HealthyPhase 1NCT02256826
Study of Pharmacokinetic Interaction Between Kaletra® (LPV/r) and BILR 355 BS Plus Ritonavir in Healthy Subjects
A Phase 1 study testing BILR 355 BS, Ritonavir (RTV) and Kaletra® in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BILR 355 BS, Ritonavir (RTV) and Kaletra®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jun 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females who meet the inclusion/exclusion criteria; females must not be pregnant or nursing, and agree to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives)
- 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
- Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Currently active (symptomatic within the last 30 days) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (>24 hours) within one month prior to administration of study drug or during the trial (review with clinical monitor if questionable)
Show all 17Show fewer
- Use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation (review with clinical monitor if questionable)
- Participation in another trial with an investigational drug within one month prior to administration or during the trial
- Current smoker
- Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
- Recent blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- Excessive physical activities (within 1 week prior to study drug administration or during the trial)
- Any laboratory value outside the normal 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
- Chronic or relevant acute infections
- Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
- HIV-1 infected as defined by a positive HIV ELISA test
About this study
Official title: Study of Pharmacokinetic Interaction Between Kaletra® (LPV/r) and BILR 355 BS Plus Ritonavir
To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS
- Conditions
- Healthy
- Being tested
- BILR 355 BS, Ritonavir (RTV), Kaletra®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILR 355 BSDrug
Ritonavir (RTV)Drug
NORVIR®
Kaletra®Drug
(lopinavir (LPV) and ritonavir (RTV))
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: BILR 355 BS; Drug: Ritonavir (RTV); Drug: Kaletra® |
| Group B | Experimental | Not described Receives: Drug: BILR 355 BS; Drug: Ritonavir (RTV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)
Measured: Up to 12 h after the last drug administration of BILR 355
Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)
Measured: Up to 96 h after the last drug administration of BILR 355
Secondary outcomes (11)
Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)
Measured: Up to 96 h after the last drug administration of BILR 355
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Measured: Up to 96 h after the last drug administration of BILR 355
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Measured: Up to 96 h after the last drug administration of BILR 355
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)
Measured: Up to 96 h after the last drug administration of BILR 355
Area under the plasma concentration time curve (0-12 hours) (AUC0-12h) for RTV
Measured: Up to 12 h after RTV administration
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for RTV
Measured: Up to 96 h after the last drug administration of BILR 355
Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h,ss)
Measured: Up to 12 h after the last drug administration of BILR 355
Number of participants with Adverse Events
Measured: Up to day 35 after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Measured: Up to day 35 after first drug administration
Number of participants with abnormal findings in physical examination
Measured: Up to day 35 after first drug administration
Number of participants with clinically significant changes in vital signs
Measured: Up to day 35 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.
- First posted6 Oct 2014 (estimated)
- Study startApr 2005
- Primary completionJun 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256826
- Sponsor's protocol ID
- 1188.8
- Status last verified
- Oct 2014
- First submitted
- 2 Oct 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pharmacokinetic Interaction Between Kaletra® (LPV/r) and BILR 355 BS Plus Ritonavir
- ClinicalTrials.gov ID
- NCT02256826
- Acronym / sponsor ID
- 1188.8
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2005 (actual)
- First posted
- 6 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 determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: BILR 355 BS, Drug: Ritonavir (RTV), Drug: Kaletra® |
| Group B | Experimental | Drug: BILR 355 BS, Drug: Ritonavir (RTV) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males or females who meet the inclusion/exclusion criteria; females must not be pregnant or nursing, and agree to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives)
- 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)
- Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Currently active (symptomatic within the last 30 days) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
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 | Drug | Group A, Group B |
| Ritonavir (RTV)NORVIR® | Drug | Group A, Group B |
| Kaletra®(lopinavir (LPV) and ritonavir (RTV)) | Drug | Group A |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)
Time frame: Up to 12 h after the last drug administration of BILR 355
Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
11 secondary outcomes
Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)
Time frame: Up to 96 h after the last drug administration of BILR 355
Area under the plasma concentration time curve (0-12 hours) (AUC0-12h) for RTV
Time frame: Up to 12 h after RTV administration
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for RTV
Time frame: Up to 96 h after the last drug administration of BILR 355
Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h,ss)
Time frame: Up to 12 h after the last drug administration of BILR 355
Number of participants with Adverse Events
Time frame: Up to day 35 after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to day 35 after first drug administration
Number of participants with abnormal findings in physical examination
Time frame: Up to day 35 after first drug administration
Number of participants with clinically significant changes in vital signs
Time frame: Up to day 35 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 6 Oct 2014.
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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?
A Phase 1 study testing BILR 355 BS, Ritonavir (RTV) and Kaletra® in people with Healthy, run by Boehringer Ingelheim.
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 6 Oct 2014. 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?
Area under the concentration-time curve of the analyte in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss) (time frame: Up to 12 h after the last drug administration of BILR 355). 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?
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 6 Oct 2014.