OsteoporosisPhase 1NCT00468689
Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
A Phase 1 study testing SB-751689 oral tablets (100 and 400 ng) and Ketoconazole (NIZORAL) oral tablets (200 mg) in people with Osteoporosis, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- SB-751689 oral tablets (100 and 400 ng) and Ketoconazole (NIZORAL) oral tablets (200 mg)
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Aug 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-60yrs, with BMI of 19-31kg/m2.
- Females must be of non-childbearing potential.
- Subjects must be able to give consent and comply with restrictions of study.
Who cannot join
- Clinically relevant abnormality from history, physical, 12-lead ECG, Holter monitoring, or clinical laboratory examination.
- Positive urine drug screen.
- Positive urine test for alcohol.
- Contine levels indicative of smoking.
- Positive HIV or Hep B and/or C assay.
- History or smoking in last year or >10 pack/year history of smoking overall.
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- History of regular alcohol consumption (7 units/week for women and 14 units/week for men) within 6 months of study.
- History of drug abuse within 6 months of study.
- Participation in another drug trial within 30 days of first dose.
- Exposure to more than 4 new chemical entities within 12 months of first dose.
- Use of prescription and non-prescription drugs including dietary supplements, herbals and St. John's wort within 14 days of first dose.
- Consumption of red wine, grapefruit, grapefruit juice and grapefruit products within 14 days of first dose.
- Donation of blood in excess of 500 mL within 56 days of dosing.
- Evidence of renal, hepatic or biliary impairment.
- History of serious gastrointestinal disease or history of gastrointestinal surgical procedure that might affect absorption of study drug.
- History of sensitivity to any of the study medications.
- History of clinically significant cardiovascular disease.
- History of pernicious anemia, pancreatitis, osteosarcoma or kidney stones. Medical conditions which might alter bone metabolism.
- Liver function tests above ULN at screening and PTH, glucose, and CPK outside the reference range at screening.
- Males unwilling to refrain from fathering a child during the study and for 14 days following the last dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-751689 When Administered as an Oral Formulation at Supratherapeutic Dose Levels in Healthy Adult Subjects.
This study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.
- Conditions
- Osteoporosis
- Being tested
- SB-751689 oral tablets (100 and 400 ng), Ketoconazole (NIZORAL) oral tablets (200 mg)
- Keywords
- SB-751689,, Calcium-sensing receptor antagonist (CaR),, Osteoporosis,, Parathyroid hormone (PTH),, Oral dose
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-751689 oral tablets (100 and 400 ng)Drug
Ketoconazole (NIZORAL) oral tablets (200 mg)Drug
Also called SB-751689 oral tablets (100 and 400 ng)
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SB-751689 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests
Measured: throughout the study
Secondary outcomes (1)
PK and of SB-751689 as determined by AUC, Cmax, tmax, and half-life. PD effects (PTH, serum Ca) as determined by AUC, Emax, tmax, maximum change and % change from baseline, duration of effect, duration above ULN for PTH.
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 posted3 May 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2007
- Study completionAug 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 15 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
- NCT00468689
- Sponsor's protocol ID
- CR9107262
- Status last verified
- Oct 2008
- First submitted
- 1 May 2007
- Last updated
- 13 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-751689 When Administered as an Oral Formulation at Supratherapeutic Dose Levels in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT00468689
- Acronym / sponsor ID
- CR9107262
- Conditions
- Osteoporosis
- Keywords
- SB-751689,, Calcium-sensing receptor antagonist (CaR),, Osteoporosis,, Parathyroid hormone (PTH),, Oral dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 3 May 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 evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 18-60yrs, with BMI of 19-31kg/m2.
- Females must be of non-childbearing potential.
- Subjects must be able to give consent and comply with restrictions of study.
Key exclusion criteria (20 listed)
- Clinically relevant abnormality from history, physical, 12-lead ECG, Holter monitoring, or clinical laboratory examination.
- Positive urine drug screen.
- Positive urine test for alcohol.
- Contine levels indicative of smoking.
- Positive HIV or Hep B and/or C assay.
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 oral tablets (100 and 400 ng) | Drug | – |
| Ketoconazole (NIZORAL) oral tablets (200 mg)Also: SB-751689 oral tablets (100 and 400 ng) | Drug | – |
Primary outcome
Safety and tolerability of SB-751689 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests
Time frame: throughout the study
1 secondary outcome
PK and of SB-751689 as determined by AUC, Cmax, tmax, and half-life. PD effects (PTH, serum Ca) as determined by AUC, Emax, tmax, maximum change and % change from baseline, duration of effect, duration above ULN for PTH.
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 13 Oct 2008.
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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
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 oral tablets (100 and 400 ng) and Ketoconazole (NIZORAL) oral tablets (200 mg) 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 3 inclusion and 20 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 13 Oct 2008. 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?
Safety and tolerability of SB-751689 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests (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 13 Oct 2008.