Pulmonary Disease, Chronic ObstructivePhase 1NCT00615576
Repeat Dose Study in Male Healthy Volunteer Smokers
A Phase 1 study testing SB-656933 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is a 4 to 6 week study to look at the safety and PK profile of SB656933 in healthy male smokers Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- SB-656933
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Mar 2008to 24 Jul 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male smokers who are between 18-65 years of age with normal genitourinary anatomy based on physical examination.
- The subjects should have a normal colour Doppler epididymal ultrasound (normal blood flow and epididymal morphology) at screening.
- The first 10 mL of urine voided (VB1) should be normal at screening and pre-dose.
- Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant females; or use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication.
- The subject has a QTc(B) <450msec at screening or prior to dosing
- Body weight = 50 kg (110 pounds) and body mass index (BMI) between 19 and 30 inclusive where: BMI =weight in kg/(height in meters)2
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- Healthy male smokers must smoke more than 10 cigarettes per day, for at least 2 months prior to screening and less than 30 cigarettes per day at the time of enrolment.
- Subjects with Forced Expiratory Volume (FEV1)=80% predicted and FEV1/Forced Vital Capacity (FVC) ratio=0.7.
- Signed and dated written informed consent prior to admission to the study
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or 12-lead ECG.
- The subject has liver function tests (LFT) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT (to be discussed with the sponsor, if necessary).
- Subjects with absolute neutrophil count (ANC) = 2.0x109/L.
- Subjects who have previously been exposed to testicular radiotherapy.
- Subjects who have had previous testicular or prostate surgery including vasectomy.
- History of prostatitis, epididymitis, epididymal cysts, structural abnormalities or testicular cancer.
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- Subjects with abnormalities of the renal tract, renal stones or history of Urinary Tract Infections (UTI's).
- Positive drug or alcohol test at screening or prior to dosing.
- Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody at screening
- Use of prescription or non-prescription medication in the last 7 days or 5 half-lives (whichever is longer) , particularly drugs that are P450 CYP3A4, CYP2B6, CYP2C8 or OATP1B1 substrates with a narrow therapeutic index , and including vitamins and herbal remedies such as St John's Wort prior to dose of study medication.
- Consumption of grapefruit or grapefruit juice within seven days prior to the first dose of study medication.
- Donation of blood in excess of 500 mL within a 56 day period prior to dosing.
- Exposure to more than 3 new chemical entities within 12 months prior to the first dosing day.
- Participation in a trial with any drug within 3 months before the start of the study or participation in a trial with a new chemical entity within 4 months before the start of the study.
- Are receiving treatment for smoking cessation.
- Are using tobacco products other than cigarettes (e.g. pipes, cigars, snuff, chewing tobacco).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SB-656933 Following 14 Days Repeat Dosing in Healthy Male Smokers
This is a 4 to 6 week study to look at the safety and PK profile of SB656933 in healthy male smokers
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- SB-656933, Placebo
- Keywords
- Smoker,, Male,, Chronic Obstructive Lung Disease, Cystic Fibrosis,, Healthy Volunteer,
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-656933Drug
SB-656933 will be available as white film coated, round tablet and will be available in strengths of 50 milligrams, administered orally once daily.
PlaceboDrug
A placebo tablet to visually match the SB-656933 tablet will also be supplied, administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving SB-656933 | Experimental | Eligible subjects will be randomized to receive once daily doses of 100 milligrams of SB- 656933 for 14 days. Receives: Drug: SB-656933 |
| Subjects receiving placebo | Placebo comparator | Eligible subjects will be randomized to receive placebo for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
-what the body does to the drug over a 17 day of dosing with 100mg of SB656933. -Safety of SB-656933: Adverse events, blood pressure, heart rate, electrocardiogram, epididymal ultrasound and lab tests
Measured: 17 days
-what the body does to the drug over a 17 day of dosing with 100mg of SB656933 by taking PK samples at:
Measured: pre-dose and at 0.5,1,2,3,4,6,8,12 and 24 hours post-dose on days 1 and 14; pre-dose on Day7. Additional samples at 32, 48 and 72 hours post-dose wil
-Safety of SB-656933: Adverse events every day for entire study period: blood pressure , heart rate and temperature
Measured: taken pre-dose, 30min, 1hr, and 2hr on Day1, Day2, Day7 and Day14 (supine only);
electrocardiogram
Measured: pre-dose, 2hr and 4 hr on Day1
Secondary outcomes (6)
- Looking at the actual sample size data to determine a larger theoretical population. -What the drug does to the body when present at its lowest level on day 14 as compared before drug given.
Measured: 17 days
Safety and tolerability of SB-656933 in subjects with cystic fibrosis, including adverse events, vital signs, clinical laboratory assessments, electrocardiographic (ECG) parameters, and lung function (FVC, FEV1)
Measured: Up to Day 28
Fluorocytometric quantitation of CXCL1-induced CD11b expression on peripheral blood neutrophils in ex-vivo assay.
Measured: Up to Day 14
Neutrophil shape change in response to stimulation with CXCL-1 in whole blood ex-vivo gated autofluorescence forward scatter (GAFS) assay.
Measured: Up to Day 14
Looking at the actual sample size data to determine a larger theoretical population.
Measured: Up to Day 14
What the drug does to the body when present at its lowest level on day 14 as compared before drug given.
Measured: on day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study start26 Mar 2008
- Primary completion24 Jul 2008
- Study completion24 Jul 2008
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
- Single group
- Enrolment
- 13 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
- NCT00615576
- Sponsor's protocol ID
- CR2111256
- Status last verified
- Aug 2017
- First submitted
- 1 Feb 2008
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SB-656933 Following 14 Days Repeat Dosing in Healthy Male Smokers
- ClinicalTrials.gov ID
- NCT00615576
- Acronym / sponsor ID
- CR2111256
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Smoker,, Male,, Chronic Obstructive Lung Disease, Cystic Fibrosis,, Healthy Volunteer,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2008 (actual)
- Primary completion
- 24 Jul 2008 (actual)
- Study completion
- 24 Jul 2008 (actual)
- First posted
- 14 Feb 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 is a 4 to 6 week study to look at the safety and PK profile of SB656933 in healthy male smokers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving SB-656933 | Experimental | Drug: SB-656933Eligible subjects will be randomized to receive once daily doses of 100 milligrams of SB- 656933 for 14 days. |
| Subjects receiving placebo | Placebo comparator | Drug: PlaceboEligible subjects will be randomized to receive placebo for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy adult male smokers who are between 18-65 years of age with normal genitourinary anatomy based on physical examination.
- The subjects should have a normal colour Doppler epididymal ultrasound (normal blood flow and epididymal morphology) at screening.
- The first 10 mL of urine voided (VB1) should be normal at screening and pre-dose.
- Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant females; or use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication.
- The subject has a QTc(B) <450msec at screening or prior to dosing
Key exclusion criteria (16 listed)
- Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or 12-lead ECG.
- The subject has liver function tests (LFT) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT (to be discussed with the sponsor, if necessary).
- Subjects with absolute neutrophil count (ANC) = 2.0x109/L.
- Subjects who have previously been exposed to testicular radiotherapy.
- Subjects who have had previous testicular or prostate surgery including vasectomy.
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-656933SB-656933 will be available as white film coated, round tablet and will be available in strengths of 50 milligrams, administered orally once daily. | Drug | Subjects receiving SB-656933 |
| PlaceboA placebo tablet to visually match the SB-656933 tablet will also be supplied, administered orally once daily. | Drug | Subjects receiving placebo |
Primary outcome
-what the body does to the drug over a 17 day of dosing with 100mg of SB656933. -Safety of SB-656933: Adverse events, blood pressure, heart rate, electrocardiogram, epididymal ultrasound and lab tests
Time frame: 17 days
-what the body does to the drug over a 17 day of dosing with 100mg of SB656933 by taking PK samples at:
Time frame: pre-dose and at 0.5,1,2,3,4,6,8,12 and 24 hours post-dose on days 1 and 14; pre-dose on Day7. Additional samples at 32, 48 and 72 hours post-dose wil
-Safety of SB-656933: Adverse events every day for entire study period: blood pressure , heart rate and temperature
Time frame: taken pre-dose, 30min, 1hr, and 2hr on Day1, Day2, Day7 and Day14 (supine only);
electrocardiogram
Time frame: pre-dose, 2hr and 4 hr on Day1
6 secondary outcomes
- Looking at the actual sample size data to determine a larger theoretical population. -What the drug does to the body when present at its lowest level on day 14 as compared before drug given.
Time frame: 17 days
Safety and tolerability of SB-656933 in subjects with cystic fibrosis, including adverse events, vital signs, clinical laboratory assessments, electrocardiographic (ECG) parameters, and lung function (FVC, FEV1)
Time frame: Up to Day 28
Fluorocytometric quantitation of CXCL1-induced CD11b expression on peripheral blood neutrophils in ex-vivo assay.
Time frame: Up to Day 14
Neutrophil shape change in response to stimulation with CXCL-1 in whole blood ex-vivo gated autofluorescence forward scatter (GAFS) assay.
Time frame: Up to Day 14
Looking at the actual sample size data to determine a larger theoretical population.
Time frame: Up to Day 14
What the drug does to the body when present at its lowest level on day 14 as compared before drug given.
Time frame: on day 14
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 8 Aug 2017.
- Results for study CR2111256 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 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 10 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 8 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. Some participants in this study may receive a placebo. 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?
-what the body does to the drug over a 17 day of dosing with 100mg of SB656933. -Safety of SB-656933: Adverse events, blood pressure, heart rate, electrocardiogram, epididymal ultrasound and lab tests (time frame: 17 days). The study lists 4 primary outcomes in all. 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 8 Aug 2017.