HealthyPhase 1NCT02253940
Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers
A Phase 1 study testing BILR 355 - Treatment A (current tablet formulation), BILR 355 - Treatment B (new tablet formulation) and BILR 355 - Treatment C (new capsule formulation) in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the single dose, relative BA of new SDS-containing formulations of BILR 355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet formulation (50 mg tablet) 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 - Treatment A (current tablet formulation), BILR 355 - Treatment B (new tablet formulation) and BILR 355 - Treatment C (new capsule formulation)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Dec 2006
- 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 was deemed relevant to the trial as judged by the investigator
Show all 17Show fewer
- 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 was 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: An Open-label, Randomized, Crossover Relative BA Study of Pharmacokinetics and Safety of New SDS-containing Tablet and Capsule Formulations of BILR 355 Compared to the Current Formulation (50 mg Tablet), After Single Dose Oral Administration of BILR 355 Plus Low Dose Ritonavir in Healthy Male Volunteers
Study to determine the single dose, relative BA of new SDS-containing formulations of BILR 355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet formulation (50 mg tablet)
- Conditions
- Healthy
- Being tested
- BILR 355 - Treatment A (current tablet formulation), BILR 355 - Treatment B (new tablet formulation), BILR 355 - Treatment C (new capsule formulation), BILR 355 - Treatment D (current tablet formulation), BILR 355 - Treatment E (new capsule formulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILR 355 - Treatment A (current tablet formulation)Drug
BILR 355 - Treatment B (new tablet formulation)Drug
BILR 355 - Treatment C (new capsule formulation)Drug
BILR 355 - Treatment D (current tablet formulation)Drug
BILR 355 - Treatment E (new capsule formulation)Drug
RitonavirDrug
| Study group | Role | What they receive |
|---|---|---|
| Dose Group 1 - low dose | Experimental | Treatment sequences ABC / CAB / BCA Receives: Drug: BILR 355 - Treatment A (current tablet formulation); Drug: BILR 355 - Treatment B (new tablet formulation); Drug: BILR 355 - Treatment C (new capsule formulation); Drug: Ritonavir |
| Dose Group 2 - high dose | Experimental | Treatment sequences DE / ED Receives: Drug: BILR 355 - Treatment D (current tablet formulation); Drug: BILR 355 - Treatment E (new capsule formulation); Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf (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 (6)
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
t1/2 (terminal half-life of the analyte in plasma)
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
Number of subjects with adverse events
Measured: up to 12 days following last drug administration
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 48 hours after drug administration
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 startOct 2006
- Primary completionDec 2006
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
- 40 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
- NCT02253940
- Sponsor's protocol ID
- 1188.33
- 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 Open-label, Randomized, Crossover Relative BA Study of Pharmacokinetics and Safety of New SDS-containing Tablet and Capsule Formulations of BILR 355 Compared to the Current Formulation (50 mg Tablet), After Single Dose Oral Administration of BILR 355 Plus Low Dose Ritonavir in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02253940
- Acronym / sponsor ID
- 1188.33
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2006 (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 single dose, relative BA of new SDS-containing formulations of BILR 355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet formulation (50 mg tablet)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Group 1 - low dose | Experimental | Drug: BILR 355 - Treatment A (current tablet formulation), Drug: BILR 355 - Treatment B (new tablet formulation), Drug: BILR 355 - Treatment C (new capsule formulation), Drug: RitonavirTreatment sequences ABC / CAB / BCA |
| Dose Group 2 - high dose | Experimental | Drug: BILR 355 - Treatment D (current tablet formulation), Drug: BILR 355 - Treatment E (new capsule formulation), Drug: RitonavirTreatment sequences DE / ED |
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 - Treatment A (current tablet formulation) | Drug | Dose Group 1 - low dose |
| BILR 355 - Treatment B (new tablet formulation) | Drug | Dose Group 1 - low dose |
| BILR 355 - Treatment C (new capsule formulation) | Drug | Dose Group 1 - low dose |
| BILR 355 - Treatment D (current tablet formulation) | Drug | Dose Group 2 - high dose |
| BILR 355 - Treatment E (new capsule formulation) | Drug | Dose Group 2 - high dose |
| Ritonavir | Drug | Dose Group 1 - low dose, Dose Group 2 - high dose |
Primary outcome
AUC0-inf (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
6 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
t1/2 (terminal half-life of the analyte in plasma)
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
Number of subjects with adverse events
Time frame: up to 12 days following last drug administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 48 hours after 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 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 - Treatment A (current tablet formulation), BILR 355 - Treatment B (new tablet formulation) and BILR 355 - Treatment C (new capsule formulation) 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 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. 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-inf (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?
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.