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| ID | Type | Description | Link |
|---|---|---|---|
| Bio-Kinetic No.: 96508 |
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This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rsCTA | Experimental | Oral Tablet |
|
| rsCTB | Experimental | Oral Tablet |
|
| Fortical | Active Comparator | Nasal Spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Legg, D.O. | Bio-Kinetic Clinical Applications, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Kinetic Clinical Applications, Inc. | Springfield | Missouri | 65802 | United States |
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Subjects were recruited from the study site data base during January 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | rsCTA Then rsCTB Then Fortical | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| FG001 | rsCTA Then Fortical Then rsCTB | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| FG002 | rsCTB Then rsCTA Then Fortical | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| FG003 | rsCTB Then Fortical Then rsCTA | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| FG004 | Fortical Then rsCTA Then rsCTB | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| FG005 | Fortical Then rsCTB Then rsCTA | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout 1 |
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| Period 2 |
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| Washout 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | rsCTA Then rsCTB Then Fortical | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| BG001 | rsCTA Then Fortical Then rsCTB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per protocol, only subjects who completed all 3 treatments were analyzed. | Posted | Mean | Standard Error | % Change in Baseline CTx-1 | 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 |
|
Adverse Events were collected at each study visit. The three study periods occurred at weekly intervals, so the AE data were collected over a period of 3 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rsCTA Then rsCTB Then Fortical | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MeDRA 12.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Wicks, Ph.D., Vice-President Global RA/QA | Tarsa Therapeutics, Inc. | 267 273 7946 | twicks@tarsatherapeutics.com |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C028815 | salmon calcitonin |
| D013607 | Tablets |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D000336 | Aerosols |
| D003102 | Colloids |
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| Oral Tablet | Drug | 0.15 mgs recombinant salmon calcitonin, single oral dose |
|
| Oral Tablet | Drug | 0.2mgs recombinant salmon calcitonin, single oral tablet |
|
| Nasal Spray | Drug | 200 IU recombinant salmon calcitonin, single intranasal spray |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
| BG002 | rsCTB Then rsCTA Then Fortical | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| BG003 | rsCTB Then Fortical Then rsCTA | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| BG004 | Fortical Then rsCTA Then rsCTB | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| BG005 | Fortical Then rsCTB Then rsCTA | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Oral rsCT (200 micrograms) |
| OG002 | Fortical® | Fortical nasal spray (200 IU) |
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | rsCTA Then Fortical Then rsCTB | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 0 | 4 | 2 | 4 |
| EG002 | rsCTB Then rsCTA Then Fortical | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 0 | 4 | 1 | 4 |
| EG003 | rsCTB Then Fortical Then rsCTA | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 0 | 4 | 1 | 4 |
| EG004 | Fortical Then rsCTA Then rsCTB | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 0 | 4 | 3 | 4 |
| EG005 | Fortical Then rsCTB Then rsCTA | single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 0 | 4 | 3 | 4 |
| Headache | General disorders | MeDRA 12.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MeDRA 12.0 | Non-systematic Assessment |
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The disclosure restriction is that the Principal Investigator (PI) cannot without the sponsor's prior written consent, transmit, publish, or otherwise disclose to any person or entity either clinical trial results information.
| D009750 |
| Nutritional and Metabolic Diseases |
| D045424 |
| Complex Mixtures |