HealthyPhase 1NCT02259868

Study of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects

A Phase 1 study testing BILR 355 BS /1B, current low dose formulation, BILR 355 BS /1B, current high dose formulation and BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation in people with Healthy, run by Boehringer Ingelheim.

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

1. To investigate the relative bioavailability (BA) of improved tablet formulation candidates to determine which formulation will be developed for use in late Phase II and Phase III clinical trials 2. To investigate the relative BA of the pediatric suspension, compared to the current 1B formulation 3. Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BILR 355 BS /1B, current low dose formulation, BILR 355 BS /1B, current high dose formulation and BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: No sites listed yet
Study dates: Jun 2005to Sep 2005
Phase: Phase 1
Are there results?: None posted in the registry

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 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy HIV negative adult male volunteers
Age ≥18 and ≤ 60 years
BMI ≥18.5 and BMI ≤29.9 kg/m2
Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations

Who cannot join

Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator

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Intake of drugs with a long half-life (>24 hours) within at least one month prior to study drug administration and during the trial
Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Current smoker
Alcohol abuse (more than 60 g/day)
Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse).
Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
Excessive physical activities (within one week prior to study drug administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgment of the investigator
Inability to comply with dietary regimen required by the protocol
Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive

About this study

Official title: Randomized Single Dose Multiple Crossover Relative Bioavailability Trial of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects

To investigate the relative bioavailability (BA) of improved tablet formulation candidates to determine which formulation will be developed for use in late Phase II and Phase III clinical trials
To investigate the relative BA of the pediatric suspension, compared to the current 1B formulation
To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three 25mg tablets vs. one 75 mg tablet, current 1B formulation

Conditions: Healthy
Being tested: BILR 355 BS /1B, current low dose formulation, BILR 355 BS /1B, current high dose formulation, BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation, BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation, BILR 355 BS - Suspension low dose

What participants receive

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

BILR 355 BS /1B, current low dose formulationDrug
BILR 355 BS /1B, current high dose formulationDrug
BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulationDrug
BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulationDrug
BILR 355 BS - Suspension low doseDrug
BILR 355 BS - Suspension high doseDrug
RitonavirDrug

Study groups in NCT02259868
Study group	Role	What they receive
Group A	Experimental	randomized sequence of current low dose formulation (3 tablets) and high dose (1 tablet) BILR 355 BS 1B formulation, separated by 14-day washout Receives: Drug: BILR 355 BS /1B, current low dose formulation; Drug: BILR 355 BS /1B, current high dose formulation; Drug: Ritonavir
Group B	Experimental	randomized sequence of BILR 355 BS (JM) + SDS formulation low dose (2 tablets) ,BILR 355 BS (HM) + SDS formulation low dose (2 tablets), BILR 355 BS high dose 1B formulation (4 low dose tablets), separated by 14-day washout Receives: Drug: BILR 355 BS /1B, current low dose formulation; Drug: BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation; Drug: BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation; Drug: Ritonavir
Group C	Experimental	randomized sequence of BILR 355 BS (JM) + SDS formulation high dose (4 tablets) , BILR 355 BS (JM) + SDS formulation mid dose (3 tablets), BILR 355 BS (HM) + SDS formulation high dose (4 tablets), separated by 14-day washout Receives: Drug: BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation; Drug: BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation; Drug: Ritonavir
Group D	Experimental	randomized sequence of BILR 355 BS Suspension high dose, BILR 355 BS Suspension low dose, current low dose BILR 355 BS 1B formulation (3 tablets) separated by 14-day washout Receives: Drug: BILR 355 BS /1B, current low dose formulation; Drug: BILR 355 BS - Suspension low dose; Drug: BILR 355 BS - Suspension high dose; Drug: Ritonavir

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 the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Up to 96 hours after drug administration
Cmax (maximum measured concentration of analyte in plasma)
Measured: Up to 96 hours after drug administration

Secondary outcomes (10)

AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: Up to 96 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: Up to 96 hours after drug administration
λz (terminal rate constant in plasma)
Measured: Up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: Up to 96 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Measured: Up to 96 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: Up to 96 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: Up to 96 hours after drug administration
Number of participants with clinically significant changes in vital signs
Measured: Up to day 43 after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Measured: Up to day 43 after first drug administration
Number of participants with Adverse Events
Measured: Up to day 43 after first drug administration

Timeline

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

Jun 2005Sep 2005

First posted9 Oct 2014 (estimated)
Study startJun 2005
Primary completionSep 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02259868
Sponsor's protocol ID: 1188.5
Status last verified: Aug 2018
First submitted: 7 Oct 2014
Last updated: 31 Aug 2018
Results posted: No

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Single Dose Multiple Crossover Relative Bioavailability Trial of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects
ClinicalTrials.gov ID: NCT02259868
Acronym / sponsor ID: 1188.5
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: Sep 2005 (actual)
First posted: 9 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate the relative bioavailability (BA) of improved tablet formulation candidates to determine which formulation will be developed for use in late Phase II and Phase III clinical trials
To investigate the relative BA of the pediatric suspension, compared to the current 1B formulation
To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three 25mg tablets vs. one 75 mg tablet, current 1B formulation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group A	Experimental	Drug: BILR 355 BS /1B, current low dose formulation, Drug: BILR 355 BS /1B, current high dose formulation, Drug: Ritonavirrandomized sequence of current low dose formulation (3 tablets) and high dose (1 tablet) BILR 355 BS 1B formulation, separated by 14-day washout
Group B	Experimental	Drug: BILR 355 BS /1B, current low dose formulation, Drug: BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation, Drug: BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation, Drug: Ritonavirrandomized sequence of BILR 355 BS (JM) + SDS formulation low dose (2 tablets) ,BILR 355 BS (HM) + SDS formulation low dose (2 tablets), BILR 355 BS high dose 1B formulation (4 low dose tablets), separated by 14-day washout
Group C	Experimental	Drug: BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation, Drug: BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation, Drug: Ritonavirrandomized sequence of BILR 355 BS (JM) + SDS formulation high dose (4 tablets) , BILR 355 BS (JM) + SDS formulation mid dose (3 tablets), BILR 355 BS (HM) + SDS formulation high dose (4 tablets), separated by 14-day washout
Group D	Experimental	Drug: BILR 355 BS /1B, current low dose formulation, Drug: BILR 355 BS - Suspension low dose, Drug: BILR 355 BS - Suspension high dose, Drug: Ritonavirrandomized sequence of BILR 355 BS Suspension high dose, BILR 355 BS Suspension low dose, current low dose BILR 355 BS 1B formulation (3 tablets) separated by 14-day washout

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy HIV negative adult male volunteers
Age ≥18 and ≤ 60 years
BMI ≥18.5 and BMI ≤29.9 kg/m2
Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations

Key exclusion criteria (17 listed)

Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections

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
BILR 355 BS /1B, current low dose formulation	Drug	Group A, Group B, Group D
BILR 355 BS /1B, current high dose formulation	Drug	Group A
BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation	Drug	Group B, Group C
BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation	Drug	Group B, Group C
BILR 355 BS - Suspension low dose	Drug	Group D
BILR 355 BS - Suspension high dose	Drug	Group D
Ritonavir	Drug	Group A, Group B, Group C, Group D

Primary outcome

AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 96 hours after drug administration
Cmax (maximum measured concentration of analyte in plasma)
Time frame: Up to 96 hours after drug administration

10 secondary outcomes

AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: Up to 96 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: Up to 96 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 96 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: Up to 96 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Up to 96 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Up to 96 hours after drug administration
Number of participants with clinically significant changes in vital signs
Time frame: Up to day 43 after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to day 43 after first drug administration
Number of participants with Adverse Events
Time frame: Up to day 43 after first drug administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 17 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: Up to 96 hours 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 NCT02259868.

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 Aug 2018.