Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women

Completed · Phase 1

Conditions studied: Healthy Postmenopausal Women

In brief

THAR2011-1 is a Phase I, single dose, open-label dose-escalation study to determine the safety, absolute bioavailability, dose proportionality, and pharmacokinetics of T121 in healthy postmenopausal women. The study is expected to identify a safe dose that can be further tested in subsequent multiple dose studies comparing the safety, PK and pharmacodynamics (PD) of T121 with the currently marketed IV zoledronic acid (Zometa).

Key facts

Study ID

NCT01721993

Run by

Thar Pharmaceuticals, Inc

People needed

71

Starts

2013-01-01

Expected to finish

2014-08-01

Last updated by the study team

2015-03-26

Who can join

Age: 35 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy, postmenopausal women between the ages of 35 and 70 years, inclusive. Postmenopausal females (based on medical history) defined as 12 continuous months of spontaneous amenorrhea or bilateral oophorectomy. Women 60 years of age and older will be considered postmenopausal. Women 35-59 must have a serum follicle-stimulating hormone (FSH) result consistent with postmenopausal state.
• Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lbs)
• Signed informed consent

You may not qualify if…

• • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• History of any severe allergic reaction or known allergy to ZA.
• Evidence or history of any gastrointestinal disease, such as irritable bowel syndrome, Crohn's Disease, chronic gastritis, peptic ulcer disease, H. pylori infection, or other gastrointestinal condition possibly affecting drug absorption.
• History of gastric surgery, including the Roux-en-Y gastric bypass surgery or an antrectomy with vagotomy, or gastrectomy.
• Evidence or history of any clinically significant cardiovascular (CV) disease or condition, including:
• Any history of a major CV event (myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack);
• Any history of a significant cardiac arrhythmia, implanted artificial pacemaker;
• Blood pressure greater than 150/90 and heart rate greater than 100 at screening;
• Clinically significant abnormalities on 12-lead ECG, including QTc >450 msec (heart-rate corrected using the Fridericia formula) at Screening.
• History of any autoimmune disease (e.g., systemic lupus erythematosus [SLE], scleroderma, psoriasis, vitiligo, primary biliary cirrhosis, etc.).
• Active/ongoing endocrine disorders (e.g., type 1 diabetes, adrenal insufficiency, hypoparathyroidism, etc.) except well controlled thyroid disease and type II diabetes with HgbA1C <8 are permitted.
• Mucolipidosis type IV.
• Any clinically significant hematological condition (e.g., pernicious anemia).
• Evidence or history of any other severe acute or chronic medical (including renal, pulmonary, hepatic, neurologic, psychiatric, etc.) disease or condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• History or evidence of Paget's disease of bone (osteitis deformans) or related disorder.
• A positive urine drug screen.
• A positive pregnancy test.
• History of difficulty swallowing large pills/tablets.
• Active dental or oral disease that would increase risk of bisphosphonate use and/or requires dental care.
• Prohibited substance use, including:
• Any documented history of drug or alcohol abuse within the previous 10 years;
• Chronic consumption over the past 12 months of more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine);
• Subject reported tobacco or nicotine use within 30 days of admission.
• Prohibited medication use, including:
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication, whichever is longer;

Where it is running

• Prism Clinical Research — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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