- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00410501
Evaluation of Pharmacokinetic Interaction of Indacaterol With Ketoconazole in Healthy Adult Subjects
June 18, 2007 updated by: Novartis
An Open Label, Single Dose, Two Period, Single Sequence Crossover Study to Assess the Pharmacokinetic Interaction of QAB149 (300 Mcg Via Inhalation) With Ketoconazole (200 mg Tablet b.i.d.) in Healthy Adult Subjects
This study will evaluate the interaction potential between indacaterol and ketoconazole (a potent CYP3A inhibitor) in healthy adult subjects.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mumbai, India
- Novartis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, male or female subjects of Indian origin age 18 to 45 years of age (inclusive)
- In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
- Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 2 years), or using a double-barrier local contraception if of childbearing potential
- Body mass index (BMI) within the range of 18.5 to 27 kg/m2 and weigh at least 45 kg for females and 50 kg for males
Exclusion Criteria:
- Smokers (use of tobacco products in the previous 3 months).
- Using or planning to use medications affecting GI (gastrointestinal) motility and/or perception (prokinetics, antidiarrheals, antispasmodics, anticholinergics, antacids containing magnesium or aluminum salts, erythromycin, octreotide, ondansetron or other 5-HT3 antagonists).
- Use of any prescription drugs within 4 weeks prior to dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two (2) weeks prior to dosing. Paracetamol (up to 4 g daily) is acceptable
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing or longer if required by local regulation.
- Significant illness within two weeks prior to dosing.
- A past medical history of clinically significant ECG abnormalities. Significant history of psychiatric disorder.
- History of clinically significantfainting, low blood pressure when standing, irregular heart beats or acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated) drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis, nasal polyp or NSAID (non-steroidal anti-inflammatory drug) induced urticaria)
- A known hypersensitivity or severe adverse event to indacaterol/ketoconazole or drugs similar to the study drugs.
- History of bowel obstruction, symptomatic gall bladder disease, suspected Sphincter of Oddi dysfunction, or abdominal adhesions.
- 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.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- Any planned surgery or procedure within 3 months of screening.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C or VDRL (Venereal Disease Research Laboratory) test result.
- History of drug or alcohol abuse within the 6 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations. Consumption of alcohol within 48 hours of receiving medication.
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pharmacokinetics of a single 300 µg dose of indacaterol (QAB149) alone administered via inhalation and in the presence of ketoconazole (at steady state) in healthy adult subjects
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Secondary Outcome Measures
Outcome Measure |
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Safety of a single 300 µg dose of indacaterol (QAB149) given via inhalation in the presence of ketoconazole at steady state in healthy adult subjects.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Novartis, Investigator site
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Study Registration Dates
First Submitted
December 12, 2006
First Submitted That Met QC Criteria
December 12, 2006
First Posted (Estimate)
December 13, 2006
Study Record Updates
Last Update Posted (Estimate)
June 19, 2007
Last Update Submitted That Met QC Criteria
June 18, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- CQAB149A2311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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