OsteoporosisPhase 1NCT00499928
A Study To Investigate The Metabolism And Excretion Of 14C SB-751689 Given To Healthy Males And Postmenopausal Women
A Phase 1 study testing SB-751689 in people with Osteoporosis, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will examine the biological fate of radioactive SB-751689 administered to healthy males and healthy postmenopausal women. Subjects will receive a single oral dose of radioactive SB-751689. Excreta and blood samples will be taken over the course of 7 days. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- SB-751689
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 2007
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult males of age 35 to 65 years, inclusive, or healthy ambulatory postmenopausal women defined as being amenorrheic for at least 2 years and 40 to 65 years of age, inclusive, at screening with FSH levels consistent with menopause. Healthy postmenopausal women, who are between ages 40 to 50 years, inclusive, must also have a documented history of bilateral oophorectomy (with or without hysterectomy) and be at least 6 weeks post-surgery.)
- Non-smokers
- Body weight > or = 50 kg and BMI within the range 19 - 32 kg/m2
- A history of regular bowel movements
- 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
- QTc interval of > 450 msec at screening
- Positive urine drug screen at screening
- Positive urine test for alcohol at pre-dose
- Positive for HIV at screening
- Chronic hepatitis B and C, as evidenced by positive Hepatitis B surface antigen or Hepatitis C antibody
Show all 26Show fewer
- Urinary cotinine levels indicative of smoking at screening
- History of smoking or use of nicotine containing products within one year of the study or >10 pack-year history of smoking overall
- History of regular alcohol consumption exceeding 7 units/week for women and 14 units/week for men within 6 months of screening
- History of drug abuse within 6 months of the study
- Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug prior to the first dose of the current study medication
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Subjects who have received a total body radiation dose of greater than 5.0 mSv or exposure to significant radiation in the 12 months prior to this study
- Radiation exposure from the previous 3 year period is over 10 mSv for subjects who have been exposed to ionizing radiation above background as a result of their work with radiation as category A workers or as a result of research studies they may have been involved in. Clinical exposure will not be included
- Condition that could interfere with the accurate assessment and recovery of radiocarbon [14C]
- Use of prescription or nonprescription drugs including antacids, including vitamins, herbal and dietary supplements within 7 days prior to the first dose of study medication.
- Consumption of red wine, grapefruit, grapefruit juice or grapefruit-containing products 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 renal, hepatic or biliary impairment
- History of serious gastrointestinal disease or 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 or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- History of clinically significant cardiovascular disease
- History of pernicious anemia, pancreatitis, osteosarcoma or kidney stones.
- Conditions that might alter bone metabolism, including hyperparathyroidism, hypoparathyroidism, hyperthyroidism, hypothyroidism, Paget's disease, myeloma, malabsorption, or Cushing's syndrome, and hypogonadism (for male subjects), hypocalcemia, hypercalcemia, hypophosphatemia, hypomagnesemia, hypermagnesemia, osteopetrosis, osteomalacia, and recent history of fracture or prolonged bed rest
- Liver function tests, PTH, or CPK outside the reference range at screening
- Males unwilling to refrain from fathering a child during the study and for 14 days after
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Investigate the Excretion and Metabolic Disposition of a Single, Oral Dose of [14C]-SB-751689 (a Calcium-Sensing Receptor Antagonist) in Healthy Male Subjects and Healthy Postmenopausal Female Subjects
This study will examine the biological fate of radioactive SB-751689 administered to healthy males and healthy postmenopausal women. Subjects will receive a single oral dose of radioactive SB-751689. Excreta and blood samples will be taken over the course of 7 days. This study will help determine the major route of elimination of SB-751689 in humans. It will also provide samples (blood, plasma, urine, and stools) for analysis of metabolites, if any.
- Conditions
- Osteoporosis
- Being tested
- SB-751689
- Keywords
- SB-751689, osteoporosis, metabolism, excretion
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-751689Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of administered radioactivity recovered in excreta and the primary route of excretion over 7 days
Measured: over 7 days
Secondary outcomes (1)
The amount of radioactivity associated with blood vs. plasma. The total amount radioactivity vs. SB-751689 radioactivity (metabolite vs. parent) over 7 days
Measured: over 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2007
- Study completionJul 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, M.D., Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499928
- Sponsor's protocol ID
- CR9106327
- Status last verified
- May 2009
- First submitted
- 10 Jul 2007
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Investigate the Excretion and Metabolic Disposition of a Single, Oral Dose of [14C]-SB-751689 (a Calcium-Sensing Receptor Antagonist) in Healthy Male Subjects and Healthy Postmenopausal Female Subjects
- ClinicalTrials.gov ID
- NCT00499928
- Acronym / sponsor ID
- CR9106327
- Conditions
- Osteoporosis
- Keywords
- SB-751689, osteoporosis, metabolism, excretion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Jul 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.
This study will examine the biological fate of radioactive SB-751689 administered to healthy males and healthy postmenopausal women. Subjects will receive a single oral dose of radioactive SB-751689. Excreta and blood samples will be taken over the course of 7 days. This study will help determine the major route of elimination of SB-751689 in humans. It will also provide samples (blood, plasma, urine, and stools) for analysis of metabolites, if any.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult males of age 35 to 65 years, inclusive, or healthy ambulatory postmenopausal women defined as being amenorrheic for at least 2 years and 40 to 65 years of age, inclusive, at screening with FSH levels consistent with menopause. Healthy postmenopausal women, who are between ages 40 to 50 years, inclusive, must also have a documented history of bilateral oophorectomy (with or without hysterectomy) and be at least 6 weeks post-surgery.)
- Non-smokers
- Body weight > or = 50 kg and BMI within the range 19 - 32 kg/m2
- A history of regular bowel movements
- Capable of giving written informed consent
Key exclusion criteria (26 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
- QTc interval of > 450 msec at screening
- Positive urine drug screen at screening
- Positive urine test for alcohol at pre-dose
- Positive for HIV at screening
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 |
|---|---|---|
| SB-751689 | Drug | – |
Primary outcome
The total amount of administered radioactivity recovered in excreta and the primary route of excretion over 7 days
Time frame: over 7 days
1 secondary outcome
The amount of radioactivity associated with blood vs. plasma. The total amount radioactivity vs. SB-751689 radioactivity (metabolite vs. parent) over 7 days
Time frame: over 7 days
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 18 May 2009.
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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, M.D. study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB-751689 in people with Osteoporosis, run by GlaxoSmithKline 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 5 inclusion and 26 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 18 May 2009. 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. 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?
The total amount of administered radioactivity recovered in excreta and the primary route of excretion over 7 days (time frame: over 7 days). 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 18 May 2009.