Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women
Public ClinicalTrials.gov record NCT01721993. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01Fand T121E02F in Healthy Postmenopausal Women
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01721993
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 71 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 35 Years to 70 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2012
- Primary completion
- Jun 30, 2014
- Completion
- Jul 31, 2014
- Last update posted
- Mar 25, 2015
2013 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Prism Clinical Research | Saint Paul | Minnesota | 55114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01721993, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 25, 2015 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01721993 live on ClinicalTrials.gov.