Pulmonary Disease, Chronic ObstructivePhase 1NCT00504439
A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects
A Phase 1 study testing SB-656933-AAA and Simvastatin in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
To assess safety of SB-656933 following repeat dosing for 14 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- SB-656933-AAA and Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2007to 6 Sep 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult female, aged 18-65 years.
- Female must not be able to have children.
- Non-smoking for the last 6 months.
Who cannot join
- Any serious medical condition.
- Hepatitis B or C and/or HIV positive.
- Currently on HRT, or other medication except paracetamol.
- Body Mass Index >30.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo Controlled, Dose Ascending, Parallel Group Study to Evaluate the Safety, Tolerability, Steady State Pharmacokinetics and Pharmacodynamics of SB-656933-AAA Following Repeated Doses in Healthy Adult Subjects. The Pharmacokinetic Interaction Between Repeated Doses of SB-656933-AAA and Single Dose of Simvastatin Will Also be Assessed
To assess safety of SB-656933 following repeat dosing for 14 days.
Read the detailed description
A randomised, double-blind, placebo controlled, dose ascending, parallel group study to evaluate the safety, tolerability, steady state pharmacokinetics and pharmacodynamics of SB-656933-AAA following repeated doses in healthy adult subjects. The pharmacokinetic interaction between repeated doses of SB-656933-AAA and single dose of simvastatin will also be assessed.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- SB-656933-AAA, Matching placebo, Simvastatin
- Keywords
- COPD,, CD11b,, CXCR2,, safety,, repeat dose,, tolerability., SB-656933,
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-656933-AAADrug
Also called SB-656933
The doses of SB-656933 (20 mg, 50 mg or 100 mg) will be provided as a combination of 10 mg and 50 mg tablets of SB-656933-AAA. The tablets will be administered orally.
Matching placeboDrug
SB-656933-AAA matching placebo tablets will be administered orally.
SimvastatinDrug
Simvastatin will be provided as a 40 mg tablet.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days. Receives: Drug: SB-656933-AAA; Drug: Matching placebo |
| Cohort 2 | Experimental | Subjects will be administered 40 mg simvastatin on day 1 followed by a washout period of two days. From day 3, the subjects will receive 50 mg of SB-656933-AAA once daily or matching placebo once daily for 14 days. On day 17, subjects will be administered 40 mg simvastatin along with SB-656933-AAA to assess statin interaction. Receives: Drug: SB-656933-AAA; Drug: Matching placebo; Drug: Simvastatin |
| Cohort 3 | Experimental | Subjects will be administered 100 mg SB-656933-AAA/ day or matching placebo for 14 days. Dosing will initiate after cohort I and II have completed dosing. Receives: Drug: SB-656933-AAA; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety of SB-656933 after repeat doses.
Measured: after repeat doses
Secondary outcomes (1)
Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing.
Measured: 14 days of repeat dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study start4 Jun 2007
- Primary completion6 Sep 2007
- Study completion6 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Parallel groups
- Enrolment
- 36 participants (actual)
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
- NCT00504439
- Sponsor's protocol ID
- CR2100609
- Status last verified
- Aug 2017
- First submitted
- 18 Jul 2007
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled, Dose Ascending, Parallel Group Study to Evaluate the Safety, Tolerability, Steady State Pharmacokinetics and Pharmacodynamics of SB-656933-AAA Following Repeated Doses in Healthy Adult Subjects. The Pharmacokinetic Interaction Between Repeated Doses of SB-656933-AAA and Single Dose of Simvastatin Will Also be Assessed
- ClinicalTrials.gov ID
- NCT00504439
- Acronym / sponsor ID
- CR2100609
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD,, CD11b,, CXCR2,, safety,, repeat dose,, tolerability., SB-656933,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2007 (actual)
- Primary completion
- 6 Sep 2007 (actual)
- Study completion
- 6 Sep 2007 (actual)
- First posted
- 20 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.
To assess safety of SB-656933 following repeat dosing for 14 days.
Detailed description
A randomised, double-blind, placebo controlled, dose ascending, parallel group study to evaluate the safety, tolerability, steady state pharmacokinetics and pharmacodynamics of SB-656933-AAA following repeated doses in healthy adult subjects. The pharmacokinetic interaction between repeated doses of SB-656933-AAA and single dose of simvastatin will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SB-656933-AAA, Drug: Matching placeboSubjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days. |
| Cohort 2 | Experimental | Drug: SB-656933-AAA, Drug: Matching placebo, Drug: SimvastatinSubjects will be administered 40 mg simvastatin on day 1 followed by a washout period of two days. From day 3, the subjects will receive 50 mg of SB-656933-AAA once daily or matching placebo once daily for 14 days. On day 17, subjects will be administered 40 mg simvastatin along with SB-656933-AAA to assess statin interaction. |
| Cohort 3 | Experimental | Drug: SB-656933-AAA, Drug: Matching placeboSubjects will be administered 100 mg SB-656933-AAA/ day or matching placebo for 14 days. Dosing will initiate after cohort I and II have completed dosing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult female, aged 18-65 years.
- Female must not be able to have children.
- Non-smoking for the last 6 months.
Key exclusion criteria (4 listed)
- Any serious medical condition.
- Hepatitis B or C and/or HIV positive.
- Currently on HRT, or other medication except paracetamol.
- Body Mass Index >30.
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-656933-AAAAlso: SB-656933The doses of SB-656933 (20 mg, 50 mg or 100 mg) will be provided as a combination of 10 mg and 50 mg tablets of SB-656933-AAA. The tablets will be administered orally. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Matching placeboSB-656933-AAA matching placebo tablets will be administered orally. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| SimvastatinSimvastatin will be provided as a 40 mg tablet. | Drug | Cohort 2 |
Primary outcome
Assess safety of SB-656933 after repeat doses.
Time frame: after repeat doses
1 secondary outcome
Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing.
Time frame: 14 days of repeat dosing.
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 3 Aug 2017.
- Results for study CR2100609 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 SB-656933-AAA and Simvastatin in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
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 4 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 3 Aug 2017. 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 Kingdom. 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?
Assess safety of SB-656933 after repeat doses. (time frame: after repeat doses). 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 3 Aug 2017.