HealthyPhase 1NCT02253927
Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers
A Phase 1 study testing BILR 355 - D1, BILR 355 - D2 and BILR 355 - D3 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BILR 355 - D1, BILR 355 - D2 and BILR 355 - D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Aug 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females who met the inclusion/exclusion criteria, females who are not pregnant nor nursing, and who agreed 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)
- Healthy HIV negative adult 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 is deemed relevant to the trial as judged by the investigator
Show all 18Show 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 is 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)
- Pregnant or lactating females
About this study
Official title: Phase I Sequential Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose (225 Mg-450 mg) Oral Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers
The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses.
A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355 (SDS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BILR 355 - D1Drug
BILR 355 - D2Drug
BILR 355 - D3Drug
BILR 355 - D4Drug
RitonavirDrug
high fat breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| BILR 355 (dose escalation) + Ritonavir | Experimental | escalating dose groups, for food effect evaluation lowest dose group (D1) with high fat meal breakfast after wash-out period Receives: Drug: BILR 355 - D1; Drug: BILR 355 - D2; Drug: BILR 355 - D3; Drug: BILR 355 - D4; Drug: Ritonavir; Other: high fat breakfast |
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 120 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 120 hours after drug administration
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Measured: up to 120 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Measured: up to 120 hours after drug administration
Tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 120 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 120 hours after drug administration
Secondary outcomes (1)
Number of patients with adverse events
Measured: up to 10 days after last dose 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 startMay 2006
- Primary completionAug 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT02253927
- Sponsor's protocol ID
- 1188.32
- 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
- Phase I Sequential Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose (225 Mg-450 mg) Oral Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02253927
- Acronym / sponsor ID
- 1188.32
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Aug 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.
The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses.
A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355 (SDS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BILR 355 (dose escalation) + Ritonavir | Experimental | Drug: BILR 355 - D1, Drug: BILR 355 - D2, Drug: BILR 355 - D3, Drug: BILR 355 - D4, Drug: Ritonavir, Other: high fat breakfastescalating dose groups, for food effect evaluation lowest dose group (D1) with high fat meal breakfast after wash-out period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females who met the inclusion/exclusion criteria, females who are not pregnant nor nursing, and who agreed 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)
- Healthy HIV negative adult 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 (18 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 - D1 | Drug | BILR 355 (dose escalation) + Ritonavir |
| BILR 355 - D2 | Drug | BILR 355 (dose escalation) + Ritonavir |
| BILR 355 - D3 | Drug | BILR 355 (dose escalation) + Ritonavir |
| BILR 355 - D4 | Drug | BILR 355 (dose escalation) + Ritonavir |
| Ritonavir | Drug | BILR 355 (dose escalation) + Ritonavir |
| high fat breakfast | Other | BILR 355 (dose escalation) + Ritonavir |
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 120 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 120 hours after drug administration
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 120 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 120 hours after drug administration
Tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 120 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 120 hours after drug administration
1 secondary outcome
Number of patients with adverse events
Time frame: up to 10 days after last dose 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 - D1, BILR 355 - D2 and BILR 355 - D3 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 5 inclusion and 18 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 120 hours after drug administration). The study lists 6 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.