HealthyPhase 1NCT02257008
Effect of Different Boosting Agents on Pharmacokinetics of BILR 355 BS Dissolved in Polyethylene Glycol 400 (PEG 400) in Healthy Male Volunteers
A Phase 1 study testing BILR 355 BS, Grapefruit juice and Nelfinavir in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Assessment of the effect of different boosting agents on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400 Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BILR 355 BS, Grapefruit juice and Nelfinavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Dec 2003
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants in the study were to be healthy males, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)
- In accordance with good clinical practice (GCP) and the local legislation all volunteers had to give their written informed consent prior to admission to the study
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of 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
Show all 19Show fewer
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- Participation in another trial with an investigational drug (<= two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (>= 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the clinically accepted reference range
- Excessive physical activities within the last week before the trial or during the trial
- Following exclusion criteria are of special interest for this study:
- Erythema, exanthema and comparable skin alterations
- For the boosting agents atazanavir and atazanavir plus ritonavir, subjects with a PQ interval length in the screening ECG of > 200 ms or any higher degree of atrio-ventricular (AV) block were to be excluded
About this study
Official title: An Open Study to Investigate the Effect of Different Boosting Agents on Pharmacokinetics of Single Doses of BILR 355 BS (Dose Steps: 5 and 12.5 mg) Dissolved in 5 mL PEG 400 After Oral Administration in Healthy Male Volunteers
Assessment of the effect of different boosting agents on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILR 355 BSDrug
Grapefruit juiceOther
NelfinavirDrug
AtazanavirDrug
RitonavirDrug
| Study group | Role | What they receive |
|---|---|---|
| Single rising dose of BILR 355 BS with grapefruit juice | Experimental | Not described Receives: Drug: BILR 355 BS; Other: Grapefruit juice |
| Single rising dose of BILR 355 BS with nelfinavir | Experimental | Not described Receives: Drug: BILR 355 BS; Drug: Nelfinavir |
| Single dose of BILR 355 BS with atazanavir | Experimental | Not described Receives: Drug: BILR 355 BS; Drug: Atazanavir |
| Single dose of BILR 355 BS with atazanavir, ritonavir | Experimental | Not described Receives: Drug: BILR 355 BS; Drug: Atazanavir; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration of the analyte in the plasma (Cmax)
Measured: up to 120 hours after start of treatment
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: up to 120 hours after start of treatment
Area under the concentration-time curve of the analyte in plasma at different time points (AUC)
Measured: up to 120 hours after start of treatment
Apparent terminal half-life of the analyte in plasma (t1/2)
Measured: up to 120 hours after start of treatment
Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/F)
Measured: up to 120 hours after start of treatment
Total mean residence time of the analyte in the body (MRTtot)
Measured: up to 120 hours after start of treatment
Apparent volume of distribution of the analyte during the terminal phase λz following extravascular administration (Vz/F)
Measured: up to 120 hours after start of treatment
Renal clearance of the analyte determined over the dosing interval τ (CLR)
Measured: up to 120 hours after start of treatment
Amount of the analyte excreted into urine (Ae)
Measured: up to 72 hours after start of treatment
Secondary outcomes (7)
Number of participants with clinically relevant changes in laboratory parameters
Measured: up to 10 days after start of treatment
Number of participants with clinically relevant changes in vital signs (blood pressure, pulse-, respiratory rate, body temperature)
Measured: up to 10 days after start of treatment
Number of participants with clinically relevant changes in 12-lead ECG
Measured: up to 10 days after start of treatment
Number of participants with clinically relevant changes in faecal occult blood testing
Measured: up to 10 days after start of treatment
Number of participants with adverse events
Measured: Up to 25 days
Global tolerability assessment by investigator on a 5-point scale
Measured: Up to 10 days after start of treatment
Number of participants with clinically relevant changes in neurological assessment
Assessment of central nervous system function including Romberg's test, heel-to-toe straight line, and finger-nose tests
Measured: up to 10 days after start of treatment
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 startMar 2003
- Primary completionDec 2003
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
- 44 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
- NCT02257008
- Sponsor's protocol ID
- 1188.6
- 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
- An Open Study to Investigate the Effect of Different Boosting Agents on Pharmacokinetics of Single Doses of BILR 355 BS (Dose Steps: 5 and 12.5 mg) Dissolved in 5 mL PEG 400 After Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02257008
- Acronym / sponsor ID
- 1188.6
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Dec 2003 (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.
Assessment of the effect of different boosting agents on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single rising dose of BILR 355 BS with grapefruit juice | Experimental | Drug: BILR 355 BS, Other: Grapefruit juice |
| Single rising dose of BILR 355 BS with nelfinavir | Experimental | Drug: BILR 355 BS, Drug: Nelfinavir |
| Single dose of BILR 355 BS with atazanavir | Experimental | Drug: BILR 355 BS, Drug: Atazanavir |
| Single dose of BILR 355 BS with atazanavir, ritonavir | Experimental | Drug: BILR 355 BS, Drug: Atazanavir, Drug: Ritonavir |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All participants in the study were to be healthy males, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)
- In accordance with good clinical practice (GCP) and the local legislation all volunteers had to give their written informed consent prior to admission to the study
Key exclusion criteria (19 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of 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 | Drug | Single dose of BILR 355 BS with atazanavir, Single dose of BILR 355 BS with atazanavir, ritonavir, Single rising dose of BILR 355 BS with grapefruit juice, Single rising dose of BILR 355 BS with nelfinavir |
| Grapefruit juice | Other | Single rising dose of BILR 355 BS with grapefruit juice |
| Nelfinavir | Drug | Single rising dose of BILR 355 BS with nelfinavir |
| Atazanavir | Drug | Single dose of BILR 355 BS with atazanavir, Single dose of BILR 355 BS with atazanavir, ritonavir |
| Ritonavir | Drug | Single dose of BILR 355 BS with atazanavir, ritonavir |
Primary outcome
Maximum observed concentration of the analyte in the plasma (Cmax)
Time frame: up to 120 hours after start of treatment
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 120 hours after start of treatment
Area under the concentration-time curve of the analyte in plasma at different time points (AUC)
Time frame: up to 120 hours after start of treatment
Apparent terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 120 hours after start of treatment
Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/F)
Time frame: up to 120 hours after start of treatment
Total mean residence time of the analyte in the body (MRTtot)
Time frame: up to 120 hours after start of treatment
Apparent volume of distribution of the analyte during the terminal phase λz following extravascular administration (Vz/F)
Time frame: up to 120 hours after start of treatment
Renal clearance of the analyte determined over the dosing interval τ (CLR)
Time frame: up to 120 hours after start of treatment
Amount of the analyte excreted into urine (Ae)
Time frame: up to 72 hours after start of treatment
7 secondary outcomes
Number of participants with clinically relevant changes in laboratory parameters
Time frame: up to 10 days after start of treatment
Number of participants with clinically relevant changes in vital signs (blood pressure, pulse-, respiratory rate, body temperature)
Time frame: up to 10 days after start of treatment
Number of participants with clinically relevant changes in 12-lead ECG
Time frame: up to 10 days after start of treatment
Number of participants with clinically relevant changes in faecal occult blood testing
Time frame: up to 10 days after start of treatment
Number of participants with adverse events
Time frame: Up to 25 days
Global tolerability assessment by investigator on a 5-point scale
Time frame: Up to 10 days after start of treatment
Number of participants with clinically relevant changes in neurological assessment
Time frame: up to 10 days after start of treatment
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, Grapefruit juice and Nelfinavir 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 2 inclusion and 19 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?
Maximum observed concentration of the analyte in the plasma (Cmax) (time frame: up to 120 hours after start of treatment). The study lists 9 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.