HealthyPhase 1NCT02182310
Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects
A Phase 1 study testing BI 201335 low dose, Moxifloxacin and BI 201335 high dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To demonstrate that BI 201335 does not prolong the QT interval more than placebo. To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the cross-over part of the trial. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 201335 low dose, Moxifloxacin and BI 201335 high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy caucasian males and females, 18 to 50 years of age
- Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)
- Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (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 26Show fewer
- 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 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 (≤ 30 days prior to administration or during the trial)
- Heavy 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 deviation of a laboratory value that is considered to be of clinical relevance
- Excessive physical activities within the last week before the trial or during the trial
- Hypersensitivity to BI 201335, moxifloxacin or related drugs of these classes
- Homozygous genotype status for "Gilbert" polymorphisms (Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1)*28, *60)
- Heart rate at screening of > 85 bpm or < 40 bpm
- Any screening ECG value outside of the reference range of clinical relevance including, but not limited to pulse rate (PR) interval > 220 ms, QRS interval > 115 ms, QTcB (QT interval, corrected for heart rate according to Bazett's formula) > 470 ms, or QT (uncorrected) > 470 ms
- For Female subjects
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilisation, intrauterine pressure , oral contraceptives). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
- Inability to maintain this adequate contraception during the whole study period from the time of screening until one month after the last intake
- Lactation period
About this study
Official title: Assessment of the Effect of 480 mg and 1200 mg of BI 201335 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Four-way Crossover Phase-I-study With Moxifloxacin as Positive Control
To demonstrate that BI 201335 does not prolong the QT interval more than placebo.
To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the cross-over part of the trial.
- Conditions
- Healthy
- Being tested
- BI 201335 low dose, BI 201335 placebo, Moxifloxacin, BI 201335 high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 201335 low doseDrug
BI 201335 placeboDrug
MoxifloxacinDrug
BI 201335 high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 201335 placebo | Placebo comparator | crossover part Receives: Drug: BI 201335 placebo |
| BI 201335 low dose | Experimental | crossover part Receives: Drug: BI 201335 low dose |
| BI 201335 high dose | Experimental | crossover part Receives: Drug: BI 201335 high dose |
| Moxifloxacin | Active comparator | crossover part Receives: Drug: Moxifloxacin |
| BI 201335 or Placebo | Experimental | tolerability part in female subjects Receives: Drug: BI 201335 placebo; Drug: BI 201335 high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTcI interval (QT interval individually corrected for heart rate)
Measured: pre-dose and 3 to 8 hours
Secondary outcomes (3)
The mean value of QTcI changes from baseline between 2 h and 24 h after dosing
Measured: Pre dose and 2 to 24 hours post dosing
The change from mean baseline of the QTcI at any point in time between 2 h and 24 h after dosing
Measured: Pre dose and 2 to 24 hours post dosing
The time-matched changes versus placebo in QTcI at any point in time between 2 h and 24 h after dosing
Measured: Pre dose and 2 to 24 hours post dosing
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 startJun 2008
- Primary completionOct 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
- Crossover
- Masking
- Double blind
- Enrolment
- 56 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
- NCT02182310
- Sponsor's protocol ID
- 1220.16
- 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
- Assessment of the Effect of 480 mg and 1200 mg of BI 201335 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Four-way Crossover Phase-I-study With Moxifloxacin as Positive Control
- ClinicalTrials.gov ID
- NCT02182310
- Acronym / sponsor ID
- 1220.16
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 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.
To demonstrate that BI 201335 does not prolong the QT interval more than placebo.
To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the cross-over part of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BI 201335 placebo | Placebo comparator | Drug: BI 201335 placebocrossover part |
| BI 201335 low dose | Experimental | Drug: BI 201335 low dosecrossover part |
| BI 201335 high dose | Experimental | Drug: BI 201335 high dosecrossover part |
| Moxifloxacin | Active comparator | Drug: Moxifloxacincrossover part |
| BI 201335 or Placebo | Experimental | Drug: BI 201335 placebo, Drug: BI 201335 high dosetolerability part in female subjects |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy caucasian males and females, 18 to 50 years of age
- Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)
- Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Key exclusion criteria (26 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (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 |
|---|---|---|
| BI 201335 low dose | Drug | BI 201335 low dose |
| BI 201335 placebo | Drug | BI 201335 or Placebo, BI 201335 placebo |
| Moxifloxacin | Drug | Moxifloxacin |
| BI 201335 high dose | Drug | BI 201335 high dose, BI 201335 or Placebo |
Primary outcome
QTcI interval (QT interval individually corrected for heart rate)
Time frame: pre-dose and 3 to 8 hours
3 secondary outcomes
The mean value of QTcI changes from baseline between 2 h and 24 h after dosing
Time frame: Pre dose and 2 to 24 hours post dosing
The change from mean baseline of the QTcI at any point in time between 2 h and 24 h after dosing
Time frame: Pre dose and 2 to 24 hours post dosing
The time-matched changes versus placebo in QTcI at any point in time between 2 h and 24 h after dosing
Time frame: Pre dose and 2 to 24 hours post dosing
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 low dose, Moxifloxacin and BI 201335 high dose 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 3 inclusion and 26 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?
QTcI interval (QT interval individually corrected for heart rate) (time frame: pre-dose and 3 to 8 hours). 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.