A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women

NCT00803686 | Completed Phase 2 Results

• 2 other identifiers: UGL-OR0803Bio-Kinetic No.: 13808
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.

Conditions

Phase 1 Pharmacodynamic Study

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamic Effect of Oral Calcitonin

  C-terminal telopeptide of Collagen Type I (CTx-1) is an established plasma biomarker employed as an index of bone-resorption activity in response to interventions such as an anti-resorptive agent such as calcitonin. Here the calcitonin-salmon is rsCT, (recombinant) both oral and intranasal. These CTx-1 plasma concentrations were collected over 12 hours post-dosing where each subject served as her own control, as all received placebo in this crossover study, to account for the known diurnal variation of plasma CTx-1. For each time point, the ratio of the calcitonin response over the placebo response for that subject was derived from the plasma levels of CTx-1 and reported as a % of the placebo response (% Placebo or %P). These values were used to determine the primary pharmacodynamic parameter of Rmin, the minimum value seen following each active dose. The same %P values were used to derive the secondary pharmacodynamic parameters described in Secondary outc

  12 hr

Secondary Outcomes (2)

• Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women

  12 hours

• AUCInhibition=Hours*%P

  12 Hours

Study Arms (4)

Part 1 Double Blind Oral rsCT Tablet

EXPERIMENTAL

Intervention: Oral rsCT tablet given once 4 hours after evening meal.

Drug: Oral rsCT tablet

Part 1, Double-blind Oral Placebo Tablet

PLACEBO COMPARATOR

Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal

Drug: Oral Placebo Tablet

Part 2 Open label, Oral rsCT tablet

EXPERIMENTAL

Intervention: Oral rsCT tablet given once 2 hours after evening meal.

Drug: Oral rsCT tablet

Part 2, Open Label Fortical Nasal Spray

ACTIVE COMPARATOR

Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal

Drug: Fortical (rsCT) nasal spray

Interventions

Oral rsCT tablet DRUG

On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description.

Also known as: rsCT

Part 1 Double Blind Oral rsCT Tablet

Oral Placebo Tablet DRUG

Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.

Also known as: Placebo

Part 1, Double-blind Oral Placebo Tablet

Fortical (rsCT) nasal spray DRUG

Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.

Also known as: Fortical nasal spray

Part 2, Open Label Fortical Nasal Spray

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 five years since last menses).
• Age greater than or equal to 45 years old and less than or equal to 70 years old
• Weight ± 20% of the Metropolitan Life weight table.
• Plasma CTx-1 greater than or equal to 0.25 ng/ml.
• Total calcium, phosphorus, and magnesium 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, 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 a Non-Steroidal Anti-inflammatory Drug (NSAID).
• History of surgery within 60 days of enrollment.
• History of hypersensitivity or allergies (other than seasonal allergies) within -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, 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

Interventions

salmon calcitonin; Nasal Sprays

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nicholas LaBella, Jr. Vice-President Global RA/QA
• Organization: Tarsa Therapeutics, Inc

nlabella@tarsatherapeutics.com

267-273-7944

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-06

Locations

US (1)