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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00417261 |
This is a first-in-human study and is designed to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic effects of a single and multiple-doses of ATF936 and AXT914 administered orally in healthy subjects.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: ATF936 Drug: AXT914 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Ascending Single and Multiple Dose, Seamless Design Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Orally Administered Compounds, ATF936 and AXT914, in Healthy Male and Female Subjects |
Estimated Enrollment: | 65 |
Study Start Date: | November 2006 |
Study Completion Date: | April 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
ATF936
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Drug: ATF936 |
2: Experimental
AXT914
|
Drug: AXT914 |
3: Placebo Comparator
Placebo
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Drug: ATF936 Drug: AXT914 |
Ages Eligible for Study: | 18 Years to 68 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Study population:
Open-label safety cohort, Phases A and B: Healthy male and female subjects between the ages 18 to 68 years (inclusive), in good health as determined by past medical history, physical examination, vital signs assessments, electrocardiograms, routine laboratory testing (hematology, biochemistry, urinalysis) and the opinion of the investigator at screening and baseline. Female subjects must be of non-childbearing potential who are either surgically sterilized or are post-menopausal (see inclusion criterion #2 below)
Phase C: Healthy post-menopausal females of up to and including 68 years of age, in good health as determined by past medical history, physical examination, vital signs assessments, electrocardiograms, routine laboratory testing (hematology, biochemistry, urinalysis) and the opinion of the investigator at screening and baseline.
All Phases:
Post menopausal status is established according to the following guidelines:
Oral body temperature: 35.0-37.5 °C (inclusive), Systolic blood pressure: 80 - 150 mm Hg (inclusive), Diastolic blood pressure: 50 - 90 mm Hg (inclusive), Pulse rate: 40 - 90 bpm (inclusive)
Body Mass Index:
All Phases:
Exclusion Criteria:
All phases:
Open-label safety cohort, Phases A and B:
Open-label safety cohort, Phases A and B: Use of any prescription drugs within 4 weeks prior to study start, and/or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements included) within 2 weeks prior to study start. If needed, acetaminophen is acceptable.
Phase C: Use of any prescription and/or non-prescription drugs (including vitamins, herbal supplements, and dietary supplements) within 4 weeks prior to study start, unless otherwise specified. If needed, acetaminophen is acceptable.
All Phases (pertaining primarily to post-menopausal females):
Subjects who are using or have used any medicine in one or more of the following classes:
Other protocol-defined inclusion/exclusion criteria may apply
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CATF936A2201 |
Study First Received: | December 28, 2006 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00417261 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ATF936, AXT914, healthy subjects, pharmacokinetics, parathyroid hormone, osteoporosis Healthy male and female subjects |
Osteoporosis Healthy Hormones |