HealthyPhase 1NCT02251873
Evaluation of the Pharmacokinetic Interaction of Steady State Tipranavir and Ritonavir or Tipranavir and Ritonavir With Single Dose Didanosine in Healthy Volunteers
A Phase 1 study testing TPV + RTV (low dose), TPV + RTV (high dose) and ddl in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV) administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the short-term safety of this combination Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TPV + RTV (low dose), TPV + RTV (high dose) and ddl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Mar 2002
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects as determined by results of screening
- Female subjects were not lactating and not of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone (FSH) with low estradiol and no estrogen supplementation). Females were to use barrier contraception (e.g. condoms) for at least one month prior to administration of study medication, during the study and at least one month after release from the study. Women were to have negative pregnancy tests
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=18 and <=60 years
- 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 ECG) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B, Hepatitis C, or HIV infection
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator including study drugs
Show all 21Show fewer
- Intake of drugs with a long half-life (> 24 hours) or enzyme altering drug within 1 month prior to administration of study drugs
- Use of any drugs that might have influenced the results of the trial within 10 days prior to administration or during the trial (in addition to specific medication prohibitions mentioned in exclusion criteria above)
- Use of grapefruit or grapefruit juice, alcohol, green tea, methylxanthine-containing products or tobacco within one week of study drug administration
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood or plasma donation within 1 month prior to administration or during the trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Following specific laboratory findings: activated partial thromboplastin time (aPTT), prothrombin time international normalised ratio (INR), aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl-transferase (GGT), amylase, lipase, or triglyceride above the normal range
- Any other laboratory value outside the clinically accepted reference range and of clinical relevance
- History of any familial bleeding disorder
- Inability to swallow multiple large capsules
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
About this study
Official title: An Open Label, Randomised, Parallel Group Study of the Drug-drug Pharmacokinetic Interaction of Steady State Tipranavir (SEDDS SEC) 500 mg and Ritonavir (Soft Gelatin Capsules) 100 mg or Tipranavir 750 mg and Ritonavir 200 mg, Both Bid for 13.5 Days With Single Dose Didanosine 400 mg (Delayed Release Capsule EC Beadlets) in Healthy Volunteers
Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV) administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the short-term safety of this combination
- Conditions
- Healthy
- Being tested
- TPV + RTV (low dose), TPV + RTV (high dose), ddl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPV + RTV (low dose)Drug
TPV + RTV (high dose)Drug
ddlDrug
| Study group | Role | What they receive |
|---|---|---|
| TPV + RTV (low dose)+ ddI | Experimental | Not described Receives: Drug: TPV + RTV (low dose); Drug: ddl |
| TPV+ RTV (high dose)+ ddI | Experimental | Not described Receives: Drug: TPV + RTV (high dose); Drug: ddl |
What is being measured
The primary outcome is the main question the study is designed to answer.
(AUC 0-12) Area under the plasma concentration time curve from 0-12 hours
Measured: up to 12 hours after dose administration
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 12 hours after dose administration
(C6h) drug concentration in plasma at 6 hours after drug administration
Measured: up to 6 hours after dose administration
(C12h) drug concentration in plasma at 12 hours after drug administration
Measured: up to 12 hours after dose administration
Cnh (plasma concentration n hours after drug administration)
Measured: up to 12 hours after dose administration
Secondary outcomes (8)
Cmax,ss (maximum plasma concentration at steady state)
Measured: up to 12 hours after dose administration
MRT (mean residence time)
Measured: up to 12 hours after dose administration
Tmax (time to the maximum plasma concentration)
Measured: up to 12 hours after dose administration
CL/F (apparent oral clearance)
Measured: up to 12 hours after dose administration
Vz/F (apparent volume of distribution)
Measured: up to 12 hours after dose administration
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 12 hours after dose administration
Number of subjects with adverse events
Measured: up to 40 days
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startSep 2001
- Primary completionMar 2002
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
- None (open label)
- Enrolment
- 50 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
- NCT02251873
- Sponsor's protocol ID
- 1182.42
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised, Parallel Group Study of the Drug-drug Pharmacokinetic Interaction of Steady State Tipranavir (SEDDS SEC) 500 mg and Ritonavir (Soft Gelatin Capsules) 100 mg or Tipranavir 750 mg and Ritonavir 200 mg, Both Bid for 13.5 Days With Single Dose Didanosine 400 mg (Delayed Release Capsule EC Beadlets) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02251873
- Acronym / sponsor ID
- 1182.42
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Mar 2002 (actual)
- First posted
- 29 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.
Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV) administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the short-term safety of this combination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPV + RTV (low dose)+ ddI | Experimental | Drug: TPV + RTV (low dose), Drug: ddl |
| TPV+ RTV (high dose)+ ddI | Experimental | Drug: TPV + RTV (high dose), Drug: ddl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects as determined by results of screening
- Female subjects were not lactating and not of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone (FSH) with low estradiol and no estrogen supplementation). Females were to use barrier contraception (e.g. condoms) for at least one month prior to administration of study medication, during the study and at least one month after release from the study. Women were to have negative pregnancy tests
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=18 and <=60 years
- Body mass index (BMI) >=18.5 and <=29.9 kg/m2
Key exclusion criteria (21 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B, Hepatitis C, or HIV infection
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- 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 |
|---|---|---|
| TPV + RTV (low dose) | Drug | TPV + RTV (low dose)+ ddI |
| TPV + RTV (high dose) | Drug | TPV+ RTV (high dose)+ ddI |
| ddl | Drug | TPV + RTV (low dose)+ ddI, TPV+ RTV (high dose)+ ddI |
Primary outcome
(AUC 0-12) Area under the plasma concentration time curve from 0-12 hours
Time frame: up to 12 hours after dose administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 12 hours after dose administration
(C6h) drug concentration in plasma at 6 hours after drug administration
Time frame: up to 6 hours after dose administration
(C12h) drug concentration in plasma at 12 hours after drug administration
Time frame: up to 12 hours after dose administration
Cnh (plasma concentration n hours after drug administration)
Time frame: up to 12 hours after dose administration
8 secondary outcomes
Cmax,ss (maximum plasma concentration at steady state)
Time frame: up to 12 hours after dose administration
MRT (mean residence time)
Time frame: up to 12 hours after dose administration
Tmax (time to the maximum plasma concentration)
Time frame: up to 12 hours after dose administration
CL/F (apparent oral clearance)
Time frame: up to 12 hours after dose administration
Vz/F (apparent volume of distribution)
Time frame: up to 12 hours after dose administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 12 hours after dose administration
Number of subjects with adverse events
Time frame: up to 40 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 40 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 29 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 + RTV (low dose), TPV + RTV (high dose) and ddl 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 21 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 29 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?
(AUC 0-12) Area under the plasma concentration time curve from 0-12 hours (time frame: up to 12 hours after dose administration). The study lists 5 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 29 Sep 2014.