HealthyPhase 1NCT00410501
Evaluation of Pharmacokinetic Interaction of Indacaterol With Ketoconazole in Healthy Adult Subjects
A Phase 1 study testing Indacaterol (QAB149) in people with Healthy, run by Novartis at 1 site in India.
Trial summary
This study will evaluate the interaction potential between indacaterol and ketoconazole (a potent CYP3A inhibitor) in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Indacaterol (QAB149)
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2006to not given
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Indacaterol (QAB149)
- Keywords
- Pharmacokinetics, interaction, QAB149, indacaterol, ketoconazole, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indacaterol (QAB149)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startDec 2006
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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410501
- Sponsor's protocol ID
- CQAB149A2311
- Status last verified
- Jun 2007
- First submitted
- 12 Dec 2006
- Last updated
- 19 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00410501
- Acronym / sponsor ID
- CQAB149A2311
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, interaction, QAB149, indacaterol, ketoconazole, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- First posted
- 13 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 will evaluate the interaction potential between indacaterol and ketoconazole (a potent CYP3A inhibitor) in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Indacaterol (QAB149) | Drug | – |
Primary outcome
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
1 secondary outcome
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.
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 19 Jun 2007.
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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 study director
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 Indacaterol (QAB149) in people with Healthy, run by Novartis at 1 site in India.
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 4 inclusion and 16 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 19 Jun 2007. 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 India. 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?
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. 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 19 Jun 2007.