Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function

NCT00416702 | Completed Phase 1

• 1 other identifier: CQAB149A2307
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hepatic Insufficiency

Keywords

safety study, pharmacokinetic effects, healthy subjects, hepatic impairment, liver; Subjects with mild and moderate hepatic impairment and healthy subjects

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

1

EXPERIMENTAL

QAB149

Drug: QAB149

Interventions

QAB149 DRUG

Also known as: indacaterol

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: November 1, 2006
• Study Completion: March 1, 2008
• Last Updated: June 10, 2008

Record last verified: 2008-06

Locations

US (1)