outcome

Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Maximum Measured Concentration (Cmax)
Time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.

5 secondary outcomes

Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Time From Dosing to the Maximum Measured Concentration (Tmax)
Time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Terminal Rate Constant (λz)
Time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Terminal Half-life (t1/2)
Time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Mean Residence Time (MRTpo)
Time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h 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
Treatment Sequence 1	30	30
Treatment Sequence 2	30	30

Primary outcome: Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng·h/mL

Measure	Test Product: Faldaprevir 40 mg x 3 Capsules n = 59	Reference Product: Faldaprevir 120 mg x 1 Capsule n = 60
Value	17297.157 (19.71)	17216.514 (23.89)

Test Product: Faldaprevir 40 mg x 3 Capsules vs Reference Product: Faldaprevir 120 mg x 1 Capsule: Adjusted Geometric Mean Ratio (%): 100.47 (90% CI 95.90 to 105.25)

Population analysed: Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.

Primary outcome: Maximum Measured Concentration (Cmax)

Measure	Test Product: Faldaprevir 40 mg x 3 Capsules n = 59	Reference Product: Faldaprevir 120 mg x 1 Capsule n = 60
Value	943.868 (32.16)	916.480 (39.22)

Test Product: Faldaprevir 40 mg x 3 Capsules vs Reference Product: Faldaprevir 120 mg x 1 Capsule: Adjusted Geometric Mean Ratio (%): 102.99 (90% CI 95.57 to 110.98)

Population analysed: Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Four treatment periods (Period 1 to 4) of 6 days for each (Days -1 to 5) + Washout period of at least 14 days between treatments. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product: Faldaprevir 40 mg x 3 Capsules	0 of 59 (0%)	7 of 59 (11.9%)	Not reported
Reference Product: Faldaprevir 120 mg x 1 Capsule	0 of 60 (0%)	8 of 60 (13.3%)	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.

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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 NA 120 mg capsule and BI 201335 NA 40 mg capsule in people with Hepatitis C, run by Boehringer Ingelheim at 1 site in Japan.

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 4 inclusion and 20 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 Japan. 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?

Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h 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 NCT01704846.

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.