HIV InfectionsPhase 1NCT01374802

Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

A Phase 1 study testing Darunavir, Ritonavir and BI 201335 in people with HIV Infections, 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 objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Darunavir, Ritonavir and BI 201335
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteGermany
Study dates: Jun 2011to Jul 2011
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects according to the following criteria: medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age 18 to 55 years (incl.)
Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) and weight greater than 50 kg
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Who cannot join

Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
History of photosensitivity or recurrent rash.
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

Show all 21Show 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)
Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug 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
Smoker (more than 10 cigarettes)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 30 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
ALT outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Positive serology tests for Human immunodeficiency virus (HIV) and hepatitis B / C virus
Vulnerable subjects (e.g. persons kept in detention)

Trial locations and contacts

1 site in 1 country.

Germany1 site

1220.49.1 Boehringer Ingelheim Investigational Site
Berlin

Other trials in Germany

About this study

Official title: Effect of Multiple Dosing With 240 mg QD BI 201335 on the Steady-state Pharmacokinetics of 800 mg QD Darunavir Coadministered With 100 mg QD Ritonavir (DRV/r) in Healthy Male and Female Volunteers (an Open-label, Multiple-dose, Single Group, Single Fixed Sequence Phase I Study)

The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.

Conditions: HIV Infections
Being tested: Darunavir, Ritonavir, BI 201335
Medical subject headings: HIV Infections

What participants receive

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

DarunavirDrug
400 mg tablet for oral administration
RitonavirDrug
tablet for oral administration
BI 201335Drug

Study groups in NCT01374802
Study group	Role	What they receive
BI 201335	Experimental	capsule for oral administration Receives: Drug: BI 201335
Darunavir 400 mg	Experimental	tablet for oral administration Receives: Drug: Darunavir
Ritonavir 100 mg	Experimental	tablet for oral administration Receives: Drug: Ritonavir

What is being measured

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

AUCτ,ss of Darunavir
area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir.
The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
Cτ,ss of Darunavir
concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
Cmax,ss of Darunavir
maximum measured concentration of the analyte in plasma at steady-state
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)

Secondary outcomes (1)

Tmax,ss of Darunavir
time from last dosing to maximum concentration of the analyte in plasma at steady state
Measured: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)

Timeline

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

Jun 2011Jul 2011

First posted16 Jun 2011 (estimated)
Study startJun 2011
Primary completionJul 2011

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 HIV InfectionsStudies 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: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01374802
Sponsor's protocol ID: 1220.49
Other IDs: 2011-000505-41
Status last verified: Jul 2015
First submitted: 8 Jun 2011
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?

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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: Effect of Multiple Dosing With 240 mg QD BI 201335 on the Steady-state Pharmacokinetics of 800 mg QD Darunavir Coadministered With 100 mg QD Ritonavir (DRV/r) in Healthy Male and Female Volunteers (an Open-label, Multiple-dose, Single Group, Single Fixed Sequence Phase I Study)
ClinicalTrials.gov ID: NCT01374802
Acronym / sponsor ID: 1220.49
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Jul 2011 (actual)
First posted: 16 Jun 2011 (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 of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
BI 201335	Experimental	Drug: BI 201335capsule for oral administration
Darunavir 400 mg	Experimental	Drug: Darunavirtablet for oral administration
Ritonavir 100 mg	Experimental	Drug: Ritonavirtablet for oral administration

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male and female subjects according to the following criteria: medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age 18 to 55 years (incl.)
Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) and weight greater than 50 kg
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Key exclusion criteria (21 listed)

Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
History of photosensitivity or recurrent rash.
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
Darunavir400 mg tablet for oral administration	Drug	Darunavir 400 mg
Ritonavirtablet for oral administration	Drug	Ritonavir 100 mg
BI 201335	Drug	BI 201335

Primary outcome

AUCτ,ss of Darunavir
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities
Cτ,ss of Darunavir
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir
Cmax,ss of Darunavir
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)
maximum measured concentration of the analyte in plasma at steady-state

1 secondary outcome

Tmax,ss of Darunavir
Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)

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
All Subjects	14	14

Primary outcome: AUCτ,ss of Darunavir

Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r). Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Darunavir+Ritonavir n = 14	Faldaprevir+Darunavir+Ritonavir n = 14
Value	57200 (29.5)	66000 (39.9)

Darunavir+Ritonavir vs Faldaprevir+Darunavir+Ritonavir: Geometric Mean Ratio: 115.29 (90% CI 101.36 to 131.13), ANOVA

Population analysed: Pharmacokinetic (PK) set: all subjects in the treated set who provided at least one observation for at least one primary endpoint without any important protocol violations relevant to the pharmacokinetic evaluation and who did not experience vomiting at or before 2 times median tmax.

Primary outcome: Cτ,ss of Darunavir

Time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Darunavir+Ritonavir n = 14	Faldaprevir+Darunavir+Ritonavir n = 14
Value	1330 (49.5)	1170 (90.3)

Darunavir+Ritonavir vs Faldaprevir+Darunavir+Ritonavir: Geometric Mean Ratio: 87.91 (90% CI 68.609 to 112.630), ANOVA

Population analysed: PK set

Primary outcome: Cmax,ss of Darunavir

Measure	Darunavir+Ritonavir n = 14	Faldaprevir+Darunavir+Ritonavir n = 14
Value	4930 (23.9)	6330 (26.5)

Darunavir+Ritonavir vs Faldaprevir+Darunavir+Ritonavir: Geometric Mean Ratio: 128.41 (90% CI 115.724 to 142.489), ANOVA

Population analysed: PK set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) occurring up to 9 days after first drug administration of DRV/r were assigned to the treatment DRV/r and AEs occurring up to 13 days after last drug administration of DRV/r+FDV were assigned to the combined treatment DRV/r+FDV.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Darunavir+Ritonavir	0 of 14 (0%)	7 of 14 (50%)	Not reported
Faldaprevir+Darunavir+Ritonavir	0 of 14 (0%)	11 of 14 (78.6%)	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 Darunavir, Ritonavir and BI 201335 in people with HIV Infections, 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 4 inclusion and 21 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?

AUCτ,ss of Darunavir (time frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)). The study lists 3 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 NCT01374802.

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.