Respiratory DisordersPhase 1NCT01476046
Safety Study of GSK1995057 Given as Single and Repeat Intravenous Doses in Healthy Subjects.
A Phase 1 study testing GSK1995057 single dose in people with Respiratory Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated after dosing. The study will also investigate how GSK1995057 is taken up, metabolised (chemically broken down), distributed through the body and excreted, and what some of the effects of the study drug are. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disorders
- What is being tested?
- GSK1995057 single dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Mar 2011to 17 Jun 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician.
- Male or female between 18 and 55 years of age inclusive
- A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and elevated FSH as per the local laboratory guidelines.
- Normal creatinine clearance values at screening
- Male subjects must agree to use one of the study specific contraception methods
- Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
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- Normal lung function at screening.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Available to complete all study assessments.
- Able to read, comprehend and write English at a sufficient level to complete study elated materials.
Who cannot join
- A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- Evidence of previous or active mycobacterium tuberculosis complex infection
- Recent history of and/or a positive test for Toxoplasma consistent with active oxoplasmosis infection.
- A positive test for influenza A/B taken within 7 days before dosing.
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- Current evidence or history of an influenza-like illness.
- Corrected QT interval (QTcF) >450msec from ECG readings.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol and the following can be used as a guide: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- The subject is unwilling to abstain from alcohol consumption from 24 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits.
- Subjects with a smoking history of >10 cigarettes per day in the last 3 months.
- 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: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) or exposure to more than four new chemical or biological entities within 12 months prior to the first dosing day.
- Subjects having received any type of vaccination within 3 weeks of the anticipated dosing start or are expected to be vaccinated within 3 weeks after the last dose.
- Current evidence of ongoing or acute infection, history of repeated or chronic significant infections or history of serious infection within three months of dosing.
- Subjects who have asthma or a history of asthma, COPD, other respiratory conditions or recurrent infections (a subject who suffered from childhood asthma but not as an adult may be included provided they fulfil other entry criteria).
- Subjects who have a known history of migraine headaches or are frequently suffering from other types of headaches which require medication (frequent defined as more than one headache in a fortnight).
- Use of prescription or non-prescription drugs (except simple analgesics), including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsors 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 including severe allergic reaction, angio-edema or anaphylaxis that, in the opinion of the investigator or sponsors Medical Monitor, contraindicates their participation.
- History of malignancy, except for adequately treated non-invasive cancer of the skin (basal or squamous cell) or cervical carcinoma in situ (>2 yrs prior to dosing).
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 3 month or 90 day period.
- Subject is unable to refrain from travelling to countries with a high prevalence of TB or other areas of prevalent infectious disease as judged by the investigator or the sponsors medical monitor from the start of screening until the final follow-up visit.
- Subject is mentally or legally incapacitated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamicsof Single and Repeat Doses of Intravenously Infused GSK1995057 in Healthy Subjects.
The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated after dosing. The study will also investigate how GSK1995057 is taken up, metabolised (chemically broken down), distributed through the body and excreted, and what some of the effects of the study drug are.
Read the detailed description
This study will be the first investigation of GSK1995057 in humans and is primarily designed to investigate safety and tolerability of single and repeat intravenously infused doses. The study will enrol healthy male subjects and healthy female subjects of non-child bearing potential and will also investigate immunogenicity, GSK1995057 distribution (pharmacokinetics), and potential impact on indicators of host immunity and normal immunological function. Safety, tolerability, immunogenicity, pharmacokinetic and pharmacodynamic data from this trial may facilitate further clinical investigations in healthy subjects dosed with GSK1995057 via the inhaled route, and ultimately clinical trials in patients with acute lung injury.
- Conditions
- Respiratory Disorders
- Being tested
- GSK1995057 single dose, Placebo
- Keywords
- Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS)
- Medical subject headings
- Respiration Disorders, Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1995057 single doseDrug
Single intravenous dose
PlaceboDrug
Single intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| GSK1995057 | Experimental | Single intravenous dose Receives: Drug: GSK1995057 single dose |
| Placebo | Placebo comparator | Single intravenous dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurance of adverse events.
Number and type of adverse events recorded during study.
Measured: From start of screening until 84 days after completion of single dose (Part A subjects) or first dose (Part B subjects).
Change from baseline in blood pressure.
Systolic and diastolic blood pressure values before and after dosing completion.
Measured: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in heart rate.
Heart rate before and after dosing completion.
Measured: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in respiration rate.
Respiration rate before and after dosing completion.
Measured: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in body temperature.
Body temperature before and after dosing completion.
Measured: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in heart function.
Holter recording.
Measured: For 24hrs during screening, then for 1 hour before dosing to 24 hours after dosing starts (in Part A subjects only, except for cohort 7).
Change from baseline in heart function
Lead II cardiac telemetry.
Measured: From 1 hour before dosing to 12 hours after dosing starts for each dose.
Change from baseline in heart function.
12-lead ECG recording.
Measured: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in lung function.
FEV1 and FVC measurements.
Measured: From start of screening until 28 days after completion of single or repeat dosing.
Change from baseline in laboratory safety data.
Clinical chemistry, haematology and routine urinalysis.
Measured: From start of screening until 28 days after completion of single or repeat dosing.
Secondary outcomes (6)
Plasma pharmacokinetics of GSK1995057
Levels of GSK1995057 in blood samples.
Measured: From the first day of dosing until 48 hours after the completion of dosing.
Urine pharmacokinetics of GSK1995057
Levels of GSK1995057 in urine samples from cohort 6 subjects only.
Measured: From 1 hour before the only dose until 48 hours after the dose.
Bronchoalveolar lavage fluid (BALF) (saline flushed into and then collected from a lung) pharmacokinetics.
Levels of GSK1995057 in BALF from cohort 7 subjects only.
Measured: At 2 hrs after the completion of the only dose.
Effect of GSK1995057 on host immunity and immunological function
Levels of pharmacodynamic and immune function biomarkers in blood samples.
Measured: From the day before dosing starts to 28 days after dosing completion.
Effects of GSK1995057 on host immunity and immunological function
Levels of pharmacodynamic and immune function biomarkers in BALF from cohort 7 subjects only.
Measured: At 2 hrs after the completion of the only dose.
Immunogenic effect of GSK1995057
Levels of anti-GSK1995057 antibodies in blood samples
Measured: From the start of screening (cohorts 1-4 only) or from the day before the start of dosing until 84 days after the completion of single or repeat dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study start8 Mar 2011
- Primary completion17 Jun 2012
- Study completion17 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DisordersStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 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
- NCT01476046
- Sponsor's protocol ID
- 110951
- Status last verified
- Jun 2017
- First submitted
- 15 Mar 2011
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamicsof Single and Repeat Doses of Intravenously Infused GSK1995057 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01476046
- Acronym / sponsor ID
- 110951
- Conditions
- Respiratory Disorders
- Keywords
- Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2011 (actual)
- Primary completion
- 17 Jun 2012 (actual)
- Study completion
- 17 Jun 2012 (actual)
- First posted
- 22 Nov 2011 (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.
The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated after dosing. The study will also investigate how GSK1995057 is taken up, metabolised (chemically broken down), distributed through the body and excreted, and what some of the effects of the study drug are.
Detailed description
This study will be the first investigation of GSK1995057 in humans and is primarily designed to investigate safety and tolerability of single and repeat intravenously infused doses. The study will enrol healthy male subjects and healthy female subjects of non-child bearing potential and will also investigate immunogenicity, GSK1995057 distribution (pharmacokinetics), and potential impact on indicators of host immunity and normal immunological function. Safety, tolerability, immunogenicity, pharmacokinetic and pharmacodynamic data from this trial may facilitate further clinical investigations in healthy subjects dosed with GSK1995057 via the inhaled route, and ultimately clinical trials in patients with acute lung injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK1995057 | Experimental | Drug: GSK1995057 single doseSingle intravenous dose |
| Placebo | Placebo comparator | Drug: PlaceboSingle intravenous dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy as determined by a responsible and experienced physician.
- Male or female between 18 and 55 years of age inclusive
- A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and elevated FSH as per the local laboratory guidelines.
- Normal creatinine clearance values at screening
- Male subjects must agree to use one of the study specific contraception methods
Key exclusion criteria (22 listed)
- A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- Evidence of previous or active mycobacterium tuberculosis complex infection
- Recent history of and/or a positive test for Toxoplasma consistent with active oxoplasmosis infection.
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 |
|---|---|---|
| GSK1995057 single doseSingle intravenous dose | Drug | GSK1995057 |
| PlaceboSingle intravenous dose | Drug | Placebo |
Primary outcome
Occurance of adverse events.
Time frame: From start of screening until 84 days after completion of single dose (Part A subjects) or first dose (Part B subjects).
Number and type of adverse events recorded during study.
Change from baseline in blood pressure.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Systolic and diastolic blood pressure values before and after dosing completion.
Change from baseline in heart rate.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Heart rate before and after dosing completion.
Change from baseline in respiration rate.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Respiration rate before and after dosing completion.
Change from baseline in body temperature.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Body temperature before and after dosing completion.
Change from baseline in heart function.
Time frame: For 24hrs during screening, then for 1 hour before dosing to 24 hours after dosing starts (in Part A subjects only, except for cohort 7).
Holter recording.
Change from baseline in heart function
Time frame: From 1 hour before dosing to 12 hours after dosing starts for each dose.
Lead II cardiac telemetry.
Change from baseline in heart function.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
12-lead ECG recording.
Change from baseline in lung function.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
FEV1 and FVC measurements.
Change from baseline in laboratory safety data.
Time frame: From start of screening until 28 days after completion of single or repeat dosing.
Clinical chemistry, haematology and routine urinalysis.
6 secondary outcomes
Plasma pharmacokinetics of GSK1995057
Time frame: From the first day of dosing until 48 hours after the completion of dosing.
Urine pharmacokinetics of GSK1995057
Time frame: From 1 hour before the only dose until 48 hours after the dose.
Bronchoalveolar lavage fluid (BALF) (saline flushed into and then collected from a lung) pharmacokinetics.
Time frame: At 2 hrs after the completion of the only dose.
Effect of GSK1995057 on host immunity and immunological function
Time frame: From the day before dosing starts to 28 days after dosing completion.
Effects of GSK1995057 on host immunity and immunological function
Time frame: At 2 hrs after the completion of the only dose.
Immunogenic effect of GSK1995057
Time frame: From the start of screening (cohorts 1-4 only) or from the day before the start of dosing until 84 days after the completion of single or 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 12 Jun 2017.
- Results for study 110951 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 GSK1995057 single dose in people with Respiratory Disorders, 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 22 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 12 Jun 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?
Occurance of adverse events. (time frame: From start of screening until 84 days after completion of single dose (Part A subjects) or first dose (Part B subjects).). The study lists 10 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 12 Jun 2017.