HealthyPhase 1NCT02253849
Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers
A Phase 1 study testing Carbamazepine, Tipranavir and Ritonavir in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg twice daily, depending on tolerability, and administered alone and in combination with tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg twice-daily) 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?
- Carbamazepine, Tipranavir and Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Jun 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 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 must be willing to comply with all study requirements
- Age >19 and <59 years
- Weight ≥ 60 kg
- BMI >18.5 and <35 kg/m2
- Ability to maintain adequate contraception if applicable
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- AV block including 1°
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, 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, Ritonavir (RTV), carbamazepine 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 or during the trial)
- 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 abuse (>60 g/day)
- Drug abuse
- Blood donation or loss >400 mL, <1 month prior to administration or expected during the trial
- Clinically relevant laboratory abnormalities
- 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
- 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
- Chronic use of oral contraception or hormone replacement containing ethinyl estradiol
- Breast-feeding
About this study
Official title: A Single Centre, Open-label Study With Healthy Adult Volunteers to Determine the Effects of Single-dose and Steady-state TPV/r 500/200 mg on the Steady-state Pharmacokinetics of Carbamazepine (200 mg Twice Daily)
Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg twice daily, depending on tolerability, and administered alone and in combination with tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg twice-daily)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
TipranavirDrug
RitonavirDrug
| Study group | Role | What they receive |
|---|---|---|
| CBZ - TPB/r+CBZ | Experimental | Days 1-14: carbamazepine (CBZ) twice daily
Days 15-22: CBZ twice daily plus TPV/r twice daily Receives: Drug: Carbamazepine; Drug: Tipranavir; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h)
Measured: up to 12 hours after drug administration
Maximum measured concentration of Carbamazepine in plasma (Cmax)
Measured: up to 12 hours after drug administration
Drug concentration of Carbamazepine in plasma at 12 hours after drug administration (Cp12h)
Measured: up to 12 hours after drug administration
Secondary outcomes (9)
AUC0-12h
Measured: up to 12 hours after drug administration
Cmax
Measured: up to 12 hours
Cp12h
Measured: up to 12 hours after drug administration
Clearance (CL/F)
Measured: up to 12 hours after drug administration
Volume of distribution
Measured: up to 12 hours after drug administration
Time from dosing to the maximum concentration (Tmax)
Measured: up to 12 hours after drug administration
t1/2 (terminal elimination half-life)
Measured: up to 12 hours after drug administration
Number of subjects with adverse events
Measured: up to 35 days
Number of subjects with clinically relevant changes in laboratory parameters
Measured: up to 35 days
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 startNov 2005
- Primary completionJun 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
- 28 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
- NCT02253849
- Sponsor's protocol ID
- 1182.80
- 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
- A Single Centre, Open-label Study With Healthy Adult Volunteers to Determine the Effects of Single-dose and Steady-state TPV/r 500/200 mg on the Steady-state Pharmacokinetics of Carbamazepine (200 mg Twice Daily)
- ClinicalTrials.gov ID
- NCT02253849
- Acronym / sponsor ID
- 1182.80
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jun 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.
Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg twice daily, depending on tolerability, and administered alone and in combination with tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg twice-daily)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBZ - TPB/r+CBZ | Experimental | Drug: Carbamazepine, Drug: Tipranavir, Drug: RitonavirDays 1-14: carbamazepine (CBZ) twice daily Days 15-22: CBZ twice daily plus TPV/r twice daily |
Who may qualify
- Ages
- 20 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 must be willing to comply with all study requirements
- Age >19 and <59 years
- 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
- AV block including 1°
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, 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 |
|---|---|---|
| Carbamazepine | Drug | CBZ - TPB/r+CBZ |
| Tipranavir | Drug | CBZ - TPB/r+CBZ |
| Ritonavir | Drug | CBZ - TPB/r+CBZ |
Primary outcome
Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h)
Time frame: up to 12 hours after drug administration
Maximum measured concentration of Carbamazepine in plasma (Cmax)
Time frame: up to 12 hours after drug administration
Drug concentration of Carbamazepine in plasma at 12 hours after drug administration (Cp12h)
Time frame: up to 12 hours after drug administration
9 secondary outcomes
AUC0-12h
Time frame: up to 12 hours after drug administration
Cmax
Time frame: up to 12 hours
Cp12h
Time frame: up to 12 hours after drug administration
Clearance (CL/F)
Time frame: up to 12 hours after drug administration
Volume of distribution
Time frame: up to 12 hours after drug administration
Time from dosing to the maximum concentration (Tmax)
Time frame: up to 12 hours after drug administration
t1/2 (terminal elimination half-life)
Time frame: up to 12 hours after drug administration
Number of subjects with adverse events
Time frame: up to 35 days
Number of subjects with clinically relevant changes in laboratory parameters
Time frame: up to 35 days
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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Carbamazepine, Tipranavir and Ritonavir 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 7 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 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?
Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h) (time frame: up to 12 hours after drug administration). The study lists 3 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.