Trial record 3 of 5 for:    tarsa

A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00620854
First received: February 12, 2008
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).


Condition Intervention Phase
Osteoporosis
Drug: Recombinant Salmon Calcitonin (rsCT)
Drug: Oral Tablet
Drug: Nasal Spray
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Tarsa Therapeutics, Inc.:

Primary Outcome Measures:
  • Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB ] [ Designated as safety issue: No ]
    This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray.


Enrollment: 24
Study Start Date: February 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rsCTA
Oral Tablet
Drug: Oral Tablet
0.15 mgs recombinant salmon calcitonin, single oral dose
Experimental: rsCTB
Oral Tablet
Drug: Oral Tablet
0.2mgs recombinant salmon calcitonin, single oral tablet
Active Comparator: Fortical
Nasal Spray
Drug: Recombinant Salmon Calcitonin (rsCT)
Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.
Other Name: Fortical® nasal spray
Drug: Nasal Spray
200 IU recombinant salmon calcitonin, single intranasal spray

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal female, in good health (at least 5 years since last menses)
  • Age ≥45 and ≤70
  • Weight + or - 20% of the Metropolitan Life weight table
  • Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL
  • Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range
  • Willing and able to comply with all study requirements
  • Willing and able to sign written informed consent
  • Negative urine pregnancy test at screening
  • Negative Screen for Hepatitis B and C, human immunodeficiency virus (HIV) and drugs of abuse

Exclusion Criteria:

  • History of parathyroid, thyroid, pituitary or adrenal diseases
  • History of musculoskeletal disease
  • History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders
  • History of cancer within 5 years of enrollment other than basal cell carcinoma
  • History of regular use of non-steroidal anti-inflammatory drugs (NSAID)
  • History of surgery within 60 days of enrollment
  • History of hypersensitivity or allergies (other than seasonal allergies) within 5 years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications
  • Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study
  • Use of bisphosphonates within 6 months, selective selective estrogen receptor modulators (SERMS), estrogen or estrogen-like drugs 2 months, or calcitonin 1 month
  • Presence of any clinically significant illness
  • Unwilling or unable to comply with all study requirements
  • Unwilling or unable to sign written, informed consent
  • History of drug or alcohol abuse
  • Participation in any clinical study of an investigational drug within 60 days of enrollment
  • Plasma CTx-1 less than 0.25 ng/mL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620854

Locations
United States, Missouri
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Tarsa Therapeutics, Inc.
Investigators
Principal Investigator: Thomas Legg, D.O. Bio-Kinetic Clinical Applications, Inc.
  More Information

No publications provided

Responsible Party: Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00620854     History of Changes
Other Study ID Numbers: UGL-OR0702, Bio-Kinetic No.: 96508
Study First Received: February 12, 2008
Results First Received: April 22, 2009
Last Updated: January 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014