Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00416702
Other study ID # CQAB149A2307
Secondary ID
Status Completed
Phase Phase 1
First received December 27, 2006
Last updated June 9, 2008
Start date November 2006
Est. completion date March 2008

Study information

Verified date June 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date March 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

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:

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).

Exclusion Criteria:

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

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
QAB149


Locations

Country Name City State
United States Novartis Investigative Site East Hanover New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
See also
  Status Clinical Trial Phase
Completed NCT04097704 - Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
Completed NCT02161224 - A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function Phase 1
Completed NCT00929032 - Liver Transplantation and Reticuloendothelial Clearance Capacity N/A
Completed NCT00509210 - Study of Telaprevir in Subjects With Hepatic Impairment Phase 1
Completed NCT02894385 - Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201) Phase 1
Completed NCT03306667 - Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency) Phase 1
Completed NCT04867941 - A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196 Phase 1
Terminated NCT02457702 - Mitochondrial Function in Patients With Severe Liver Disease N/A
Completed NCT02090621 - Extracorporeal Photopheresis After Liver Transplant Phase 2
Completed NCT02249442 - Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency Phase 1
Completed NCT03341884 - A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants Phase 1
Completed NCT01475136 - A Study of LY2140023 in Hepatically-Impaired Participants Phase 1
Completed NCT00968591 - Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency Phase 1
Completed NCT00969813 - A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function Phase 1
Completed NCT00931060 - Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects N/A
Completed NCT03968848 - Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite Phase 1
Completed NCT00692341 - Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics Phase 1
Completed NCT00314054 - Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults Phase 1
Completed NCT05731895 - A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems Phase 1
Completed NCT03842761 - A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems Phase 1