HealthyPhase 1NCT02171832
Single Dose of BI 1744 CL in Patients With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
A Phase 1 study testing BI 1744 CL, low dose and BI 1744 CL, high dose in people with Healthy and Liver Diseases, run by Boehringer Ingelheim.
Trial summary
The main objective of this study was to investigate the influence of mild and moderate liver impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744 CL in comparison to a control group with normal hepatic function after single orally inhaled administration of BI 1744 CL with the… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Liver Diseases
- What is being tested?
- BI 1744 CL, low dose and BI 1744 CL, high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Dec 2009
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects:
- Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests. The healthy subjects must meet the matching criteria based on the matching approach
- Age >21 and <75 years
- Body Mass Index (BMI) >18.5 and <32 kg/m2
- Creatinine clearance >70 mL/min according to Cockcroft \& Gault
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Show all 14Show fewer
- Hepatically impaired subjects:
- Hepatically male and female impaired subjects determined by results of screening classified as
- Group 1 (Child-Pugh A; Child-Pugh score of 5-6 points) and as
- Group 2 (Child-Pugh B; Child-Pugh score of 7-9 points)
- Age >21 and <75 years
- BMI >18.5 and <34 kg/m2
- Creatinine clearance >40 mL/min according to Cockcroft \& Gault (for hepatically impaired patients)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Who cannot join
- Healthy subjects who meet any of the following criteria will not be entered into this trial:
- Any finding of the medical examination (including BP [>140 mmHg systolic and or >95 mmHg diastolic], PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant gastrointestinal tract surgery (except appendectomy, herniotomy)
- Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders
Show all 61Show fewer
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections (e.g. including Hepatitis B and C and HIV)
- History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
- History or presence of allergy against iodine and/or contrast agent, latent or manifest hyperthyrosis or allergic diathesis to indocyanine green
- Intake of drugs that are contraindicated in connection with the indocyanine green test
- 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
- Participation in another trial with an investigational drug within one month after previous single dose administration or two months after previous multiple dose administration prior to administration or during the trial
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking when confined to the study site on trial days
- Alcohol abuse (more than 40 g/day in males, more than 20 g/day in females)
- Drug abuse, in the investigator's judgement upon review of the patient's history and urine screening for abused substances
- Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within 48 hours prior to trial or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance in the opinion of the investigator
- Inability to comply with dietary regimen of study centre
- Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Hepatically impaired subjects who meet any of the following criteria will not be entered into this trial:
- Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
- Severe cerebrovascular or cardiac disorders, e.g. myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association (NYHA) grade III or IV, severe arrhythmia
- Relevant gastrointestinal tract surgery (except appendectomy, herniotomy, oesophagean varices)
- Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders
- Evidence of hepatic encephalopathy related to chronic liver disease > grade 2 (exclusion by Number Connection Test)
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Resting heart rate in the awake subject below 45 beats per minute (BPM) or above 100 BPM; Systolic blood pressure below 100 mmHg or above 160 mmHg, Diastolic blood pressure above 95 mmHg
- Chronic or relevant acute infections (e.g. HIV) except e.g. Hepatitis B and C
- History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
- History or presence of allergy against iodine and/or contrast agent, latent or manifest hyperthyrosis or allergic diathesis to indocyanine green
- 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, excluded are those drugs, the patient is currently taking for treatment of the hepatic or concomitant disease.
- Change of chronic medication less than 4 weeks prior to dosing
- Participation in another trial with an investigational drug within one month after previous single dose administration or two months after previous multiple dose administration prior to administration or during the trial
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking when confined to the study site on trial days
- Alcohol abuse (more than 60 g/day in males, more than 40 g/day in females)
- Drug abuse, in the investigator's judgement upon review of the patient's history and urine screening for abused substances
- Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- History of Gastro intestinal tract bleeding within the past 3 months
- Excessive physical activities (within 48 hours prior to trial or during the trial)
- Clinically relevant laboratory abnormalities (except for liver function tests according to Child-Pugh classification or laboratory constellations of parameters that are typically altered in patients fulfilling the Child Pugh criteria) including relevant electrolyte disturbances
- Serum albumin <20 g/L
- Hemoglobin <8 g/dL
- Inability to comply with dietary regimen of study centre
- Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Exclusion criteria specific for this study due to the known class side effect profile of ß2- mimetics (for healthy or hepatically impaired subjects):
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- For female subjects (healthy or hepatically impaired):
- Pregnancy or planning to become pregnant within 2 months of study completion
- Positive pregnancy test
- No adequate contraception in women of childbearing potential (adequate contraception: e.g. sterilisation, intrauterine device or oral contraception not containing ethinyl estradiol or ethinyl estradiol with an additional barrier method) for at least 3 months prior to participation in the study
- Inability to maintain this adequate contraception during the whole trial period.
- Lactation period
About this study
Official title: Pharmacokinetics, Safety and Tolerability of a Single Dose of BI 1744 CL (20 μg Administered With the Respimat® Inhaler) in Patients With Mild and Moderate Hepatic Impairment (Child Pugh Classifications A and B) in Comparison to a Single Dose of BI 1744 CL (30 μg Administered With the Respimat® Inhaler) in Subjects With Normal Hepatic Function in a Monocentric, Open Label, Parallel Group Phase I Trial
The main objective of this study was to investigate the influence of mild and moderate liver impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744 CL in comparison to a control group with normal hepatic function after single orally inhaled administration of BI 1744 CL with the Respimat® Inhaler.
- Conditions
- Healthy, Liver Diseases
- Being tested
- BI 1744 CL, low dose, BI 1744 CL, high dose
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1744 CL, low doseDrug
BI 1744 CL, high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Mildly liver impaired patients | Experimental | Not described Receives: Drug: BI 1744 CL, low dose |
| Moderately liver impaired patients | Experimental | Not described Receives: Drug: BI 1744 CL, low dose |
| Healthy volunteers | Experimental | Not described Receives: Drug: BI 1744 CL, high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞,norm (dose-normalized area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Cmax,norm (dose-normalized maximum concentration of the analyte in plasma)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Secondary outcomes (21)
AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Cmax (maximum concentration of the analyte in plasma)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
AUC0-tz(,norm) ((dose-normalized ) area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
λz (terminal rate constant in plasma)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
MRTih (mean residence time of the analyte in plasma in the body after inhalation)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to t2)
Measured: before and 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
fet1-t2 (fraction of analyte excreted in urine from the time point t1 to t2)
Measured: before and 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
CLR,t1-t2 (renal clearance of the analyte in urine from the time point t1 to t2)
Measured: before and 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
Plasma protein binding
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
CL (total clearance of the analyte in plasma after intravascular administration)
Measured: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Number of patients with abnormal findings in physical examination
Measured: Baseline, day 14
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))
Measured: Baseline, up to day 14
Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)
Measured: Baseline, up to day 14
Number of patients with clinically significant changes in clinical laboratory tests
Measured: Baseline, up to day 14
Number of patients with adverse events
Measured: 5 weeks
Assessment of tolerability by the investigator on a 4-point scale
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJul 2009
- Primary completionDec 2009
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT02171832
- Sponsor's protocol ID
- 1222.20
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety and Tolerability of a Single Dose of BI 1744 CL (20 μg Administered With the Respimat® Inhaler) in Patients With Mild and Moderate Hepatic Impairment (Child Pugh Classifications A and B) in Comparison to a Single Dose of BI 1744 CL (30 μg Administered With the Respimat® Inhaler) in Subjects With Normal Hepatic Function in a Monocentric, Open Label, Parallel Group Phase I Trial
- ClinicalTrials.gov ID
- NCT02171832
- Acronym / sponsor ID
- 1222.20
- Conditions
- Healthy, Liver Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- First posted
- 24 Jun 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.
The main objective of this study was to investigate the influence of mild and moderate liver impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744 CL in comparison to a control group with normal hepatic function after single orally inhaled administration of BI 1744 CL with the Respimat® Inhaler.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mildly liver impaired patients | Experimental | Drug: BI 1744 CL, low dose |
| Moderately liver impaired patients | Experimental | Drug: BI 1744 CL, low dose |
| Healthy volunteers | Experimental | Drug: BI 1744 CL, high dose |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests. The healthy subjects must meet the matching criteria based on the matching approach
- Age >21 and <75 years
- Body Mass Index (BMI) >18.5 and <32 kg/m2
- Creatinine clearance >70 mL/min according to Cockcroft \& Gault
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Key exclusion criteria (61 listed)
- Healthy subjects who meet any of the following criteria will not be entered into this trial:
- Any finding of the medical examination (including BP [>140 mmHg systolic and or >95 mmHg diastolic], PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant gastrointestinal tract surgery (except appendectomy, herniotomy)
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 1744 CL, low dose | Drug | Mildly liver impaired patients, Moderately liver impaired patients |
| BI 1744 CL, high dose | Drug | Healthy volunteers |
Primary outcome
AUC0-∞,norm (dose-normalized area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Cmax,norm (dose-normalized maximum concentration of the analyte in plasma)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
21 secondary outcomes
AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
AUC0-tz(,norm) ((dose-normalized ) area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
λz (terminal rate constant in plasma)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
MRTih (mean residence time of the analyte in plasma in the body after inhalation)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to t2)
Time frame: before and 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
fet1-t2 (fraction of analyte excreted in urine from the time point t1 to t2)
Time frame: before and 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
CLR,t1-t2 (renal clearance of the analyte in urine from the time point t1 to t2)
Time frame: before and 0-8, 8-12, 12-24, 24-48, 48-72 hours following drug administration
Plasma protein binding
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
CL (total clearance of the analyte in plasma after intravascular administration)
Time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration
Number of patients with abnormal findings in physical examination
Time frame: Baseline, day 14
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))
Time frame: Baseline, up to day 14
Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)
Time frame: Baseline, up to day 14
Number of patients with clinically significant changes in clinical laboratory tests
Time frame: Baseline, up to day 14
Number of patients with adverse events
Time frame: 5 weeks
Assessment of tolerability by the investigator on a 4-point scale
Time frame: Day 14
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 24 Jun 2014.
- Related InfoLink provided by the sponsor.
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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 1744 CL, low dose and BI 1744 CL, high dose in people with Healthy and Liver Diseases, 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 14 inclusion and 61 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 24 Jun 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?
AUC0-∞,norm (dose-normalized area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following 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 24 Jun 2014.