Pulmonary Disease, Chronic ObstructivePhase 1NCT00694902
Single Dose Escalation Study FTIM in Order to Assess Safety and Tolerability of GSK610677
A Phase 1 study testing GSK610677 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This study is the first administration of GSK610677 to man. The main aim of this clinical study is to investigate the safety and tolerability of different doses of the investigational medicinal product GSK610677. 2 cohorts of 8 subjects (Cohorts I and II) will be enrolled into this study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK610677
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 26 May 2008to 23 Sep 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range and determined by the investigator to be of clinical significance for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with liver function values outside the normal range should always be excluded from enrolment.
- Male between 18 and 50 years of age.
- Subjects must agree to use one of the contraception methods listed in Section 8. This criterion must be followed from the time of the first dose of study medication until 7 days after the last dose of study medication or 5 terminal half-live after the last dose of the study medication, whichever is longer.
- Body weight > 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- QTcB or QTcF < 450 msec.
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- Demonstrated ability to use the DISKUS inhaler device in a satisfactory and repeatable manner as judged by the investigator or designee.
- Current non-smoker, who has not used any inhaled tobacco product in the 12 month period preceding the screening visit and who have a total pack history of < 5 pack years (pack years = (number of cigarettes per day/20) x (no. of years smoked)).
- Screening pre-bronchodilator FEV1 > 80% predicted and FEV1/FVC ratio > 0.7.
Who cannot join
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Subject is known to be HIV seropositive.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
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- Use of prescription or non-prescription drugs, 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 GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- 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 investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subjects who have asthma or a history of asthma.
- The subject has respiratory symptoms, including "cold or flu" type symptoms or any respiratory infection/symptoms within 4 weeks of screening.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits or grapefruit hybrids from 7 days prior to the first dose of study medication.
- Chronic liver or biliary disease, history of Gilbert's syndrome.
- History in increased liver function tests above upper limit of normal in the past six months.
- Subjects who are kept due to regulatory or judicial order in an institution.
- Subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomized, Double-blind , Placebo Controlled, Dose Escalating Cross-over Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Inhaled Doses of GSK610677 and Placebo in Healthy Male Subjects
This study is the first administration of GSK610677 to man. The main aim of this clinical study is to investigate the safety and tolerability of different doses of the investigational medicinal product GSK610677. 2 cohorts of 8 subjects (Cohorts I and II) will be enrolled into this study. Individual subjects in each cohort will have up to 3 treatment periods. In each treatment period, subjects will receive a single inhaled dose of GSK610677 or placebo. Predicted doses are: 10, 30, 50 100 250 and 500ug.For individual subjects in each cohort, there will be a minimum wash out period of at least 10 days. In this period safety and tolerability data will be collected prior to dose to the next level.After safety review meetings between the site and the sponsor following the administration of the 500 ug dose, it was decided to add an extra cohort (Cohort III) of 8 subjects and administer 1000µg. Each subject in Cohort III will undergo a screening visit, one treatment period, and a follow up visit.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK610677, Placebo
- Keywords
- Healthy Volunteers
- 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.
GSK610677Drug
GSK610677 Multi-Dose Powder Inhaler will be available in the strength of 10, 50, 100 and 25 microgram with dose levels of 10, 30, 50, 100, 250, 500 and 1000 microgram. Subjects will receive GSK610677 as single inhale dose.
PlaceboDrug
Matching Placebo for GSK610677 will be available as Multi-Dose Powder Inhaler. Subjects will receive Placebo as single inhale dose.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 of Cohort-I | Experimental | Subjects in Sequence 1 will receive Placebo during treatment period 1, 50 microgram GSK610677 during treatment period 2 and 250 microgram GSK610677 during treatment period 3. Receives: Drug: GSK610677; Drug: Placebo |
| Sequence 2 of Cohort-I | Experimental | Subjects in Sequence 2 will receive 10 microgram GSK610677 during treatment period 1, Placebo during treatment period 2 and 250 microgram GSK610677 during treatment period 3. Receives: Drug: GSK610677; Drug: Placebo |
| Sequence 3 of Cohort-I | Experimental | Subjects in Sequence 3 will receive 10 microgram GSK610677 during treatment period 1, 50 microgram GSK610677 during treatment period 2 and Placebo during treatment period 3. Receives: Drug: GSK610677; Drug: Placebo |
| Sequence 4 of Cohort-I | Experimental | Subjects in Sequence 4 will receive 10 microgram GSK610677 during treatment period 1, 50 microgram GSK610677 during treatment period 2 and 250 microgram GSK610677 during treatment period 3. Receives: Drug: GSK610677 |
| Sequence 5 of Cohort-II | Experimental | Subjects in Sequence 5 will receive Placebo during treatment period 1, 100 microgram GSK610677 during treatment period 2 and 500 microgram GSK610677 during treatment period 3. Receives: Drug: GSK610677; Drug: Placebo |
| Sequence 6 of Cohort-II | Experimental | Subjects in Sequence 6 will receive 30 microgram GSK610677 during treatment period 1, Placebo during treatment period 2 and 500 microgram GSK610677 during treatment period 3. Receives: Drug: GSK610677; Drug: Placebo |
| Sequence 7 of Cohort-II | Experimental | Subjects in Sequence 7 will receive 30 microgram GSK610677 during treatment period 1, 100 microgram GSK610677 during treatment period 2 and Placebo during treatment period 3. Receives: Drug: GSK610677; Drug: Placebo |
| Sequence 8 of Cohort-II | Experimental | Subjects in Sequence 7 will receive 30 microgram GSK610677 during treatment period 1, 100 microgram GSK610677 during treatment period 2 and 500 microgram GSK610677 during treatment period 3. Receives: Drug: GSK610677 |
| Cohort III | Experimental | Subjects in Cohort III after randomization will either receive 1000 microgram GSK610677 or placebo. Receives: Drug: GSK610677; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples over a period of 48 hours.
Measured: Pre-dose, 5, 10, 15, 30 and 45 minutes, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post dose
Secondary outcomes (2)
Safety parameters over a period of the study, including ECG, Telemetry and vital sign. Continuous adverse event monitoring from dosing until study conclusion and follow up, 14-21 days after last dose.
Measured: Up to 21 days after last dose
Plasma GSK610677 and GSK1437357 concentrations
Measured: Up to 21 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study start26 May 2008
- Primary completion23 Sep 2008
- Study completion23 Sep 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
- Crossover
- Enrolment
- 24 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
- NCT00694902
- Sponsor's protocol ID
- IP2107882
- Status last verified
- Aug 2017
- First submitted
- 9 Jun 2008
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomized, Double-blind , Placebo Controlled, Dose Escalating Cross-over Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Inhaled Doses of GSK610677 and Placebo in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00694902
- Acronym / sponsor ID
- IP2107882
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 May 2008 (actual)
- Primary completion
- 23 Sep 2008 (actual)
- Study completion
- 23 Sep 2008 (actual)
- First posted
- 11 Jun 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 is the first administration of GSK610677 to man. The main aim of this clinical study is to investigate the safety and tolerability of different doses of the investigational medicinal product GSK610677. 2 cohorts of 8 subjects (Cohorts I and II) will be enrolled into this study. Individual subjects in each cohort will have up to 3 treatment periods. In each treatment period, subjects will receive a single inhaled dose of GSK610677 or placebo. Predicted doses are: 10, 30, 50 100 250 and 500ug.For individual subjects in each cohort, there will be a minimum wash out period of at least 10 days. In this period safety and tolerability data will be collected prior to dose to the next level.After safety review meetings between the site and the sponsor following the administration of the 500 ug dose, it was decided to add an extra cohort (Cohort III) of 8 subjects and administer 1000µg. Each subject in Cohort III will undergo a screening visit, one treatment period, and a follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 of Cohort-I | Experimental | Drug: GSK610677, Drug: PlaceboSubjects in Sequence 1 will receive Placebo during treatment period 1, 50 microgram GSK610677 during treatment period 2 and 250 microgram GSK610677 during treatment period 3. |
| Sequence 2 of Cohort-I | Experimental | Drug: GSK610677, Drug: PlaceboSubjects in Sequence 2 will receive 10 microgram GSK610677 during treatment period 1, Placebo during treatment period 2 and 250 microgram GSK610677 during treatment period 3. |
| Sequence 3 of Cohort-I | Experimental | Drug: GSK610677, Drug: PlaceboSubjects in Sequence 3 will receive 10 microgram GSK610677 during treatment period 1, 50 microgram GSK610677 during treatment period 2 and Placebo during treatment period 3. |
| Sequence 4 of Cohort-I | Experimental | Drug: GSK610677Subjects in Sequence 4 will receive 10 microgram GSK610677 during treatment period 1, 50 microgram GSK610677 during treatment period 2 and 250 microgram GSK610677 during treatment period 3. |
| Sequence 5 of Cohort-II | Experimental | Drug: GSK610677, Drug: PlaceboSubjects in Sequence 5 will receive Placebo during treatment period 1, 100 microgram GSK610677 during treatment period 2 and 500 microgram GSK610677 during treatment period 3. |
| Sequence 6 of Cohort-II | Experimental | Drug: GSK610677, Drug: PlaceboSubjects in Sequence 6 will receive 30 microgram GSK610677 during treatment period 1, Placebo during treatment period 2 and 500 microgram GSK610677 during treatment period 3. |
| Sequence 7 of Cohort-II | Experimental | Drug: GSK610677, Drug: PlaceboSubjects in Sequence 7 will receive 30 microgram GSK610677 during treatment period 1, 100 microgram GSK610677 during treatment period 2 and Placebo during treatment period 3. |
| Sequence 8 of Cohort-II | Experimental | Drug: GSK610677Subjects in Sequence 7 will receive 30 microgram GSK610677 during treatment period 1, 100 microgram GSK610677 during treatment period 2 and 500 microgram GSK610677 during treatment period 3. |
| Cohort III | Experimental | Drug: GSK610677, Drug: PlaceboSubjects in Cohort III after randomization will either receive 1000 microgram GSK610677 or placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range and determined by the investigator to be of clinical significance for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with liver function values outside the normal range should always be excluded from enrolment.
- Male between 18 and 50 years of age.
- Subjects must agree to use one of the contraception methods listed in Section 8. This criterion must be followed from the time of the first dose of study medication until 7 days after the last dose of study medication or 5 terminal half-live after the last dose of the study medication, whichever is longer.
- Body weight > 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (18 listed)
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Subject is known to be HIV seropositive.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer.
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 |
|---|---|---|
| GSK610677GSK610677 Multi-Dose Powder Inhaler will be available in the strength of 10, 50, 100 and 25 microgram with dose levels of 10, 30, 50, 100, 250, 500 and 1000 microgram. Subjects will receive GSK610677 as single inhale dose. | Drug | Cohort III, Sequence 1 of Cohort-I, Sequence 2 of Cohort-I, Sequence 3 of Cohort-I, Sequence 4 of Cohort-I, Sequence 5 of Cohort-II, Sequence 6 of Cohort-II, Sequence 7 of Cohort-II, Sequence 8 of Cohort-II |
| PlaceboMatching Placebo for GSK610677 will be available as Multi-Dose Powder Inhaler. Subjects will receive Placebo as single inhale dose. | Drug | Cohort III, Sequence 1 of Cohort-I, Sequence 2 of Cohort-I, Sequence 3 of Cohort-I, Sequence 5 of Cohort-II, Sequence 6 of Cohort-II, Sequence 7 of Cohort-II |
Primary outcome
Blood samples over a period of 48 hours.
Time frame: Pre-dose, 5, 10, 15, 30 and 45 minutes, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post dose
2 secondary outcomes
Safety parameters over a period of the study, including ECG, Telemetry and vital sign. Continuous adverse event monitoring from dosing until study conclusion and follow up, 14-21 days after last dose.
Time frame: Up to 21 days after last dose
Plasma GSK610677 and GSK1437357 concentrations
Time frame: Up to 21 days after last dose
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 10 Aug 2017.
- Results for study IP2107882 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 GSK610677 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in Germany.
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 9 inclusion and 18 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 10 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 Germany. 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?
Blood samples over a period of 48 hours. (time frame: Pre-dose, 5, 10, 15, 30 and 45 minutes, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours post dose). 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 10 Aug 2017.