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

NCT00620854 | Completed Phase 2 Results

• 2 other identifiers: UGL-OR0702Bio-Kinetic No.: 96508
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)

  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.

  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

Study Arms (3)

rsCTA

EXPERIMENTAL

Oral Tablet

Drug: Oral Tablet

rsCTB

EXPERIMENTAL

Oral Tablet

Drug: Oral Tablet

Fortical

ACTIVE COMPARATOR

Nasal Spray

Drug: Recombinant Salmon Calcitonin (rsCT); Drug: Nasal Spray

Interventions

Nasal Spray DRUG

200 IU recombinant salmon calcitonin, single intranasal spray

Fortical

Recombinant Salmon Calcitonin (rsCT) DRUG

Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.

Also known as: Fortical® nasal spray

Fortical

Oral Tablet DRUG

0.15 mgs recombinant salmon calcitonin, single oral dose

rsCTA

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsa Therapeutics, Inc.: lead

Study Sites (1)

Bio-Kinetic Clinical Applications, Inc.

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

salmon calcitonin; Tablets; Nasal Sprays

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Aerosols; Colloids; Complex Mixtures

Results Point of Contact

• Title: Thomas Wicks, Ph.D., Vice-President Global RA/QA
• Organization: Tarsa Therapeutics, Inc.

twicks@tarsatherapeutics.com

267 273 7946

Study Officials

• Thomas Legg, D.O.

  Bio-Kinetic Clinical Applications, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 1, 2012
• Results First Posted: September 24, 2009

Record last verified: 2012-01

Locations

US (1)