OsteoporosisPhase 1NCT00508534
A Study To Evaluate The Effects Of Repeat Dosing Of Esomeprazole On The Pharmacokinetics Of SB-751689 In Healthy People
A Phase 1 study testing SB-751689 in people with Osteoporosis, run by GlaxoSmithKline at 1 site in Singapore.
Trial summary
This study will examine the effects of altering gastric pH in healthy volunteers on the pharmacokinetics of SB-751689 with or without food. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- SB-751689
- How many people
- 13 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males or females between the ages of 21 and 55, inclusive, will be eligible for the study. Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- The subject has a body mass index (BMI) of 19 to 31 kg/m2 where BMI= (weight in kg)/(height in meters)2
- Subjects must be genotyped as poor metabolizers or heterozygous extensive metabolizers for CYP2C19.
- The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Genotyped homozygous extensive metabolizers for CYP2C19 (Section 6.1.1 CYP2C19 Polymorphism Genotyping).
- Any clinically relevant abnormality identified on the screening history and physical or laboratory examination, 12-lead electrocardiogram (ECG) and/or 24 hour Holter, including QTc > or = 450 msec.
- 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 23Show 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 (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.
- The subject has participated in a clinical trial and has 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 nonprescription drugs including antacids, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days or (14 days if the drug is a potential enzyme inducer or 5 half-lives, whichever is longer) prior to the first dose of study medication, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise subject safety.
- 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.
- History of pernicious anemia, pancreatitis, osteosarcoma or kidney stones.
- Medical conditions which might alter bone metabolism.
- Liver function tests (ALT, AST, GGT, alkaline phosphatase, total bilirubin) and/or parathyroid hormone (PTH) test or 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: An Open-Label Study to Evaluate the Effects of Repeat Dosing of Esomeprazole on the Pharmacokinetics of SB-751689 in Healthy Adult Subjects
This study will examine the effects of altering gastric pH in healthy volunteers on the pharmacokinetics of SB-751689 with or without food.
- Conditions
- Osteoporosis
- Being tested
- SB-751689
- Keywords
- pharmacokinetic study,, gastric pH
- 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.
Cmax and AUC of SB-751689 alone or after treatment with esomeprazole, and under fasted or fed conditions
Measured: over 1 week
Secondary outcomes (1)
Adverse event report, ECGs, vital signs, laboratory test, and clinical monitoring
Measured: over a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startJul 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
- None (open label)
- Enrolment
- 13 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
- NCT00508534
- Sponsor's protocol ID
- CR9106339
- Status last verified
- May 2009
- First submitted
- 26 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 Evaluate the Effects of Repeat Dosing of Esomeprazole on the Pharmacokinetics of SB-751689 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00508534
- Acronym / sponsor ID
- CR9106339
- Conditions
- Osteoporosis
- Keywords
- pharmacokinetic study,, gastric pH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 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 effects of altering gastric pH in healthy volunteers on the pharmacokinetics of SB-751689 with or without food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult males or females between the ages of 21 and 55, inclusive, will be eligible for the study. Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- The subject has a body mass index (BMI) of 19 to 31 kg/m2 where BMI= (weight in kg)/(height in meters)2
- Subjects must be genotyped as poor metabolizers or heterozygous extensive metabolizers for CYP2C19.
- The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (23 listed)
- Genotyped homozygous extensive metabolizers for CYP2C19 (Section 6.1.1 CYP2C19 Polymorphism Genotyping).
- Any clinically relevant abnormality identified on the screening history and physical or laboratory examination, 12-lead electrocardiogram (ECG) and/or 24 hour Holter, including QTc > or = 450 msec.
- 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
Cmax and AUC of SB-751689 alone or after treatment with esomeprazole, and under fasted or fed conditions
Time frame: over 1 week
1 secondary outcome
Adverse event report, ECGs, vital signs, laboratory test, and clinical monitoring
Time frame: over a week
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.
Related trials for Osteoporosis
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
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 in people with Osteoporosis, run by GlaxoSmithKline at 1 site in Singapore.
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 4 inclusion and 23 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 Singapore. 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?
Cmax and AUC of SB-751689 alone or after treatment with esomeprazole, and under fasted or fed conditions (time frame: over 1 week). 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.