Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and 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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01Fand T121E02F in Healthy Postmenopausal Women|
- PK parameters for a single dose of T121E01F, T121E02F or Zometa and assessment of dose proportionality for T121E01F [ Time Frame: 48 hours ] [ Designated as safety issue: No ]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).
- Safety and Tolerability of T121E01F and T121E02F [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Experimental: T121E01F||Drug: T121|
|Active Comparator: zoledronic acid IV||Drug: Zoledronic acid|
|United States, Minnesota|
|Prism Clinical Research||Recruiting|
|St. Paul, Minnesota, United States, 55114|
|Contact: Lynn Gill 651-641-2904 firstname.lastname@example.org|
|Principal Investigator:||Mark A Matson, MD||Prism Clinical Research|