HealthyPhase 1NCT02226978
Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir (TPV/r) With Single-dose Valaciclovir (VAL) in Healthy Volunteers
A Phase 1 study testing Tipranavir, Ritonavir and Valaciclovir in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a prodrug of aciclovir (ACV) Read more about this study
- Who is it for?
- Ages 20 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tipranavir, Ritonavir and Valaciclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to May 2007
- 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 20 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and non-pregnant, non-lactating female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and willingness to comply with all study requirements
- Age >19 and <59 years (20 - 58 years inclusive)
- Weight ≥ 60 kg
- Body mass index (BMI) >18.5 and <29.9 kg/m2
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Atrioventricular (AV) block including 1°
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells or blackouts
Show all 26Show fewer
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Known hypersensitivity to TPV, RTV, valaciclovir, aciclovir or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
- Known elevated liver enzymes in past trials with any compound
- Intake of drugs with a long half-life (>24 hours) (<1 month prior to administration)
- Prescription or over the counter medications (including vitamins, minerals, herbal supplements and antacids), dietary supplements 14 days prior to study drug administration or expected during the trial)
- Participation in another trial with an investigational drug (<2 months prior to administration or expected during trial)
- Smoker with a consumption of >10 cigarettes or >3 cigars or >3 pipes/day and those who cannot keep tobacco intake constant
- Alcohol (>40 g/day for males and >20 g/day for females) and drug abuse
- Blood donation or loss >400 mL, < 3 month prior to administration
- Clinically relevant laboratory abnormalities
- Transaminases above reference values in the history
- Inability to comply with dietary regimen of study centre
- For female subjects:
- Pregnancy or planning to become pregnant within 60 days of study completion
- Positive pregnancy test
- Have not been using a barrier method of contraception for at least 3 months prior to participation in the study if of childbearing potential and not surgically sterilized
- Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial if of childbearing potential and not surgically sterilized
- Chronic use of oral contraception or hormone replacement containing ethinyl estradiol
- Breast-feeding
About this study
Official title: An Open-label One-sequence Cross-over Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir 500/200 mg With Single-dose Valaciclovir (500 mg) in Healthy Volunteers
Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a prodrug of aciclovir (ACV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TipranavirDrug
RitonavirDrug
ValaciclovirDrug
| Study group | Role | What they receive |
|---|---|---|
| TPV/r with valaciclovir | Experimental | VAL 2 days (on days 1 and 13), TPV/r 12 days (on days 2 to 13) Receives: Drug: Tipranavir; Drug: Ritonavir; Drug: Valaciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of aciclovir in plasma over the time interval t0h to t12h (AUC0-12)
Measured: up to 12 hours after drug administration
Maximum measured concentration of aciclovir in plasma (Cmax)
Measured: up to 12 hours after drug administration
Secondary outcomes (11)
AUC0-12 for Tipranavir (TPV)
Measured: up to 12 hours after drug administration
Cmax for TPV
Measured: up to 12 hours after drug administration
Drug concentration of TPV in plasma at 12 hours after administration (C12h)
Measured: up to 12 hours after drug administration
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Measured: up to 12 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Measured: up to 12 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to 12 hours after drug administration
Number of subjects with adverse events
Measured: up to 14 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 14 days after last drug administration
AUC0-12 for Ritonavir (RTV)
Measured: up to 12 hours after drug administration
Cmax for RTV
Measured: up to 12 hours after drug administration
Drug concentration of RTV in plasma at 12 hours after administration (C12h)
Measured: up to 12 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 posted27 Aug 2014 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT02226978
- Sponsor's protocol ID
- 1182.104
- Status last verified
- Aug 2014
- First submitted
- 26 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label One-sequence Cross-over Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir 500/200 mg With Single-dose Valaciclovir (500 mg) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02226978
- Acronym / sponsor ID
- 1182.104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- May 2007 (actual)
- First posted
- 27 Aug 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.
Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a prodrug of aciclovir (ACV)
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPV/r with valaciclovir | Experimental | Drug: Tipranavir, Drug: Ritonavir, Drug: ValaciclovirVAL 2 days (on days 1 and 13), TPV/r 12 days (on days 2 to 13) |
Who may qualify
- Ages
- 20 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and non-pregnant, non-lactating female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and willingness to comply with all study requirements
- Age >19 and <59 years (20 - 58 years inclusive)
- Weight ≥ 60 kg
Key exclusion criteria (26 listed)
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Atrioventricular (AV) block including 1°
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| Tipranavir | Drug | TPV/r with valaciclovir |
| Ritonavir | Drug | TPV/r with valaciclovir |
| Valaciclovir | Drug | TPV/r with valaciclovir |
Primary outcome
Area under the concentration-time curve of aciclovir in plasma over the time interval t0h to t12h (AUC0-12)
Time frame: up to 12 hours after drug administration
Maximum measured concentration of aciclovir in plasma (Cmax)
Time frame: up to 12 hours after drug administration
11 secondary outcomes
AUC0-12 for Tipranavir (TPV)
Time frame: up to 12 hours after drug administration
Cmax for TPV
Time frame: up to 12 hours after drug administration
Drug concentration of TPV in plasma at 12 hours after administration (C12h)
Time frame: up to 12 hours after drug administration
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time frame: up to 12 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: up to 12 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 12 hours after drug administration
Number of subjects with adverse events
Time frame: up to 14 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 14 days after last drug administration
AUC0-12 for Ritonavir (RTV)
Time frame: up to 12 hours after drug administration
Cmax for RTV
Time frame: up to 12 hours after drug administration
Drug concentration of RTV in plasma at 12 hours after administration (C12h)
Time frame: up to 12 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 27 Aug 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 Tipranavir, Ritonavir and Valaciclovir 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 6 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 27 Aug 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?
Area under the concentration-time curve of aciclovir in plasma over the time interval t0h to t12h (AUC0-12) (time frame: up to 12 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 27 Aug 2014.