OsteoporosisPhase 1NCT00554255
A Study of SB751689 in Japanese Postmenopausal Women
A Phase 1 study testing SB751689 in people with Osteoporosis, run by GlaxoSmithKline at 1 site.
Trial summary
To investigate the safety and tolerability, PK and PD of SB751689 following single and 5-day multiple oral doses of 100, 200, and 400 mg in Japanese postmenopausal subjects. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- SB751689
- How many people
- 18 participants
- Where
- 1 siteLocation not given
- Study dates
- 23 Oct 2006to 12 Dec 2006
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is considered as healthy by the investigator at screening.
- Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests
- Japanese healthy postmenopausal woman as defined as being amenorrheic for at least 1 year at screening with <157.79mIU/mL of FSH levels.
- Body weight >= 45 kg and BMI within the range 18.5 -25.0 kg/m2.
- The subject is within the following criteria as screening;Liver function tests (ALT, AST, GGT, alkaline phosphatase, total bilirubin), CPK, serum parathyroid hormone (iPTH) test, vitamin D (1,25(OH2 D3)) levels, Serum calcium
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Non-smokers (at least 6 months)
- The subject is able to attend all visits and complete the study.
Who cannot join
- The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
- History of sensitivity to any of the study medications or components thereof (except pollenosis without any signs or symptoms).
- Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication.
- Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.
- Positive for syphilis, HIV antibody, hepatitis B antigen or hepatitis C antibody, HTLV-1 antibody at screening.
- Positive urine drug screen at screening.
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- Donation of blood in excess of 400 mL within the previous 4 months or 200mL within the previous 1 month of screening.
- Use of prescription or non-prescription drugs, herbal and dietary supplements, within 14 days prior to the first dose of study medication.
- History of drug abuse or current conditions of drug abuse or alcoholism.
- History of regular alcohol consumption exceeding 7 units/week (>350mL of beer/unit) within 6 months of screening.
- Subjects with a history of renal, hepatic, or biliary disease.
- History of clinically significant cardiovascular disease.
- History of pernicious anemia, pancreatitis, osteosarcoma or kidney stones.
- Subjects who have had history of significant gastrointestinal disease (e.g., gastrointestinal malabsorptive disease, colostomy, chronic gastroesophageal reflux disease, Crohn's disease, ulcerative colitis, gastric or duodenal ulcer, gastrointestinal tract bleeding, short bowel syndrome, sprue, lactose intolerance, irritable bowel syndrome).
- Subjects with any history of a gastrointestinal surgical procedure that might affect the absorption of SB-751689 (e.g. cholecystectomy, gastrointestinal bypass surgery, partial or total gastrectomy, small bowel resection).
- Medical conditions which might alter bone metabolism, including hyperparathyroidism, hypoparathyroidism, hyperthyroidism, hypothyroidism, Paget's disease, malabsorption, or Cushing's syndrome, and hypogonadism, hypocalcemia, hypercalcemia, hypophosphatemia, hypomagnesemia, hypermagnesemia, osteopetrosis, osteomalacia, and recent (within one year) history of fracture or prolonged bedrest.
Trial locations and contacts
1 site in 1 country.
Location not given1 site
GSK Investigational Site
About this study
Official title: Phase I Study of SB751689 - Single and Multiple Oral Dose Study in Japanese Postmenopausal Women -
To investigate the safety and tolerability, PK and PD of SB751689 following single and 5-day multiple oral doses of 100, 200, and 400 mg in Japanese postmenopausal subjects.
- Conditions
- Osteoporosis
- Being tested
- SB751689
- Keywords
- Pharmacodynamics, Japanese, safety, Pharmacokinetics
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB751689Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, change in clinical laboratory tests, vital signs, 12lead ECG
Measured: throughout the study
Secondary outcomes (1)
Pharmacokinetics and Pharmacodynamics of SB751689
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study start23 Oct 2006
- Study completion12 Dec 2006
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554255
- Sponsor's protocol ID
- 108543
- Status last verified
- Aug 2018
- First submitted
- 2 Nov 2007
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of SB751689 - Single and Multiple Oral Dose Study in Japanese Postmenopausal Women -
- ClinicalTrials.gov ID
- NCT00554255
- Acronym / sponsor ID
- 108543
- Conditions
- Osteoporosis
- Keywords
- Pharmacodynamics, Japanese, safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2006
- Study completion
- 12 Dec 2006 (actual)
- First posted
- 6 Nov 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.
To investigate the safety and tolerability, PK and PD of SB751689 following single and 5-day multiple oral doses of 100, 200, and 400 mg in Japanese postmenopausal subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is considered as healthy by the investigator at screening.
- Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests
- Japanese healthy postmenopausal woman as defined as being amenorrheic for at least 1 year at screening with <157.79mIU/mL of FSH levels.
- Body weight >= 45 kg and BMI within the range 18.5 -25.0 kg/m2.
- The subject is within the following criteria as screening;Liver function tests (ALT, AST, GGT, alkaline phosphatase, total bilirubin), CPK, serum parathyroid hormone (iPTH) test, vitamin D (1,25(OH2 D3)) levels, Serum calcium
Key exclusion criteria (16 listed)
- The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
- History of sensitivity to any of the study medications or components thereof (except pollenosis without any signs or symptoms).
- Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication.
- Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.
- Positive for syphilis, HIV antibody, hepatitis B antigen or hepatitis C antibody, HTLV-1 antibody 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 |
|---|---|---|
| SB751689 | Drug | – |
Primary outcome
Adverse events, change in clinical laboratory tests, vital signs, 12lead ECG
Time frame: throughout the study
1 secondary outcome
Pharmacokinetics and Pharmacodynamics of SB751689
Time frame: throughout the study
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 29 Aug 2018.
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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 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 SB751689 in people with Osteoporosis, run by GlaxoSmithKline at 1 site.
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 8 inclusion and 16 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 29 Aug 2018. 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. 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?
Adverse events, change in clinical laboratory tests, vital signs, 12lead ECG (time frame: throughout the study). 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 29 Aug 2018.