Phase 1 Pharmacodynamic StudyPhase 2NCT00803686
A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women
A Phase 2 study testing Oral rsCT tablet and Fortical (rsCT) nasal spray in people with Phase 1 Pharmacodynamic Study, run by Tarsa Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Phase 1 Pharmacodynamic Study
- What is being tested?
- Oral rsCT tablet and Fortical (rsCT) nasal spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, 65802
About this study
Official title: A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal Women
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.
Read the detailed description
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.
- Conditions
- Phase 1 Pharmacodynamic Study
- Being tested
- Oral rsCT tablet, Oral Placebo Tablet, Fortical (rsCT) nasal spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral rsCT tabletDrug
Also called rsCT
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.
Oral Placebo TabletDrug
Also called Placebo
Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.
Oral rsCT tabletDrug
Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.
Fortical (rsCT) nasal sprayDrug
Also called Fortical nasal spray
Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Double Blind Oral rsCT Tablet | Experimental | Intervention: Oral rsCT tablet given once 4 hours after evening meal. Receives: 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 Receives: Drug: Oral Placebo Tablet |
| Part 2 Open label, Oral rsCT tablet | Experimental | Intervention: Oral rsCT tablet given once 2 hours after evening meal. Receives: 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 Receives: Drug: Fortical (rsCT) nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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).
Measured: 12 hours
AUCInhibition=Hours*%P
The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve.
Measured: 12 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Phase 1 Pharmacodynamic StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsa Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Legg, D.O., Principal investigator, Bio-Kinetic Clinical Applications, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803686
- Sponsor's protocol ID
- UGL-OR0803
- Other IDs
- Bio-Kinetic No.: 13808
- Status last verified
- Jun 2014
- First submitted
- 4 Dec 2008
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00803686
- Acronym / sponsor ID
- UGL-OR0803
- Conditions
- Phase 1 Pharmacodynamic Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tarsa Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 Double Blind Oral rsCT Tablet | Experimental | Drug: Oral rsCT tabletIntervention: Oral rsCT tablet given once 4 hours after evening meal. |
| Part 1, Double-blind Oral Placebo Tablet | Placebo comparator | Drug: Oral Placebo TabletIntervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal |
| Part 2 Open label, Oral rsCT tablet | Experimental | Drug: Oral rsCT tabletIntervention: Oral rsCT tablet given once 2 hours after evening meal. |
| Part 2, Open Label Fortical Nasal Spray | Active comparator | Drug: Fortical (rsCT) nasal sprayIntervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral rsCT tabletAlso: rsCTOn 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. | Drug | Part 1 Double Blind Oral rsCT Tablet |
| Oral Placebo TabletAlso: PlaceboPart 1, Double blind oral placebo tablet given once 4 hours after evening meal. | Drug | Part 1, Double-blind Oral Placebo Tablet |
| Oral rsCT tabletPart 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal. | Drug | Part 2 Open label, Oral rsCT tablet |
| Fortical (rsCT) nasal sprayAlso: Fortical nasal sprayIntervention: Open label, Fortical nasal spray given once 2 hours after the evening meal. | Drug | Part 2, Open Label Fortical Nasal Spray |
Primary outcome
Pharmacodynamic Effect of Oral Calcitonin
Time frame: 12 hr
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
2 secondary outcomes
Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women
Time frame: 12 hours
AUCInhibition=Hours*%P
Time frame: 12 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Phase 1 Pharmacodynamic Study
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Legg, D.O. principal investigator
Bio-Kinetic Clinical Applications, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral rsCT tablet and Fortical (rsCT) nasal spray in people with Phase 1 Pharmacodynamic Study, run by Tarsa Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic Effect of Oral Calcitonin (time frame: 12 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.