Hepatic InsufficiencyPhase 1NCT00416702
Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function
A Phase 1 study testing QAB149 in people with Hepatic Insufficiency, run by Novartis at 1 site in United States.
Trial summary
This study is designed to evaluate the safety and pharmacokinetic effects of indacaterol in subjects with impaired liver function in comparison with healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- QAB149
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Mar 2008
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Groups
- Male and/or female subjects in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Female subjects of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom or oral contraception.
- OR:
- Postmenopausal women must have no regular menstrual bleeding for at least 1 years prior to inclusion. Menopause will be confirmed by a plasma FSH level of >40 IU/L
- OR:
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- Female subjects must have been surgically sterilized at least 6 months prior to screening.with supportive clinical documentation.
- AND/OR and MDS-specific requirement: If female subjects have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 month prior to first dosing.
- All females must have negative pregnancy test results at screening and baseline.
- Subjects must weigh at least 50 kg and have a body mass index (BMI) between 18 and 40 kg/m2 to participate in this study.
- Platelet count > 50,000 X 109/L at screening and baseline.
- Group 1 (healthy controls)
- In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening; subjects without diseases/conditions.
- Vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure, 90-<140 mm Hg, diastolic blood pressure, 60-<90 mm Hg, pulse rate, 50 - 100 beats per minute (bpm) When blood pressure and pulse will be taken again after at least 3 minutes standing, there shall be no more than a 20 mm Hg drop in systolic or 10 mm Hg drop in diastolic blood pressure and increase in heart rate (>20 bpm) associated with clinical manifestation of postural hypotension.
- Matched with a hepatic impaired patient on a 1:1 ration using the following criteria.sex, age ± 5 years, weight ± 10 kilograms, and smoking status
- Group 2, and 3 (hepatic impairment)
- Physical signs consistent with a clinical diagnosis of liver cirrhosis (i.e., liver firmness to palpation, splenic enlargement, spider angioma, palmar erythema, parotid hypertrophy, testicular atrophy, and gynecomastia).
- Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment.
- Otherwise considered healthy in general as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure, 90-<140 mm Hg, diastolic blood pressure, 60-<90 mm Hg, pulse rate, 50 - 100 beats per minute (bpm).
Who cannot join
- All Groups
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to study start.
- Significant illness within the 2 weeks prior to study start.
- A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
- Resting heart rate < 50 bpm
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- History of autonomic dysfunction or acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated) or clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), or a known hypersensitivity to the study drug or drugs similar to the study drug .
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study, including bowel, gastrointestinal, renal, pancreatic, hepatic, hematological, immunological, or neurological disorders
- Group 1 (healthy controls)
- Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin. SGPT will have to be strictly within the normal range before inclusion, GGT and alkaline phosphatase must not exceed twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL).
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- Use of any prescription medication within 1 month prior to dosing.
- Use of over-the-counter medications or vitamins within 14 days prior to dosing.
- Vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure, 90-<140 mm Hg, diastolic blood pressure, 60-<90 mm Hg, pulse rate, 50 - 100 beats per minute (bpm).
- Blood pressure and pulse will be taken again in a standing position. After at least 3 minutes standing, there shall be no more than a 20 mm Hg drop in systolic or 20 bpm increase in pulse rate associated with clinical manifestation of postural hypotension (Otherwise the subject will be classified as experiencing orthostatic hypotension)
- Group 2, 3, 4 (hepatic impairment)
- Clinically significant abnormal findings in physical examination, ECG or laboratory evaluations, not consistent with known clinical disease.
- Symptoms or history of Stage II or worse degree of encephalopathy within 6 months of study entry.
- Clinical evidence of severe ascites.
- History of surgical portosystemic shunt.
- Prothrombin time > 18 seconds.
- Any evidence of progressive liver disease (within the last 4 weeks) as indicated by liver transaminases, alkaline phosphatase, and GGT or a ≥ 50% worsening of serum bilirubin or prothrombin time.
- Evidence of drug or alcohol abuse within the last 6 months as indicated by laboratory assays conducted during screening or baseline evaluations.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
Official title: An Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics of 600 µg Indacaterol in Subjects With Impaired Hepatic Function in Comparison With Healthy Control Subjects
This study is designed to evaluate the safety and pharmacokinetic effects of indacaterol in subjects with impaired liver function in comparison with healthy subjects
- Conditions
- Hepatic Insufficiency
- Being tested
- QAB149
- Keywords
- safety study, pharmacokinetic effects, healthy subjects, hepatic impairment, liver, Subjects with mild and moderate hepatic impairment and healthy subjects
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAB149Drug
Also called indacaterol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | QAB149 Receives: Drug: QAB149 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessments of orally inhaled indacaterol will be made for up to 168 hours post dose for healthy subjects and for up to 240 hours post dose for patients with mild to moderate liver impairment.
Secondary outcomes (1)
General tolerability and safety indacaterol administered by oral inhalation in the study groups. Safety assessments will include physical examinations, ECGs, vital signs, adverse events, and laboratory evaluations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startNov 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416702
- Sponsor's protocol ID
- CQAB149A2307
- Status last verified
- Jun 2008
- First submitted
- 27 Dec 2006
- Last updated
- 10 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics of 600 µg Indacaterol in Subjects With Impaired Hepatic Function in Comparison With Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT00416702
- Acronym / sponsor ID
- CQAB149A2307
- Conditions
- Hepatic Insufficiency
- Keywords
- safety study, pharmacokinetic effects, healthy subjects, hepatic impairment, liver, Subjects with mild and moderate hepatic impairment and healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Mar 2008 (actual)
- First posted
- 28 Dec 2006 (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.
This study is designed to evaluate the safety and pharmacokinetic effects of indacaterol in subjects with impaired liver function in comparison with healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: QAB149QAB149 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- All Groups
- Male and/or female subjects in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Female subjects of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom or oral contraception.
- OR:
- Postmenopausal women must have no regular menstrual bleeding for at least 1 years prior to inclusion. Menopause will be confirmed by a plasma FSH level of >40 IU/L
Key exclusion criteria (25 listed)
- All Groups
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to study start.
- Significant illness within the 2 weeks prior to study start.
- A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
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 |
|---|---|---|
| QAB149Also: indacaterol | Drug | 1 |
Primary outcome
Pharmacokinetic assessments of orally inhaled indacaterol will be made for up to 168 hours post dose for healthy subjects and for up to 240 hours post dose for patients with mild to moderate liver impairment.
1 secondary outcome
General tolerability and safety indacaterol administered by oral inhalation in the study groups. Safety assessments will include physical examinations, ECGs, vital signs, adverse events, and laboratory evaluations.
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 10 Jun 2008.
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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.
Novartis principal investigator
Investigator site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QAB149 in people with Hepatic Insufficiency, run by Novartis at 1 site in United States.
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 20 inclusion and 25 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 10 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pharmacokinetic assessments of orally inhaled indacaterol will be made for up to 168 hours post dose for healthy subjects and for up to 240 hours post dose for patients with mild to moderate liver impairment.. 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 10 Jun 2008.