OsteoporosisPhase 1NCT00651534
To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females
A Phase 1 study testing Ronacaleret in people with Osteoporosis, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Ronacaleret
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to not given
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy postmenopausal women
- Non-smokers
- Body weight > or = 50 kg and BMI within the range 19-32 kg/m2
- Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
- Hispanic or non-Hispanic (Caucasian) ethnicity
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
- Positive urine drug screen at screening
- Positive urine test for alcohol at pre-dose
- Positive for HIV or hepatitis B or C virus at screening
- 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
Show all 20Show fewer
- History of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) 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 (whichever is longer) 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.
- Use of prescription or non-prescription drugs
- 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
- 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
- Medical conditions that might alter bone metabolism
- Serum parathyroid hormone (iPTH) test levels outside the reference range at screening
- Liver function tests, parathyroid hormone test or CPK outside the reference range at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Port Orange, Florida, 32127
About this study
Official title: An Open-label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400 mg Ronacaleret (a Calcium-sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females.
This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.
- Conditions
- Osteoporosis
- Being tested
- Ronacaleret
- Keywords
- Formulation Drug Study, healthy postmenopausal
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RonacaleretDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startFeb 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
- Enrolment
- 32 participants
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
- NCT00651534
- Sponsor's protocol ID
- CR9106341
- Status last verified
- Apr 2016
- First submitted
- 28 Mar 2008
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400 mg Ronacaleret (a Calcium-sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females.
- ClinicalTrials.gov ID
- NCT00651534
- Acronym / sponsor ID
- CR9106341
- Conditions
- Osteoporosis
- Keywords
- Formulation Drug Study, healthy postmenopausal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- First posted
- 2 Apr 2008 (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 effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy postmenopausal women
- Non-smokers
- Body weight > or = 50 kg and BMI within the range 19-32 kg/m2
- Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
Key exclusion criteria (20 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
- Positive urine drug screen at screening
- Positive urine test for alcohol at pre-dose
- Positive for HIV or hepatitis B or C virus at screening
- Urinary cotinine levels indicative of smoking 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 |
|---|---|---|
| Ronacaleret | Drug | – |
Primary outcome
Not reported in the source record.
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 2 May 2016.
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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 Ronacaleret 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 6 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 2 May 2016. 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.
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 2 May 2016.