HealthyPhase 1NCT02256774
Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir in Healthy Subjects
A Phase 1 study testing BILR 355 BS, Combivir® and Ritonavir in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of Combivir® on BILR 355 BS pharmacokinetics. 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, Combivir® and Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to May 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 are not 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
- Body Mass Index (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 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)
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- 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 Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir
Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of Combivir® on BILR 355 BS pharmacokinetics.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILR 355 BSDrug
Combivir®Drug
RitonavirDrug
Also called NORVIR®
| Study group | Role | What they receive |
|---|---|---|
| Combivir® plus BILR 355/Ritonavir | Experimental | Not described Receives: Drug: BILR 355 BS; Drug: Combivir®; Drug: Ritonavir |
| BILR 355/Ritonavir | Experimental | Not described Receives: Drug: BILR 355 BS; Drug: Ritonavir |
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 at steady state (AUC0-12h,ss)
Measured: up to day 18
Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)
Measured: up to day 18
Secondary outcomes (8)
Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)
Measured: up to day 18
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Measured: up to day 18
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Measured: up to day 18
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/Fss)
Measured: up to day 18
Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h, ss)
Measured: up to day 18
Number of subjects with adverse events
Measured: up to 49 days
Number of subjects with abnormal laboratory parameters
Measured: up to 49 days
Number of subjects with clinically significant findings in vital signs
Measured: up to 49 days
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 startOct 2004
- Primary completionMay 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
- 51 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
- NCT02256774
- Sponsor's protocol ID
- 1188.9
- 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 Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir
- ClinicalTrials.gov ID
- NCT02256774
- Acronym / sponsor ID
- 1188.9
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- May 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.
Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of Combivir® on BILR 355 BS pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combivir® plus BILR 355/Ritonavir | Experimental | Drug: BILR 355 BS, Drug: Combivir®, Drug: Ritonavir |
| BILR 355/Ritonavir | Experimental | Drug: BILR 355 BS, Drug: Ritonavir |
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 are not 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
- Body Mass Index (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 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 | BILR 355/Ritonavir, Combivir® plus BILR 355/Ritonavir |
| Combivir® | Drug | Combivir® plus BILR 355/Ritonavir |
| RitonavirAlso: NORVIR® | Drug | BILR 355/Ritonavir, Combivir® plus BILR 355/Ritonavir |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over one dosing interval at steady state (AUC0-12h,ss)
Time frame: up to day 18
Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)
Time frame: up to day 18
8 secondary outcomes
Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)
Time frame: up to day 18
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: up to day 18
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time frame: up to day 18
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/Fss)
Time frame: up to day 18
Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h, ss)
Time frame: up to day 18
Number of subjects with adverse events
Time frame: up to 49 days
Number of subjects with abnormal laboratory parameters
Time frame: up to 49 days
Number of subjects with clinically significant findings in vital signs
Time frame: up to 49 days
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, Combivir® and Ritonavir 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 at steady state (AUC0-12h,ss) (time frame: up to day 18). 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.