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| ID | Type | Description | Link |
|---|---|---|---|
| Bio-Kinetic No.: 13808 | Other Identifier | Unigene Laboratories 0803 |
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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.
Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Double Blind Oral rsCT Tablet | Experimental | Intervention: Oral rsCT tablet given once 4 hours after evening meal. |
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| 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 |
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| Part 2 Open label, Oral rsCT tablet | Experimental | Intervention: Oral rsCT tablet given once 2 hours after evening meal. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women | See Primary Outcome description. These CTx-1 plasma concentrations were collected over 12 hours, the values seen following active were compared with the time-matched individual values following placebo and used to derive the pharmacodynamic parameters. The primary was Rmin, seen above, and the Secondary ones were the time to that Rmin (Tmin) and the total time from the beginning of the inhibition to the end of the effect or the end of the study period (Tinhibition). |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Recombinant Salmon Calcitonin (rsCT) | In Part 1, Period 1, 6 Subjects each were given rsCT tablets or 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral placebo 4 hours after the evening meal. |
| FG001 | Oral Placebo | In Part 1, Period 1, 6 Subjects each were given oral placebo tablets 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral rsCT tablets 4 hours after the evening meal. |
| FG002 | Oral rsCT Tablets (Part 2, Period 3) | After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter open label Part 2, Period 3, and received oral rsCT tablets given 2 hours after the evening meal. |
| FG003 | Fortical Nasal Spray (Part 2, Period 3) | After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter the open label Part 2, Period 3 and were given Fortical Nasal Spray 2 hours after the evening meal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1, Period 1 |
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| Part 1, Period 2 |
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| Part 2, Period 3 |
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Only 12 women entered Part 1, the two-period crossover portion of the study; hence the same 12 received both oral treatments and should not be counted twice. Only 9 of those 12 went on to Part 2, the open label, non-crossover portion of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 Oral rsCT Tablets | Subjects were given oral rsCT tablets 4 hours after the evening meal |
| BG001 | Part 1 Oral Placebo Tablets | Subjects were given oral placebo tablets 4 hours after the evening meal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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 | Not applicable. All participants who received treatment were included. | Posted | Mean | Standard Deviation | percentage of time-matched placebo respo | 12 hr |
Any time within the treatment period up to 30 days after treatment
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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 | Part 1 Oral rsCT Tablets | Subjects were given oral rsCT tablets 4 hours after the evening meal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedRRA 12.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas LaBella, Jr. Vice-President Global RA/QA | Tarsa Therapeutics, Inc | 267-273-7944 | nlabella@tarsatherapeutics.com |
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| ID | Term |
|---|---|
| C028815 | salmon calcitonin |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 |
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| Oral Placebo Tablet | Drug | Part 1, Double blind oral placebo tablet given once 4 hours after evening meal. |
|
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| Oral rsCT tablet | Drug | Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal. |
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| Fortical (rsCT) nasal spray | Drug | Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal. |
|
|
| 12 hours |
| AUCInhibition=Hours*%P | The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve. | 12 Hours |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Part 2 Open Label--Oral rsCT Tablets | After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal. |
| BG003 | Part 2 Open Label Fortical Intranasal Spray | After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal |
| BG004 | Total | Total of all reporting groups |
| years |
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| Gender | Number | participants |
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| Region of Enrollment | Number | participants |
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| post-menopausal healthy females | Number | participants |
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| post-menopausal females | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Part 1 Oral rsCT Tablets | In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal. |
| OG001 | Part 1 Oral Placebo Tablets | In this arm, subjects were given oral placebo tablets 4 hours after the evening meal. |
| OG002 | Part 2 Oral rsCT Tablets | Subjects were given oral rsCT tablets four hours after the evening meal |
| OG003 | Part 2 Fortical Intra-nasal Spray | Subjects were given Fortical (rsCT) nasal spray four hours after the evening meal |
|
|
| Secondary | Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women | See Primary Outcome description. These CTx-1 plasma concentrations were collected over 12 hours, the values seen following active were compared with the time-matched individual values following placebo and used to derive the pharmacodynamic parameters. The primary was Rmin, seen above, and the Secondary ones were the time to that Rmin (Tmin) and the total time from the beginning of the inhibition to the end of the effect or the end of the study period (Tinhibition). | Data from Part 1 (crossover Periods 1 and 2) were pooled to give CTx-1 mean data for the oral rsCT tablet group (n = 12) and for the oral placebo group n = 12). Part 2, open-label, non-crossover, compared the CTx-1 results after oral rsCT (n = 5) with those after Fortical(n = 4. The % inhibition is reported first. | Posted | Mean | Standard Deviation | Hours | 12 hours |
|
|
|
| Secondary | AUCInhibition=Hours*%P | The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve. | Posted | Mean | Standard Deviation | hours*%P | 12 Hours |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Part 1 Oral Placebo Tablets | Subjects were given oral placebo tablets 4 hours after the evening meal. | 0 | 12 | 3 | 12 |
| EG002 | Part 2 Open Label--Oral rsCT Tablets | After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal. | 0 | 5 | 0 | 5 |
| EG003 | Part 2 Open Label Fortical Intranasal Spray | After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal | 0 | 4 | 1 | 4 |
| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| eyelid edema | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Pharmaceutical Preparations |
| TInhibition=total time of effect in hours |
|