HealthyPhase 1NCT02182362
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 201335 NA in Healthy Male Subjects
A Phase 1 study testing BI 201335 NA in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The main objective was to investigate the safety, tolerability and the pharmacokinetics (PK) of BI 201335 NA in healthy male subjects without Gilbert's syndrome or polymorphism (GS) following oral administration of a single dose (Day 1) and repeated doses (Days 4-24) of 20 mg, 48 mg, 120 mg, and 240 mg. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 201335 NA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Feb 2008
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males according to the following criteria:
- Complete medical history, physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead ECG (electrocardiogram), and clinical laboratory tests
- Age ≥18 and Age ≤55 years
- BMI ≥18.5 and BMI ≤30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with polymorphisms associated with Gilbert's syndrome will be excluded from the initial 4 groups of the multiple rising dose phase of the study. However, only subjects with Gilbert's polymorphism will be allowed to participate in the last group which will be treated with the highest tolerated dose determined in the multiple rising dose phase of the trial
- Prior history of jaundice for subjects without Gilbert's polymorphism
- Surgery of the gastrointestinal tract (except appendectomy)
Show all 23Show fewer
- 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 30 days prior to screening until trial completion
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoking (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking during the trial
- Alcohol abuse (more than 60 g/day)
- Inability to refrain from alcohol during the trial
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for TdP (Torsades de points) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of 20 mg, 48 mg, 120 mg, and 240 mg Once a Day of BI 201335 NA (Oral Solution) in Healthy Male Subjects, in a Randomized Double Blind, Placebo Controlled Study
The main objective was to investigate the safety, tolerability and the pharmacokinetics (PK) of BI 201335 NA in healthy male subjects without Gilbert's syndrome or polymorphism (GS) following oral administration of a single dose (Day 1) and repeated doses (Days 4-24) of 20 mg, 48 mg, 120 mg, and 240 mg. Additionally, the safety, tolerability, and the PK of the highest tolerated dose of BI 201335 NA (determined during the multiple-rising-dose phase) were assessed in healthy male subjects with GS over a 28-day continuous drug administration period.
- Conditions
- Healthy
- Being tested
- BI 201335 NA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 201335 NADrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 201335 NA in rising doses | Experimental | single dose of BI 201335 NA on day 1, multiple dosing days 4-24 Receives: Drug: BI 201335 NA |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BI 201335 NA | Experimental | highest tolerated dose of BI 201335 on day 1-28 in patients with Gilbert's syndrome Receives: Drug: BI 201335 NA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with abnormal findings in physical examination
Measured: Baseline and up to 46 days
Number of patients with clinically relevant changes in vital signs (blood pressure (BP), pulse rate (PR))
Measured: Baseline and up to 32 days
Number of patients with clinically relevant changes in 12-lead ECG (electrocardiogram)
Measured: Baseline and up to 32 days
Number of patients with clinically relevant changes in clinical laboratory tests (haematology, clinical chemistry, urinalysis)
Measured: Baseline and up to 32 days
Incidence of adverse events
Measured: up to day 46
Assessment of tolerability by investigator
Measured: Day 28 or 32
Secondary outcomes (18)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
λz (terminal rate constant in plasma)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
t1/2 (terminal half-life of the analyte in plasma)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
MRTpo (mean residence time of the analyte in the body after single oral administration)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
CL/F (apparent clearance of the analyte in plasma)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
Vz/F (apparent volume of distribution during the terminal phase λz)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
λz,ss (terminal rate constant in plasma at steady state)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following multiple oral dose administration)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration)
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
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
- 39 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
- NCT02182362
- Sponsor's protocol ID
- 1220.6
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of 20 mg, 48 mg, 120 mg, and 240 mg Once a Day of BI 201335 NA (Oral Solution) in Healthy Male Subjects, in a Randomized Double Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02182362
- Acronym / sponsor ID
- 1220.6
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- First posted
- 8 Jul 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 main objective was to investigate the safety, tolerability and the pharmacokinetics (PK) of BI 201335 NA in healthy male subjects without Gilbert's syndrome or polymorphism (GS) following oral administration of a single dose (Day 1) and repeated doses (Days 4-24) of 20 mg, 48 mg, 120 mg, and 240 mg. Additionally, the safety, tolerability, and the PK of the highest tolerated dose of BI 201335 NA (determined during the multiple-rising-dose phase) were assessed in healthy male subjects with GS over a 28-day continuous drug administration period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 201335 NA in rising doses | Experimental | Drug: BI 201335 NAsingle dose of BI 201335 NA on day 1, multiple dosing days 4-24 |
| Placebo | Placebo comparator | Drug: Placebo |
| BI 201335 NA | Experimental | Drug: BI 201335 NAhighest tolerated dose of BI 201335 on day 1-28 in patients with Gilbert's syndrome |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males according to the following criteria:
- Age ≥18 and Age ≤55 years
- BMI ≥18.5 and BMI ≤30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Key exclusion criteria (23 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with polymorphisms associated with Gilbert's syndrome will be excluded from the initial 4 groups of the multiple rising dose phase of the study. However, only subjects with Gilbert's polymorphism will be allowed to participate in the last group which will be treated with the highest tolerated dose determined in the multiple rising dose phase of the trial
- Prior history of jaundice for subjects without Gilbert's polymorphism
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 |
|---|---|---|
| BI 201335 NA | Drug | BI 201335 NA, BI 201335 NA in rising doses |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with abnormal findings in physical examination
Time frame: Baseline and up to 46 days
Number of patients with clinically relevant changes in vital signs (blood pressure (BP), pulse rate (PR))
Time frame: Baseline and up to 32 days
Number of patients with clinically relevant changes in 12-lead ECG (electrocardiogram)
Time frame: Baseline and up to 32 days
Number of patients with clinically relevant changes in clinical laboratory tests (haematology, clinical chemistry, urinalysis)
Time frame: Baseline and up to 32 days
Incidence of adverse events
Time frame: up to day 46
Assessment of tolerability by investigator
Time frame: Day 28 or 32
18 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
λz (terminal rate constant in plasma)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
MRTpo (mean residence time of the analyte in the body after single oral administration)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
CL/F (apparent clearance of the analyte in plasma)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
Vz/F (apparent volume of distribution during the terminal phase λz)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60 hours after first treatment
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
λz,ss (terminal rate constant in plasma at steady state)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following multiple oral dose administration)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours after last dose
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 18 Jul 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 BI 201335 NA 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 23 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 18 Jul 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?
Number of patients with abnormal findings in physical examination (time frame: Baseline and up to 46 days). 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 18 Jul 2014.