OsteoporosisPhase 1NCT00532077
A Study to Evaluate the Effects of SB-751689 or rhPTH(1-34) on Excretion of Calcium and Phosphate in Women
A Phase 1 study testing rhPTH(1-34), SB-751689 100 mg and SB-751689 400 mg in people with Osteoporosis, run by GlaxoSmithKline at 5 sites in United States.
Trial summary
SB-751689 may alter calcium and phosphate handling at the kidney level. This study will examine what happens to calcium and phosphate, and other electrolytes, at the kidney after treatment with SB-751689 for 1 month. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- rhPTH(1-34), SB-751689 100 mg and SB-751689 400 mg
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2007to Jan 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy postmenopausal women 40 to 65 years of age, inclusive, meeting at least one of the following: Postmenopausal defined by the STRAW criteria of 12 months of spontaneous amenorrhea with serum FSH levels = 40 mIU/mL; History of bilateral oophorectomy (with or without hysterectomy) and at least 6 weeks post-surgical with serum FSH levels = 40 mIU/mL
- Body weight > 50 kg and BMI within the range 19 - 32 kg/m2
- Capable of giving written informed consent
Who cannot join
- Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study. These abnormalities may be identified on the screening history and physical or laboratory examination and 12-lead electrocardiogram (ECG).
- A subject may not participate in the study if any of the following laboratory results are above the upper limit of the normal range at screening: liver function tests (ALT, AST, GGT, alkaline phosphatase, total bilirubin), plasma amylase, glucose, alkaline phosphatase, or CPK.
- A subject may not participate in the study if any of the following laboratory results are outside the normal range at screening: serum levels of albumin-adjusted calcium, total calcium, PTH, and urinary calcium.
- A subject with vitamin D deficiency as defined by serum 25-hydroxy vitamin D < 20 ng/mL (equivalent to 50 nmol/L) at screening may not participate in the study. A QTc interval > 450 msec at screening.
- Positive urine drug screen.
- Positive for HIV, hepatitis B virus or hepatitis C virus assays.
Show all 30Show fewer
- Urinary cotinine levels indicative of smoking.
- History of smoking or use of nicotine containing products within one year of screening.
- History of regular alcohol consumption
- History of drug abuse within 6 months of the study.
- Participation in a study with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, calcium containing antacids, aspirin or nonsteroidal anti-inflammatory drugs, vitamins, herbal and dietary supplements, excluding study related vitamin D and calcium supplements, within 14 days prior to the first dose of study medication.
- Donation of blood in excess of 500 mL within 56 days prior to dosing.
- Evidence of hepatic or biliary disease (including cholecystectomy and Gilbert's Syndrome).
- Significant renal disease as define by:
- Serum creatinine clearance <60ml/min (estimated from serum creatinine (SCr) and demographic data using the MDRD calculation):
- A validated web-based calculator is found at: http://nephron.com/cgi-bin/MDRDSIdefault.cgi
- GFR Calculator
- To calculate estimated GFR (mL/min/1.73m2) manually:
- = 186 x (SCr in mg/dL)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if African-American)
- = exp(5.228-1.154 x ln (SCr)-0.203x ln(age)-(0.299 if female) + (0.192 if African American))
- Urine protein/creatinine (mg/mg) ratio >2.5; or urine albumin concentration > 300 ug/mg.
- Known loss of kidney, either surgically or by injury or disease
- History of significant gastrointestinal
- History of a gastrointestinal surgical procedure that might affect the absorption of SB-751689
- History of sensitivity to any of the study medications or components thereof.
- History of clinically significant cardiovascular disease.
- History of pancreatitis or kidney stones. Medical conditions which might alter bone metabolism
- Subjects at increased risk of osteosarcoma such as those with Paget's disease of the bone or any prior external beam or implant radiation therapy involving the skeleton.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
GSK Investigational Site
Austin, Texas, 78752
GSK Investigational Site
Daytona Beach, Florida, 32117
GSK Investigational Site
Honolulu, Hawaii, 96813
GSK Investigational Site
Port Orange, Florida, 32127
GSK Investigational Site
San Diego, California, 92123
About this study
Official title: An Exploratory, Open Label, Multicenter Parallel Group Study to Evaluate the Effects of Single and Repeat Dosing of SB-751689 (400 mg or 100 mg) or rhPTH(1-34) on the Fractional Renal Excretion of Calcium and Phosphate in Healthy Postmenopausal Females.
SB-751689 may alter calcium and phosphate handling at the kidney level. This study will examine what happens to calcium and phosphate, and other electrolytes, at the kidney after treatment with SB-751689 for 1 month. Another group of subjects will get another drug called Forteo for 1 month to compare the response of the kidney for calcium and phosphate.
- Conditions
- Osteoporosis
- Being tested
- rhPTH(1-34), SB-751689 100 mg, SB-751689 400 mg
- Keywords
- renal,, pharmacology,, Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhPTH(1-34)Drug
SB-751689 100 mgDrug
SB-751689 400 mgDrug
Also called rhPTH(1-34), SB-751689 100 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
renal fractional clearance of calcium and phosphate
Measured: over 1 month
Secondary outcomes (7)
renal fraction clearance of electrolytes, cAMP, safety measures, and serum biomarkers
Measured: over 1 month
urinary excretion of sodium, magnesium, potassium, bicarbonate, and chloride
Albumin-adjusted serum calcium levels
Vitamin D and P1NP levels
Plasma levels of SB-751689 and rhPTH(1-34)
Plasma PTH
Adverse event reports, 12-lead ECGs, vital signs, nursing/physician observation and laboratory tests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532077
- Sponsor's protocol ID
- CR9108122
- Status last verified
- Oct 2010
- First submitted
- 17 Sep 2007
- Last updated
- 19 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open Label, Multicenter Parallel Group Study to Evaluate the Effects of Single and Repeat Dosing of SB-751689 (400 mg or 100 mg) or rhPTH(1-34) on the Fractional Renal Excretion of Calcium and Phosphate in Healthy Postmenopausal Females.
- ClinicalTrials.gov ID
- NCT00532077
- Acronym / sponsor ID
- CR9108122
- Conditions
- Osteoporosis
- Keywords
- renal,, pharmacology,, Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SB-751689 may alter calcium and phosphate handling at the kidney level. This study will examine what happens to calcium and phosphate, and other electrolytes, at the kidney after treatment with SB-751689 for 1 month. Another group of subjects will get another drug called Forteo for 1 month to compare the response of the kidney for calcium and phosphate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy postmenopausal women 40 to 65 years of age, inclusive, meeting at least one of the following: Postmenopausal defined by the STRAW criteria of 12 months of spontaneous amenorrhea with serum FSH levels = 40 mIU/mL; History of bilateral oophorectomy (with or without hysterectomy) and at least 6 weeks post-surgical with serum FSH levels = 40 mIU/mL
- Body weight > 50 kg and BMI within the range 19 - 32 kg/m2
- Capable of giving written informed consent
Key exclusion criteria (30 listed)
- Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study. These abnormalities may be identified on the screening history and physical or laboratory examination and 12-lead electrocardiogram (ECG).
- A subject may not participate in the study if any of the following laboratory results are above the upper limit of the normal range at screening: liver function tests (ALT, AST, GGT, alkaline phosphatase, total bilirubin), plasma amylase, glucose, alkaline phosphatase, or CPK.
- A subject may not participate in the study if any of the following laboratory results are outside the normal range at screening: serum levels of albumin-adjusted calcium, total calcium, PTH, and urinary calcium.
- A subject with vitamin D deficiency as defined by serum 25-hydroxy vitamin D < 20 ng/mL (equivalent to 50 nmol/L) at screening may not participate in the study. A QTc interval > 450 msec at screening.
- Positive urine drug screen.
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 |
|---|---|---|
| rhPTH(1-34) | Drug | – |
| SB-751689 100 mg | Drug | – |
| SB-751689 400 mgAlso: rhPTH(1-34), SB-751689 100 mg | Drug | – |
Primary outcome
renal fractional clearance of calcium and phosphate
Time frame: over 1 month
7 secondary outcomes
renal fraction clearance of electrolytes, cAMP, safety measures, and serum biomarkers
Time frame: over 1 month
urinary excretion of sodium, magnesium, potassium, bicarbonate, and chloride
Albumin-adjusted serum calcium levels
Vitamin D and P1NP levels
Plasma levels of SB-751689 and rhPTH(1-34)
Plasma PTH
Adverse event reports, 12-lead ECGs, vital signs, nursing/physician observation and laboratory tests.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rhPTH(1-34), SB-751689 100 mg and SB-751689 400 mg in people with Osteoporosis, run by GlaxoSmithKline at 5 sites 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 3 inclusion and 30 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 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
renal fractional clearance of calcium and phosphate (time frame: over 1 month). 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 19 Oct 2010.