- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00410228
Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AHT956 in Healthy Subjects
June 21, 2007 updated by: Novartis
A Single Center, Randomized, Double-Blind, Placebo-and Positive-Controlled, Interleaved, Ascending Single Dose Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AHTT956 in Healthy Subjects
This study will evaluate the safety and tolerability of ascending single oral doses of AHT956 in healthy subjects
Study Overview
Study Type
Interventional
Enrollment
42
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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Bern, Switzerland
- Novartis Investigative Site
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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 and female subjects age 18 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Vital signs must be within the following ranges: oral body temperature between 35.0-37.5 °C; systolic blood pressure, 90-145 mm Hg; diastolic blood pressure, 50-95 mm Hg; pulse rate, 40-90 bpm
- Female subjects must either:have been surgically sterilized or hysterectomized at last 6 months prior to study participation with clinical documentation be postmenopausal (no regular menstrual bleeding for at least 1 year prior to study start)
- Body mass index must be within the range of 18 to 28 kg/m². Subjects must weigh at least 50 kg to participate in this study.
Exclusion Criteria:
- Smokers (any subject who uses tobacco or has cotinine greater than 500 ng/mL)).
- Subjects who received live vaccine 4 weeks prior to dosing, any prescription drug use with 4 weeks prior to dosing, or over-the-counter medication use within 2 weeks prior to dosing.
- 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.
- Flu-like symptoms or significant within two 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).
- History of fainting, hypotension when standing up, arrhythmia.
- History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- History of clinically significant drug allergy or history of atopic allergy, urticaria, eczematous dermatitis). A known hypersensitivity to the study drugs or drugs similar to the study drugs.
- Any history of surgical or medical condition(s) which could change the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject, including history of gastrointestinal, pancreatic, liver, kidney, bladder, blood, or immune systems.
- 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 the screening or baseline evaluations.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety, tolerability of ascending single doses of AHT956 in healthy subjects
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MTD (Maximum Tolerated Dose)
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Secondary Outcome Measures
Outcome Measure |
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Pharmacokinetics of single oral doses of AEB071
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Inhibition of T-cell function and lymphocytes proliferation following single rising oral of AHT956
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Pharmacokinetic/pharmacodynamic relationship of single rising oral doses of AHT956 at the end of study
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Identify gene expression patterns of blood cells
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2006
Study Registration Dates
First Submitted
December 11, 2006
First Submitted That Met QC Criteria
December 11, 2006
First Posted (Estimate)
December 12, 2006
Study Record Updates
Last Update Posted (Estimate)
June 22, 2007
Last Update Submitted That Met QC Criteria
June 21, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- CAHT956A2101
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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