HealthyPhase 1NCT02253914
Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers
A Phase 1 study testing BILR 355 BS, solution, BILR 355 BS, tablet and Ritonavir in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose ritonavir in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BILR 355 BS, solution, BILR 355 BS, tablet and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Dec 2004
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males who meet the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- No finding deviating from normal (except as noted below) and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥18 years and <60
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Who cannot join
- Current and medically relevant 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
Show all 19Show fewer
- Intake of drugs with a long half-life (>24 hours) within one month prior to administration of study drug or 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 based on the knowledge at the time of protocol preparation
- Participation in another trial with an investigational drug within one month prior to administration or during the trial
- Smoker
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug 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 administration or during the trial)
- Any laboratory value outside the normal reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody positive)
- HIV-1 infected as defined by a positive HIV ELISA test
About this study
Official title: An Investigator Blinded, Randomized, Placebo-controlled Multiple Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers
Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose ritonavir in healthy male volunteers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILR 355 BS, solutionDrug
BILR 355 BS, tabletDrug
RitonavirDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BILR 355 BS, solution | Experimental | escalating doses Receives: Drug: BILR 355 BS, solution; Drug: Ritonavir |
| BILR 355 BS, tablet | Experimental | escalating doses Receives: Drug: BILR 355 BS, tablet; Drug: Ritonavir |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ (area under the concentration time curve of BILR 355 in plasma over one dosing interval at steady state)
Measured: up to day 11
Cmax (maximum concentration of BILR 355 in plasma)
Measured: up to day 11
Time for BILR 355 BS to achieve steady state
Measured: up to day 11
Cmin,ss (trough concentration of BILR 355 BS in plasma at steady state)
Measured: up to day 11
Incidence of dose limiting toxicity
Measured: up to day 21
Secondary outcomes (6)
tmax (time from dosing to the maximum concentration of BILR 355 in plasma)
Measured: up to day 11
AUCτ (area under the concentration time curve of metabolite 402 in plasma over one dosing interval at steady state)
Measured: up to day 11
Cmax (maximum concentration of metabolite 402 in plasma)
Measured: up to day 11
Ae (amount of BILR 355 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)
Measured: up to day 11
Metabolite BILR 402 Ae (amount of BILR 402 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)
Measured: up to day 11
Number of subjects with adverse events
Measured: up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startFeb 2004
- Primary completionDec 2004
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
- Double blind
- Enrolment
- 100 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
- NCT02253914
- Sponsor's protocol ID
- 1188.2
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Blinded, Randomized, Placebo-controlled Multiple Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers
- ClinicalTrials.gov ID
- NCT02253914
- Acronym / sponsor ID
- 1188.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Dec 2004 (actual)
- First posted
- 1 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 safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose ritonavir in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BILR 355 BS, solution | Experimental | Drug: BILR 355 BS, solution, Drug: Ritonavirescalating doses |
| BILR 355 BS, tablet | Experimental | Drug: BILR 355 BS, tablet, Drug: Ritonavirescalating doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males who meet the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥18 years and <60
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Key exclusion criteria (19 listed)
- Current and medically relevant 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, solution | Drug | BILR 355 BS, solution |
| BILR 355 BS, tablet | Drug | BILR 355 BS, tablet |
| Ritonavir | Drug | BILR 355 BS, solution, BILR 355 BS, tablet |
| Placebo | Drug | Placebo |
Primary outcome
AUCτ (area under the concentration time curve of BILR 355 in plasma over one dosing interval at steady state)
Time frame: up to day 11
Cmax (maximum concentration of BILR 355 in plasma)
Time frame: up to day 11
Time for BILR 355 BS to achieve steady state
Time frame: up to day 11
Cmin,ss (trough concentration of BILR 355 BS in plasma at steady state)
Time frame: up to day 11
Incidence of dose limiting toxicity
Time frame: up to day 21
6 secondary outcomes
tmax (time from dosing to the maximum concentration of BILR 355 in plasma)
Time frame: up to day 11
AUCτ (area under the concentration time curve of metabolite 402 in plasma over one dosing interval at steady state)
Time frame: up to day 11
Cmax (maximum concentration of metabolite 402 in plasma)
Time frame: up to day 11
Ae (amount of BILR 355 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)
Time frame: up to day 11
Metabolite BILR 402 Ae (amount of BILR 402 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)
Time frame: up to day 11
Number of subjects with adverse events
Time frame: up to 42 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 1 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, solution, BILR 355 BS, tablet 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 7 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 1 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. Some participants in this study may receive a placebo. 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?
AUCτ (area under the concentration time curve of BILR 355 in plasma over one dosing interval at steady state) (time frame: up to day 11). The study lists 5 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 1 Oct 2014.