HealthyPhase 1NCT00409500
Effect of Food on the Pharmacokinetics of AQW051 in Japanese Healthy Male Subjects
A Phase 1 study testing AQW051 in people with Healthy, run by Novartis at 1 site in Japan.
Trial summary
This study will evaluate safety, tolerability and pharmacokinetics of individual oral doses of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the pharmacokinetics of AQW051. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AQW051
- How many people
- 54 participants
- Where
- 1 siteJapan
- Study dates
- Oct 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy male subjects age 20 to 45 years of age, and in good health
- At screening and baseline, the subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis.
- Body mass index within the range of 17 to 25 kg/m2 and weigh at least 50 kg
Who cannot join
- Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine 'high' level in checking by NicCheck® I.
- Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetaminophen is acceptable.
- Participation in any clinical investigation within 4 months prior to study start.
- Donation or loss of 400 mL or more of blood within 3 months; donation or loss of 200 mL or more of blood within 1 month; or donation of component blood within 2 weeks prior to study start.
- Subjects considered unsuitable for participation in the study within 2 weeks prior to dosing.
- A past medical history of clinically significant abnormality detected during electrocardiogram (ECG) examination or an evident family history (grandparents, parents and siblings) of a ECG abnormality (i.e. prolonged QT-interval syndrome).
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- History of fainting, hypotension when standing up, arrhythmia.
- History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- History of clinically significant drug allergy, history or presence of atopic allergy (asthma, urticaria, eczematous dermatitis) unless inactive seasonal allergy, or history of food allergy. 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.
- History of immunodeficiency diseases, including a positive HIV test result.
- A positive Hepatitis B surface antigen (HBsAg), Hepatitis C or Syphilis test result.
- History of drug or alcohol abuse within the 12 months prior to study participation or evidence of such abuse as indicated by the laboratory assays conducted at screening.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Interleaved, Ascending Dose Study, to Evaluate Safety, Tolerability and Pharmacokinetics of Single Oral Doses of AQW051; to Evaluate the Effect of Food on the Pharmacokinetics of AQW051, in Japanese Healthy Male Subjects
This study will evaluate safety, tolerability and pharmacokinetics of individual oral doses of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the pharmacokinetics of AQW051.
- Conditions
- Healthy
- Being tested
- AQW051
- Keywords
- Safety, tolerability, pharmacokinetics, AQW051, food, Japanese, healthy male subjects, Healthy volunteers study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQW051Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single oral doses of AQW051 in Japanese healthy male subjects at the end of the study
Secondary outcomes (2)
Pharmacokinetics of single oral doses of AQW051 in Japanese healthy male subjects at the end of the study
Effect of food on the pharmacokinetics of AQW051 after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
- Study startOct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 54 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Japan, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409500
- Sponsor's protocol ID
- CAQW051A1101
- Status last verified
- Jun 2007
- First submitted
- 8 Dec 2006
- Last updated
- 22 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Interleaved, Ascending Dose Study, to Evaluate Safety, Tolerability and Pharmacokinetics of Single Oral Doses of AQW051; to Evaluate the Effect of Food on the Pharmacokinetics of AQW051, in Japanese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00409500
- Acronym / sponsor ID
- CAQW051A1101
- Conditions
- Healthy
- Keywords
- Safety, tolerability, pharmacokinetics, AQW051, food, Japanese, healthy male subjects, Healthy volunteers study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 11 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 safety, tolerability and pharmacokinetics of individual oral doses of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the pharmacokinetics of AQW051.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Japanese healthy male subjects age 20 to 45 years of age, and in good health
- At screening and baseline, the subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis.
- Body mass index within the range of 17 to 25 kg/m2 and weigh at least 50 kg
Key exclusion criteria (14 listed)
- Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine 'high' level in checking by NicCheck® I.
- Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetaminophen is acceptable.
- Participation in any clinical investigation within 4 months prior to study start.
- Donation or loss of 400 mL or more of blood within 3 months; donation or loss of 200 mL or more of blood within 1 month; or donation of component blood within 2 weeks prior to study start.
- Subjects considered unsuitable for participation in the study within 2 weeks prior to dosing.
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 |
|---|---|---|
| AQW051 | Drug | – |
Primary outcome
Safety and tolerability of single oral doses of AQW051 in Japanese healthy male subjects at the end of the study
2 secondary outcomes
Pharmacokinetics of single oral doses of AQW051 in Japanese healthy male subjects at the end of the study
Effect of food on the pharmacokinetics of AQW051 after each dose
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 22 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 Japan 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 AQW051 in people with Healthy, run by Novartis at 1 site in Japan.
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 3 inclusion and 14 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 22 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 Japan. 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?
Safety and tolerability of single oral doses of AQW051 in Japanese healthy male subjects at the end of the study. 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 22 Jun 2007.