HealthyPhase 1NCT02248883
Electrophysiological Effects of Tipranavir Co-administered With Ritonavir on the QT Interval in Healthy Female and Male Subjects
A Phase 1 study testing TPV low, Moxifloxacin and TPV high in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the QT interval more than placebo co-administered with ritonavir Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TPV low, Moxifloxacin and TPV high
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Mar 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female and male volunteers as determined by the results of screening according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- Age ≥ 18 and Age ≤ 55 years
- 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 GCP and the local legislation
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Gastrointestinal tract surgery (except appendectomy)
- Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Relevant acute, chronic or active chronic infections (e.g. hepatitis, HIV).
- History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
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- 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 based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- History of any bleeding disorder or acute blood coagulation defect
- Hypersensitivity to ritonavir, moxifloxacin and/or related drugs of these classes
- History of Glucose-6-phosphate-deficiency
- Excessive physical activities (within one week prior to trial or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- A history of additional risk factors for torsade de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Heart rate at screening of > 80 bpm or < 45 bpm
- Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval > 240 ms, QRS interval > 120 ms, QTcB or QTcF > 450 ms, or QT (uncorrected) > 470 ms
- Inability to comply with the dietary regimen of the study centre
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilisation, intrauterine pessary (IUP) or oral contraception not containing ethinyl estradiol)
- Oral contraception containing ethinyl estradiol without the use of an additional barrier method
- Hormone replacement containing ethinyl estradiol
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: Assessment of Electrophysiological Effects of Tipranavir Co-administered With Ritonavir Given b.i.d. for 2.5 Days on the QT Interval in Healthy Female and Male Subjects. A Double-blind, Randomised, Placebo Controlled, Two-way Crossover Study With a Positive Control (Moxifloxacin) and Parallel Dose Groups
To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the QT interval more than placebo co-administered with ritonavir
- Conditions
- Healthy
- Being tested
- TPV low, Placebo, Moxifloxacin, TPV high, RTV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPV lowDrug
PlaceboDrug
MoxifloxacinDrug
Also called Avelox®
TPV highDrug
RTVDrug
| Study group | Role | What they receive |
|---|---|---|
| low TPV/RTV | Experimental | Not described Receives: Drug: TPV low; Drug: Moxifloxacin; Drug: RTV |
| high TPV/RTV | Experimental | Not described Receives: Drug: Moxifloxacin; Drug: TPV high; Drug: RTV |
| Placebo/RTV | Experimental | Not described Receives: Drug: Placebo; Drug: Moxifloxacin; Drug: RTV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in individually heart rate corrected QT interval length (QTcI)
Measured: baseline and 2 to 4 hours after drug administration on day3
Secondary outcomes (2)
Change from baseline in (QTcI)
Measured: baseline and 2 to 4 hours after drug administration on day 1
Change from baseline in (QTcI)
Measured: baseline and 1 to 12 hours after drug administration on day1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startDec 2005
- Primary completionMar 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
- Double blind
- Enrolment
- 81 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
- NCT02248883
- Sponsor's protocol ID
- 1182.60
- Status last verified
- Sep 2014
- First submitted
- 24 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Electrophysiological Effects of Tipranavir Co-administered With Ritonavir Given b.i.d. for 2.5 Days on the QT Interval in Healthy Female and Male Subjects. A Double-blind, Randomised, Placebo Controlled, Two-way Crossover Study With a Positive Control (Moxifloxacin) and Parallel Dose Groups
- ClinicalTrials.gov ID
- NCT02248883
- Acronym / sponsor ID
- 1182.60
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Mar 2006 (actual)
- First posted
- 25 Sep 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 tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the QT interval more than placebo co-administered with ritonavir
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low TPV/RTV | Experimental | Drug: TPV low, Drug: Moxifloxacin, Drug: RTV |
| high TPV/RTV | Experimental | Drug: Moxifloxacin, Drug: TPV high, Drug: RTV |
| Placebo/RTV | Experimental | Drug: Placebo, Drug: Moxifloxacin, Drug: RTV |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female and male volunteers as determined by the results of screening according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- Age ≥ 18 and Age ≤ 55 years
- 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 GCP and the local legislation
Key exclusion criteria (32 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Gastrointestinal tract surgery (except appendectomy)
- Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Relevant acute, chronic or active chronic infections (e.g. hepatitis, HIV).
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 |
|---|---|---|
| TPV low | Drug | low TPV/RTV |
| Placebo | Drug | Placebo/RTV |
| MoxifloxacinAlso: Avelox® | Drug | Placebo/RTV, high TPV/RTV, low TPV/RTV |
| TPV high | Drug | high TPV/RTV |
| RTV | Drug | Placebo/RTV, high TPV/RTV, low TPV/RTV |
Primary outcome
Change from baseline in individually heart rate corrected QT interval length (QTcI)
Time frame: baseline and 2 to 4 hours after drug administration on day3
2 secondary outcomes
Change from baseline in (QTcI)
Time frame: baseline and 2 to 4 hours after drug administration on day 1
Change from baseline in (QTcI)
Time frame: baseline and 1 to 12 hours after drug administration on day1 and 3
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 25 Sep 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 TPV low, Moxifloxacin and TPV high 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 32 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 25 Sep 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?
Change from baseline in individually heart rate corrected QT interval length (QTcI) (time frame: baseline and 2 to 4 hours after drug administration on day3). 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 25 Sep 2014.