Healthy Postmenopausal WomenPhase 1NCT01721993
Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women
A Phase 1 study testing T121 and Zoledronic acid in people with Healthy Postmenopausal Women, run by Thar Pharmaceuticals, Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Postmenopausal Women
- What is being tested?
- T121 and Zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2014
- 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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);
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- 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;
- Use of nonprescription drugs and dietary and/or vitamin supplements within 7 days prior to the first dose of study medication. Use of acetaminophen is acceptable for management of acute (e.g., pain) condition, as long as the daily dose is < 2000 mg and the duration does not exceed 3 consecutive days. The need for other new prescription or non-prescription drug(s) or supplements during the study should be discussed with the Medical Monitor;
- Prescription or herbal supplements within 14 days prior to the first dose of study medication;
- History of chronic proton pump inhibitor (PPI) use Proton pump inhibitors, H2 blockers, hormone replacement therapy, aminoglycosides, loop diuretics and nephrotoxic drugs within 30 days prior to the first dose of study medication;
- Bisphosphonate use within 90 days prior to the first dose of study medication;
- Use of a non-steroidal anti-inflammatory drug (NSAID) within 7 days prior to and 7 days after the administration of study medication;
- Use of acid reducer medication - including any antacid component, both non-prescription and prescription, within 7 days prior to and 1 day after the administration of study medication;
- Use of loop diuretics.
- A positive serology for Hepatitis B, Hepatitis C, HIV, or H. pylori. An indeterminate H. pylori result must be confirmed with an H. Pylori breath test. A positive result is exclusionary.
- Any invasive dental or oral procedure completed within 30 days prior to the first dose of study medication or anticipated during the study or within 30 days of completion of the study.
- Clinically significant abnormal laboratory test values, as determined by the Investigator, or any of the following:
- alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine 1.5 times above the upper limit of normal (ULN);
- platelets below the lower limit of normal;
- hemoglobin 10% below the lower level of normal;
- any out of normal range values for serum sodium, serum calcium, serum potassium or serum magnesium;
- Glomerular filtration rate (eGFR) < 60 mL/ minute as calculated by the modified Modification of Diet in Renal Disease (MDRD) formula.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prism Clinical Research
Saint Paul, Minnesota, 55114
About this study
Official title: Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01Fand T121E02F in Healthy Postmenopausal Women
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).
- Conditions
- Healthy Postmenopausal Women
- Being tested
- T121, Zoledronic acid
- Keywords
- oral zoledronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T121Drug
Zoledronic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| T121E01F | Experimental | Not described Receives: Drug: T121 |
| zoledronic acid IV | Active comparator | Not described Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters for a single dose of T121E01F, T121E02F or Zometa and assessment of dose proportionality for T121E01F
Pharmacokinetic parameters will include maximum serum concentration (Cmax), time corresponding to the occurrence of maximum serum concentration (tmax), area under the serum concentration-time curve from zero to the last observed quantifiable concentration (AUCtlast), area under the serum concentration-time curve from time zero to infinity (AUC), terminal exponential half-life (t1/2,z), absolute bioavailability, cumulative amount recovered in urine (Ae) and renal clearance (CLr).
Measured: 48 hours
Secondary outcomes (1)
Safety and Tolerability of T121E01F and T121E02F
Safety will be assessed by the number and severity of adverse events (AE) and changes in clinical laboratory safety parameters and vital signs from pre to post dose in each dose group. The frequency, severity and type of AEs between the dose groups will also be assessed. AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.03; June 14, 2010).
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Postmenopausal WomenStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thar Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark A Matson, MD, Principal investigator, Prism Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721993
- Sponsor's protocol ID
- THAR2011-1
- Status last verified
- Mar 2015
- First submitted
- 1 Nov 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01Fand T121E02F in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01721993
- Acronym / sponsor ID
- THAR2011-1
- Conditions
- Healthy Postmenopausal Women
- Keywords
- oral zoledronic acid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Thar Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Nov 2012 (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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T121E01F | Experimental | Drug: T121 |
| zoledronic acid IV | Active comparator | Drug: Zoledronic acid |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (40 listed)
- • 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:
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 |
|---|---|---|
| T121 | Drug | T121E01F |
| Zoledronic acid | Drug | zoledronic acid IV |
Primary outcome
PK parameters for a single dose of T121E01F, T121E02F or Zometa and assessment of dose proportionality for T121E01F
Time frame: 48 hours
Pharmacokinetic parameters will include maximum serum concentration (Cmax), time corresponding to the occurrence of maximum serum concentration (tmax), area under the serum concentration-time curve from zero to the last observed quantifiable concentration (AUCtlast), area under the serum concentration-time curve from time zero to infinity (AUC), terminal exponential half-life (t1/2,z), absolute bioavailability, cumulative amount recovered in urine (Ae) and renal clearance (CLr).
1 secondary outcome
Safety and Tolerability of T121E01F and T121E02F
Time frame: 7 Days
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 26 Mar 2015.
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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.
Mark A Matson, MD principal investigator
Prism Clinical Research
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 T121 and Zoledronic acid in people with Healthy Postmenopausal Women, run by Thar Pharmaceuticals, Inc 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 3 inclusion and 40 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 26 Mar 2015. 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. 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?
PK parameters for a single dose of T121E01F, T121E02F or Zometa and assessment of dose proportionality for T121E01F (time frame: 48 hours). 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 26 Mar 2015.