HIV InfectionsPhase 1NCT01276990
Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 in Healthy Male Volunteers.
A Phase 1 study testing BI 224436 in people with HIV Infections and Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers following oral administration of repeated doses for 10 days within 8 dosing regimens. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Healthy
- What is being tested?
- BI 224436
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Sep 2012
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests.
- Age >=18 and <=50 years.
- Body Mass Index (BMI) >=18.5 and BMI <=32 kg/m2.
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.
- Documented to be sterile; or, if can father a child, agree to abstain from sexual intercourse during and at least seven days following last study drug administration, or are willing to use condoms during the same period each time (Subject's female sexual partner(s) of child-bearing potential should be willing to use either ethinyl estradiol containing oral contraceptives or a reliable barrier method of contraception).
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance according to the opinion of the investigator.
- Any evidence of a clinically relevant concomitant disease.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Surgery of the gastrointestinal tract that in the opinion of the investigator may affect the absorption.
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
- History of relevant orthostatic hypotension, fainting spells or blackouts.
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- History or evidence of Human Immunodeficiency Virus or other chronic or relevant acute infections, including Hepatitis C Virus and Hepatitis B Virus infection.
- History of relevant allergy / hypersensitivity (including allergy to investigational medicinal product or its solvent).
- History of any familial skeletal muscle disorder, or history of Creatine Kinase (CK) elevation not due to strenuous physical activity or trauma.
- 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, including prescription and non-prescription drugs, and St. Johns Wort which might reasonably influence the results of the trial within 14 days prior to study drug administration or during the trial, or consumption of grapefruit, grapefruit juice, orange juice, Seville oranges, green tea, pineapple, pineapple juice, broccoli or red wine within 3 days prior study drug administration or during the trial.
- Participation in another trial with an investigational drug within one month prior to administration or during the trial.
- Current smoker (>10 cigarettes or >3 cigars or >3 pipes / day).
- Inability to refrain from smoking during the trial.
- Alcohol abuse (more than 30 g day).
- Drug abuse.
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
- Physical activity in excess of usual activity of daily living (e.g., fitness physical exercise, physical labor) within 7 days prior to study drug administration until end of study visit.
- Any laboratory value outside the reference range that in the opinion of the investigator is of clinical relevance.
- A marked baseline prolongation of QT or corrected QT (QTc) intervals (e.g., repeated demonstration of a QTc interval >450 ms); or, other ECG abnormality of clinical significance.
- A history of additional risk factors for Torsades de points (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- CK at screening =2x Upper Limit of Normal (ULN) (If CK is =2xULN and <5xULN one retest will be allowed to verify the result).
- CK at baseline (Day -1) >ULN (If CK is >ULN and <1.5xULN one retest will be allowed to verify the result).
- Thyroid - stimulating hormone outside normal reference range, or history of hypo-or hyperthyroidism.
About this study
Official title: Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 ZW (Powder in Bottle Formulation) at 12.5 mg q24h, 12.5 mg q12h, 12.5 mg q8h, 25 mg q12h, 25 mg q8h, 50 mg q12h, 37.5 mg q8h and 50 mg q8h Dose Levels for 10 Days in Healthy Male Volunteers (Randomized, Double-blind Placebo-controlled Within Dose Groups)
To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers following oral administration of repeated doses for 10 days within 8 dosing regimens.
- Conditions
- HIV Infections, Healthy
- Being tested
- BI 224436, Placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 224436Drug
Oral drinking solution
BI 224436Drug
Oral drinking solution
BI 224436Drug
Oral drinking solution
BI 224436Drug
Oral drinking solution
BI 224436Drug
Oral drinking solution
BI 224436Drug
Oral drinking solution
BI 224436Drug
Oral drinking solution
BI 224436Drug
Oral drinking solution
BI 224436Drug
Oral drinking solution
PlaceboDrug
Oral drinking solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo in dosing regimen 1-8 Receives: Drug: BI 224436; Drug: Placebo |
| BI 224436 dosing regimen 1 | Experimental | Dosing regimen 1 Receives: Drug: BI 224436 |
| BI 224436 dosing regimen 2 | Experimental | Dosing regimen 2 Receives: Drug: BI 224436 |
| BI 224436 dosing regimen 3 | Experimental | Dosing regimen 3 Receives: Drug: BI 224436 |
| BI 224436 dosing regimen 4 | Experimental | Dosing regimen 4 Receives: Drug: BI 224436 |
| BI 224436 dosing regimen 5 | Experimental | Dosing regimen 5 Receives: Drug: BI 224436 |
| BI 224436 dosing regimen 6 | Experimental | Dosing regimen 6 Receives: Drug: BI 224436 |
| BI 224436 dosing regimen 7 | Experimental | Dosing regimen 7 Receives: Drug: BI 224436 |
| BI 224436 dosing regimen 8 | Experimental | Dosing regimen 8 Receives: Drug: BI 224436 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure
Measured: 1 month
Changes in pulse rate
Measured: 1 month
Changes in 12-lead ECG
Measured: 1 month
Changes in clinical laboratory test parameters
Measured: 1 month
Adverse events
Measured: 1 month
Secondary outcomes (6)
Cmax,ss (maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval t)
Measured: 10 days
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady-state)
Measured: 10 Days
Cmin,ss (minimum concentration of the analyte in plasma at steady-state over a uniform dosing interval t)
Measured: 10 days
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval t)
Measured: 13 days
t1/2,ss (terminal half-life of the analyte in plasma at steady-state)
Measured: 13 days
CL/F,ss (apparent clearance of the analyte in the plasma at steady-state following extravascular multiple dose administration)
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276990
- Sponsor's protocol ID
- 1277.2
- Status last verified
- Feb 2012
- First submitted
- 13 Jan 2011
- Last updated
- 9 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 ZW (Powder in Bottle Formulation) at 12.5 mg q24h, 12.5 mg q12h, 12.5 mg q8h, 25 mg q12h, 25 mg q8h, 50 mg q12h, 37.5 mg q8h and 50 mg q8h Dose Levels for 10 Days in Healthy Male Volunteers (Randomized, Double-blind Placebo-controlled Within Dose Groups)
- ClinicalTrials.gov ID
- NCT01276990
- Acronym / sponsor ID
- 1277.2
- Conditions
- HIV Infections, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (estimated)
- First posted
- 14 Jan 2011 (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 investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers following oral administration of repeated doses for 10 days within 8 dosing regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: BI 224436, Drug: PlaceboMatching placebo in dosing regimen 1-8 |
| BI 224436 dosing regimen 1 | Experimental | Drug: BI 224436Dosing regimen 1 |
| BI 224436 dosing regimen 2 | Experimental | Drug: BI 224436Dosing regimen 2 |
| BI 224436 dosing regimen 3 | Experimental | Drug: BI 224436Dosing regimen 3 |
| BI 224436 dosing regimen 4 | Experimental | Drug: BI 224436Dosing regimen 4 |
| BI 224436 dosing regimen 5 | Experimental | Drug: BI 224436Dosing regimen 5 |
| BI 224436 dosing regimen 6 | Experimental | Drug: BI 224436Dosing regimen 6 |
| BI 224436 dosing regimen 7 | Experimental | Drug: BI 224436Dosing regimen 7 |
| BI 224436 dosing regimen 8 | Experimental | Drug: BI 224436Dosing regimen 8 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests.
- Age >=18 and <=50 years.
- Body Mass Index (BMI) >=18.5 and BMI <=32 kg/m2.
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.
- Documented to be sterile; or, if can father a child, agree to abstain from sexual intercourse during and at least seven days following last study drug administration, or are willing to use condoms during the same period each time (Subject's female sexual partner(s) of child-bearing potential should be willing to use either ethinyl estradiol containing oral contraceptives or a reliable barrier method of contraception).
Key exclusion criteria (24 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance according to the opinion of the investigator.
- Any evidence of a clinically relevant concomitant disease.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Surgery of the gastrointestinal tract that in the opinion of the investigator may affect the absorption.
- 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 |
|---|---|---|
| BI 224436Oral drinking solution | Drug | BI 224436 dosing regimen 6 |
| BI 224436Oral drinking solution | Drug | BI 224436 dosing regimen 8 |
| BI 224436Oral drinking solution | Drug | BI 224436 dosing regimen 2 |
| BI 224436Oral drinking solution | Drug | BI 224436 dosing regimen 3 |
| BI 224436Oral drinking solution | Drug | BI 224436 dosing regimen 4 |
| BI 224436Oral drinking solution | Drug | BI 224436 dosing regimen 5 |
| BI 224436Oral drinking solution | Drug | BI 224436 dosing regimen 7 |
| BI 224436Oral drinking solution | Drug | Placebo |
| BI 224436Oral drinking solution | Drug | BI 224436 dosing regimen 1 |
| PlaceboOral drinking solution | Drug | Placebo |
Primary outcome
Changes in blood pressure
Time frame: 1 month
Changes in pulse rate
Time frame: 1 month
Changes in 12-lead ECG
Time frame: 1 month
Changes in clinical laboratory test parameters
Time frame: 1 month
Adverse events
Time frame: 1 month
6 secondary outcomes
Cmax,ss (maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval t)
Time frame: 10 days
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady-state)
Time frame: 10 Days
Cmin,ss (minimum concentration of the analyte in plasma at steady-state over a uniform dosing interval t)
Time frame: 10 days
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval t)
Time frame: 13 days
t1/2,ss (terminal half-life of the analyte in plasma at steady-state)
Time frame: 13 days
CL/F,ss (apparent clearance of the analyte in the plasma at steady-state following extravascular multiple dose administration)
Time frame: 13 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 224436 in people with HIV Infections and 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 24 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: withdrawn, as of the sponsor's last update on 9 Feb 2012. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in blood pressure (time frame: 1 month). 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 9 Feb 2012.