HealthyPhase 1NCT00417261

Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of Single and Multiple-Doses of ATF936 and AXT914 Administered Orally in Healthy Subjects.

A Phase 1 study testing ATF936 and AXT914 in people with Healthy, run by Novartis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 68 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ATF936 and AXT914
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 1 siteUnited States
Study dates: Nov 2006to Apr 2008
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 68 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:
Cessation of menses for ≥ 3 years.

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Documented total hysterectomy/bilateral oophorectomy at least 2 years prior to study participation.
Cessation of menses for < 25 years.
FSH level > 30 IU/L (confirmed prior to dosing).
All female subjects, regardless of age, must have negative pregnancy test results at screening and at each baseline.
At screening and initial baseline, Vital signs in supine position should be within the following ranges: 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)
Subjects must weigh at least 60 kg to participate in the study.
Body Mass Index:
Open-label safety cohort, Phases A and B: Subjects must have a body mass index (BMI) within the range of 18 to 28 kg/m2, inclusive (a BMI of up to 30 kg/m2 is permissible only if it can be demonstrated that recruitment is being hindered by having an upper limit of 28 kg/m2).
Phase C: Subjects must have a body mass index (BMI) strictly within the range of 18 to 28 kg/m2 (inclusive).
Vitamin D 25-(OH) serum level of ≥ 15 ng/ml (for subjects in Phase C at Screening only).
All Phases:
Normocalcemia - serum calcium ≥ 8.5 mg/dL and ≤ 10.2 mg/dL (or according to local lab ranges).

Who cannot join

All phases:
Smokers (use of tobacco products in the previous 3 months). Smokers will be defined who reports tobacco use and/or who has a urine cotinine ≥ 300 ng/ml.
Open-label safety cohort, Phases A and B:
Use of prescription and non-prescription medications:
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.

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Subjects who are using or have used within the last 2 months, any medicine in one or more of the following classes (Phase C only): An HMG coA reductase inhibitor ("statin"), a thiazide-type diuretic, an alpha adrenergic blocker, an anticonvulsant (for example, diphenylhydantoin, phenobarbital or carbamazepine) or a heparin class anticoagulant.
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:
Within the last 3 months: Estrogens, Hormone replacement therapy including Selective Estrogens Receptor Modulators (SERMs)
Within the last 12 months: Strontium ranelate, PTH, Calcitonin, Aluminum supplements
Within the last 24 months: Bisphosphonates (no bisphosphonate use permitted in last 24 months)
Subjects with a history of chronic use of systemic corticosteroids (oral or i.v.) within the last year where the total dose exceeds 750 mg of oral prednisone or equivalent. [NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articular) more than one month prior to screening are NOT exclusionary].
Subjects with cancer or history of malignancy of any organ system, treated or untreated, at any time, whether or not there is evidence of local recurrence or metastases. [NOTE - the following exceptions will apply: Basal cell or squamous cell carcinoma of the skin or colonic polyps with non-invasive malignancy that have been removed and not recurred, and carcinoma in-situ (CIS) of either the breast, cervix or uterus that has been surgically removed and has not recurred].
History or clinical evidence of abnormal thyroid function or thyroid disease (hypo-or-hyperthyroidism, TBG deficiency, etc.) or other endocrine disorders or conditions.
Subjects with bony deformities and/or neuromuscular irritability indicative of chronic hypocalcaemia.
Subjects with a history or evidence of previous/recent (within 6 months) fractures.
Participation in any clinical investigation within 4 weeks prior to initial 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 or plasma within 8 weeks prior to initial dosing, or longer if required by local regulation.
History or clinical evidence of any bleeding disorders (i.e., poor coagulation, prolonged clotting time, etc.) at Screening and/or initial Baseline.
Hemoglobin of < 12 g/dL at Screening and/or initial Baseline.
Significant illness within 2 weeks prior to initial dosing.
A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of prolonged QT-interval syndrome.
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, including bowel, gastrointestinal, renal, pulmonary, pancreatic, hepatic, hematological, immunological, or neurological disorder.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United States1 site

Novartis Investigative Site
East Hanover, New Jersey, 07936-1080

Other trials in United States

About this 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

Conditions: Healthy
Being tested: ATF936, AXT914
Keywords: ATF936, AXT914, healthy subjects, pharmacokinetics, parathyroid hormone, osteoporosis, Healthy male and female subjects
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ATF936Drug
AXT914Drug

Study groups in NCT00417261
Study group	Role	What they receive
1	Experimental	ATF936 Receives: Drug: ATF936
2	Experimental	AXT914 Receives: Drug: AXT914
3	Placebo comparator	Placebo Receives: Drug: ATF936; Drug: AXT914

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase A: Safety and tolerability of single, oral doses of ATF936 and AXT914 under proposed conditions in healthy male and female subjects. Pharmacokinetics (PK) and pharmacodynamics (PD) of ATF936 and AXT914 in healthy male and female subjects.
Phase B: A head-to-head comparison of ATF936 and AXT914, each given at its pharmacologically effective dose as determined in Phase A.
Phase C: Similarity of PK/PD profile to single-dose profile after limited multiple dosing in healthy post-menopausal females. Early bone biomarker information after multiple dosing for best candidate as selected in Phase A or Phase B

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Apr 2008

First posted29 Dec 2006 (estimated)
Study startNov 2006
Study completionApr 2008

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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00417261
Sponsor's protocol ID: CATF936A2201
Status last verified: Jun 2008
First submitted: 28 Dec 2006
Last updated: 23 Jun 2008
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00417261
Acronym / sponsor ID: CATF936A2201
Conditions: Healthy
Keywords: ATF936, AXT914, healthy subjects, pharmacokinetics, parathyroid hormone, osteoporosis, Healthy male and female subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (estimated)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Nov 2006
Study completion: Apr 2008 (actual)
First posted: 29 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: ATF936ATF936
2	Experimental	Drug: AXT914AXT914
3	Placebo comparator	Drug: ATF936, Drug: AXT914Placebo

Who may qualify

Ages: 18 to 68 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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.
Post menopausal status is established according to the following guidelines:
At screening and initial baseline, Vital signs in supine position should be within the following ranges: 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)
Subjects must weigh at least 60 kg to participate in the study.

Key exclusion criteria (25 listed)

Smokers (use of tobacco products in the previous 3 months). Smokers will be defined who reports tobacco use and/or who has a urine cotinine ≥ 300 ng/ml.
Use of prescription and non-prescription medications:
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.
Subjects who are using or have used within the last 2 months, any medicine in one or more of the following classes (Phase C only): An HMG coA reductase inhibitor ("statin"), a thiazide-type diuretic, an alpha adrenergic blocker, an anticonvulsant (for example, diphenylhydantoin, phenobarbital or carbamazepine) or a heparin class anticoagulant.

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
ATF936	Drug	1, 3
AXT914	Drug	2, 3

Primary outcome

Phase A: Safety and tolerability of single, oral doses of ATF936 and AXT914 under proposed conditions in healthy male and female subjects. Pharmacokinetics (PK) and pharmacodynamics (PD) of ATF936 and AXT914 in healthy male and female subjects.
Phase B: A head-to-head comparison of ATF936 and AXT914, each given at its pharmacologically effective dose as determined in Phase A.
Phase C: Similarity of PK/PD profile to single-dose profile after limited multiple dosing in healthy post-menopausal females. Early bone biomarker information after multiple dosing for best candidate as selected in Phase A or Phase B

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 23 Jun 2008.

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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 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 ATF936 and AXT914 in people with Healthy, run by Novartis at 1 site in United States.

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 18 inclusion and 25 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 23 Jun 2008. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Phase A: Safety and tolerability of single, oral doses of ATF936 and AXT914 under proposed conditions in healthy male and female subjects. Pharmacokinetics (PK) and pharmacodynamics (PD) of ATF936 and AXT914 in healthy male and female subjects.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00417261.

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 23 Jun 2008.