HealthyPhase 1NCT02182375
Effect of BI 201335 Mediated UGT1A1 (Uridine-diphosphate-glucuronosyltransferases) Inhibition in Healthy Volunteers
A Phase 1 study testing BI 201335 NA and Raltegravir in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the effect of UGT1A1 inhibition by single and multiple oral doses of BI 201335 on the single and multiple oral dose pharmacokinetics of raltegravir and to investigate safety and tolerability. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 201335 NA and Raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Mar 2010
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females
- Age ranging ≥ 21 and ≤ 50 years
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Willing to complete all study-related activities including genotyping
- Volunteers give their written informed consent prior to admission to the study
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG (Electrocardiogram)) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of photosensitivity or recurrent rash
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or clinically relevant acute infections
Show all 28Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study (with the exception of hormonal contraceptives)
- Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the trial or during the trial
- Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
- 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 laboratory value outside the reference range if indicative of underlying disease or poor health
- Excessive physical activities within the last week before the trial or during the trial
- Hypersensitivity to treatment medication and/or related drugs of these classes
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF, or QTcB interval >450 ms)
- Vulnerable subjects (that is persons kept in detention)
- The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- For Female Subjects:
- Pregnancy
- Positive pregnancy test
- Lactation period
- No adequate contraception: females participating in the study must be either (1) of non-childbearing potential (e.g. surgically sterilized or postmenopausal with no menstrual bleeding for at least 2 years prior the study), or (2) using one of the following contraceptive methods plus condom during the course of the study and up to one month (i.e. one complete menstrual cycle) after the last administration of the study drug (whichever is longer): implants of levonorgestrel or injectable progestogen, oral contraceptive - combined or progestogen only, intrauterine device (IUD)- any IUD with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criteria)
- For Male Subjects:
- No adequate contraception: (1) surgically sterilized or (2) or use a condom plus another form of contraception (e.g. spermicide, IUD, birth control pills taken by female partner, diaphragm with spermicide). Male subjects must not father a child from administration of the first dose and up to 3 months after the last dose of study medication
About this study
Official title: An Open Label Fixed Sequence Phase I Study to Investigate the Effect of BI 201335 Mediated UGT1A1 Inhibition on the Multiple Oral Dose Pharmacokinetics of Raltegravir (Isentress®) in Healthy Male and Female Volunteers
Study to investigate the effect of UGT1A1 inhibition by single and multiple oral doses of BI 201335 on the single and multiple oral dose pharmacokinetics of raltegravir and to investigate safety and tolerability.
- Conditions
- Healthy
- Being tested
- BI 201335 NA, Raltegravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 201335 NADrug
RaltegravirDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 201335 NA | Experimental | 400 mg raltegravir (bid) from day 1-14 and once on day 15;
240 mg BI 201335 NA (bid) from day 7-14 with a loading dose of 480 mg in the morning of day 6 and once on day 15 Receives: Drug: BI 201335 NA; Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state Cmax,ss (maximum measured concentration) of raltegravir and raltegravir glucuronide
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
Steady-state AUC0-12h,ss (Area under the concentration-time curve) of raltegravir and raltegravir glucuronide
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
C12h,ss of raltegravir and raltegravir glucuronide
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
Secondary outcomes (19)
Number of patients with abnormal findings in physical examination
Measured: Baseline and within 7-14 days after last treatment
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Measured: Baseline and days 1, 5, 6, 7, 15 and within 7-14 days after last treatment
Number of patients with adverse events
Measured: up to 7 - 14 days after last treatment
Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)
Measured: Baseline, days 1, 5, 6, 7, 15 and within 7-14 days after last treatment
Number of patients with abnormal changes in laboratory tests (hematology, clinical chemistry, urine analysis)
Measured: Baseline, days 1, 2, 5, 6, 7, 8, 10, 12, 14, 15, 16 and within 7-14 days after last treatment
Assessment of tolerability by investigator on a 4-point scale
Measured: within 7-14 days after last treatment
Cmax,ss of BI 201335 ZW
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
C12h,ss of BI 201335 ZW
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
AUC0-12,ss of BI 201335 ZW
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
tmax,ss (Time from dosing to the maximum measured concentration) of BI 201335 ZW
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
CL/F0-12,ss (Total apparent clearance) of BI 201335 ZW
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
V/F0-12,ss (Apparent volume of distribution) of BI 201335 ZW
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
tmax,ss of raltegravir and raltegravir glucuronide
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
CL/F0-12,ss of raltegravir
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
V/F0-12,ss of raltegravir
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
t1/2 of raltegravir and raltegravir glucuronide
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
Ae (Amount of analyte eliminated in urine) of raltegravir and raltegravir glucuronide
Measured: pre-dose and 0-4, 4-8, 8-12 hours post-dose on day 5, 7, 15
CLR (Renal clearance) of raltegravir and raltegravir glucuronide
Measured: pre-dose and 0-4, 4-8, 8-12 hours post-dose on day 5, 7, 15
fe (Fraction of analyte eliminated in urine) of raltegravir and raltegravir glucuronide
Measured: pre-dose and 0-4, 4-8, 8-12 hours post-dose on day 5, 7, 15
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 startJan 2010
- Primary completionMar 2010
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
- 24 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
- NCT02182375
- Sponsor's protocol ID
- 1220.9
- 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
- An Open Label Fixed Sequence Phase I Study to Investigate the Effect of BI 201335 Mediated UGT1A1 Inhibition on the Multiple Oral Dose Pharmacokinetics of Raltegravir (Isentress®) in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02182375
- Acronym / sponsor ID
- 1220.9
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (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.
Study to investigate the effect of UGT1A1 inhibition by single and multiple oral doses of BI 201335 on the single and multiple oral dose pharmacokinetics of raltegravir and to investigate safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 201335 NA | Experimental | Drug: BI 201335 NA, Drug: Raltegravir400 mg raltegravir (bid) from day 1-14 and once on day 15; 240 mg BI 201335 NA (bid) from day 7-14 with a loading dose of 480 mg in the morning of day 6 and once on day 15 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males and females
- Age ranging ≥ 21 and ≤ 50 years
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Willing to complete all study-related activities including genotyping
- Volunteers give their written informed consent prior to admission to the study
Key exclusion criteria (28 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG (Electrocardiogram)) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of photosensitivity or recurrent rash
- History of orthostatic hypotension, fainting spells or blackouts
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 NA | Drug | BI 201335 NA |
| Raltegravir | Drug | BI 201335 NA |
Primary outcome
Steady-state Cmax,ss (maximum measured concentration) of raltegravir and raltegravir glucuronide
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
Steady-state AUC0-12h,ss (Area under the concentration-time curve) of raltegravir and raltegravir glucuronide
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
C12h,ss of raltegravir and raltegravir glucuronide
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
19 secondary outcomes
Number of patients with abnormal findings in physical examination
Time frame: Baseline and within 7-14 days after last treatment
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: Baseline and days 1, 5, 6, 7, 15 and within 7-14 days after last treatment
Number of patients with adverse events
Time frame: up to 7 - 14 days after last treatment
Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)
Time frame: Baseline, days 1, 5, 6, 7, 15 and within 7-14 days after last treatment
Number of patients with abnormal changes in laboratory tests (hematology, clinical chemistry, urine analysis)
Time frame: Baseline, days 1, 2, 5, 6, 7, 8, 10, 12, 14, 15, 16 and within 7-14 days after last treatment
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 7-14 days after last treatment
Cmax,ss of BI 201335 ZW
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
C12h,ss of BI 201335 ZW
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
AUC0-12,ss of BI 201335 ZW
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
tmax,ss (Time from dosing to the maximum measured concentration) of BI 201335 ZW
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
CL/F0-12,ss (Total apparent clearance) of BI 201335 ZW
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
V/F0-12,ss (Apparent volume of distribution) of BI 201335 ZW
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 7 and 15
tmax,ss of raltegravir and raltegravir glucuronide
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
CL/F0-12,ss of raltegravir
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
V/F0-12,ss of raltegravir
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
t1/2 of raltegravir and raltegravir glucuronide
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15
Ae (Amount of analyte eliminated in urine) of raltegravir and raltegravir glucuronide
Time frame: pre-dose and 0-4, 4-8, 8-12 hours post-dose on day 5, 7, 15
CLR (Renal clearance) of raltegravir and raltegravir glucuronide
Time frame: pre-dose and 0-4, 4-8, 8-12 hours post-dose on day 5, 7, 15
fe (Fraction of analyte eliminated in urine) of raltegravir and raltegravir glucuronide
Time frame: pre-dose and 0-4, 4-8, 8-12 hours post-dose on day 5, 7, 15
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 NA and Raltegravir 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 28 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. 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?
Steady-state Cmax,ss (maximum measured concentration) of raltegravir and raltegravir glucuronide (time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on day 5, 7 and 15). 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 18 Jul 2014.