Cardiovascular DiseasePhase 1NCT01039961
PK Study of IV Formulation of GW856553
A Phase 1 study testing losmapimod 1 mg, losmapimod and losmapimod 15 mg in people with Cardiovascular Disease, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety of an IV infusion of GW856553 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- losmapimod 1 mg, losmapimod and losmapimod 15 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2010to 15 Apr 2010
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea
- Male subjects must agree to use contraception from the time of the first dose of study medication until seven days following the last dose.
- Body weight >50kg (110 pounds) and body mass index (BMI) within the range >19 and <30kg/m2.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- QTcB or QTcF < 450 msec.
Who cannot join
- A positive pre-study 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 Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- 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 8g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125ml) of wine or 1 (25ml) measure of spirits.
- Treatment with an investigational product within 90 days or 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to dosing in this study.
Show all 13Show fewer
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements), 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 until completion of the follow-up visit, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Dose(s) and a Single Oral Dose of GW856553 in Healthy Volunteers
The purpose of this study is to evaluate the safety of an IV infusion of GW856553 in healthy volunteers.
Read the detailed description
The aims of this study are to evaluate the safety and tolerability of single intravenous (IV) doses of GW856553 in healthy adult subjects and to investigate the relationship between PK and PD markers within the first few hours following administration of study drug to support progression of this formulation into a patient population.
Subjects in Cohort 1 (n=4) will receive a single 1mg IV dose (given as a 15 minute infusion) of GW856553. Safety, tolerability and PK exposures will be reviewed, and in an optional cohort (Cohort 2) (n=4), the dose may be adjusted upward or downward based on data from Cohort 1. Based on the results from Cohort 1 (and Cohort 2 if required), Cohort 3 (n=12) will be dosed appropriately to receive a single IV 15 minute infusion of GW856553.
After a one week washout, Cohort 3 subjects will receive a single oral dose of 15mg GW856553. Access to both IV and oral PK in the same individuals will permit calculation of absolute bioavailability for the oral dose. Subjects will be resident in the research unit from the morning prior to dosing until after the last PK blood sample is collected at 24 hours after the dose of study drug (excluding any washout period).
- Conditions
- Cardiovascular Disease
- Being tested
- losmapimod 1 mg, losmapimod, losmapimod 15 mg
- Keywords
- healthy volunteers, IV formulation study
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
losmapimod 1 mgDrug
IV infusion
losmapimodDrug
IV infusion (dose to be determined based on PK from first dose)
losmapimod 15 mgDrug
oral, two 7.5 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 mg IV | Experimental | Unit Dose Strength: 0.4 mg/mL Receives: Drug: losmapimod 1 mg |
| ?mg IV | Experimental | dose to be determined based on PK of first IV dose Receives: Drug: losmapimod |
| 15 mg (oral) | Experimental | two 7.5 mg tablets Receives: Drug: losmapimod 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
General safety and tolerability endpoints include changes in clinical laboratory assessments, spontaneous AE reporting, ECGs, vital signs and nursing/physician observations.
Measured: Up to 15 days post IV infusion.
Secondary outcomes (6)
pHSP27 measurements
Measured: Up to 24 hours post dose.
hsCRP measurements
Measured: Up to 24 hours post dose.
Maximum Plasma Concentration [Cmax]
Measured: Up to 24 hours post dose
Area Under the Curve [AUC]
Measured: Up to 24 hours post dose
Time of maximum plasma concentation [Tmax]
Measured: Up to 24 hours post dose
Half life [T1/2]
Measured: Up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study start2 Feb 2010
- Primary completion15 Apr 2010
- Study completion15 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT01039961
- Sponsor's protocol ID
- 113022
- Status last verified
- Jun 2017
- First submitted
- 23 Dec 2009
- Last updated
- 14 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.
Publications
Barbour AM, Sarov-Blat L, Cai G, Fossler MJ, Sprecher DL, Graggaber J, McGeoch AT, Maison J, Cheriyan J. Safety, tolerability, pharmacokinetics and pharmacodynamics of losmapimod following a single intravenous or oral dose in healthy volunteers. Br J Clin Pharmacol. 2013 Jul;76(1):99-106. doi: 10.1111/bcp.12063.
PubMed 23215699
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Dose(s) and a Single Oral Dose of GW856553 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01039961
- Acronym / sponsor ID
- 113022
- Conditions
- Cardiovascular Disease
- Keywords
- healthy volunteers, IV formulation study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2010 (actual)
- Primary completion
- 15 Apr 2010 (actual)
- Study completion
- 15 Apr 2010 (actual)
- First posted
- 25 Dec 2009 (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 purpose of this study is to evaluate the safety of an IV infusion of GW856553 in healthy volunteers.
Detailed description
The aims of this study are to evaluate the safety and tolerability of single intravenous (IV) doses of GW856553 in healthy adult subjects and to investigate the relationship between PK and PD markers within the first few hours following administration of study drug to support progression of this formulation into a patient population.
Subjects in Cohort 1 (n=4) will receive a single 1mg IV dose (given as a 15 minute infusion) of GW856553. Safety, tolerability and PK exposures will be reviewed, and in an optional cohort (Cohort 2) (n=4), the dose may be adjusted upward or downward based on data from Cohort 1. Based on the results from Cohort 1 (and Cohort 2 if required), Cohort 3 (n=12) will be dosed appropriately to receive a single IV 15 minute infusion of GW856553.
After a one week washout, Cohort 3 subjects will receive a single oral dose of 15mg GW856553. Access to both IV and oral PK in the same individuals will permit calculation of absolute bioavailability for the oral dose. Subjects will be resident in the research unit from the morning prior to dosing until after the last PK blood sample is collected at 24 hours after the dose of study drug (excluding any washout period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 mg IV | Experimental | Drug: losmapimod 1 mgUnit Dose Strength: 0.4 mg/mL |
| ?mg IV | Experimental | Drug: losmapimoddose to be determined based on PK of first IV dose |
| 15 mg (oral) | Experimental | Drug: losmapimod 15 mgtwo 7.5 mg tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea
- Male subjects must agree to use contraception from the time of the first dose of study medication until seven days following the last dose.
Key exclusion criteria (13 listed)
- A positive pre-study 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 Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- 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 8g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125ml) of wine or 1 (25ml) measure of spirits.
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 |
|---|---|---|
| losmapimod 1 mgIV infusion | Drug | 1 mg IV |
| losmapimodIV infusion (dose to be determined based on PK from first dose) | Drug | ?mg IV |
| losmapimod 15 mgoral, two 7.5 mg tablets | Drug | 15 mg (oral) |
Primary outcome
General safety and tolerability endpoints include changes in clinical laboratory assessments, spontaneous AE reporting, ECGs, vital signs and nursing/physician observations.
Time frame: Up to 15 days post IV infusion.
6 secondary outcomes
pHSP27 measurements
Time frame: Up to 24 hours post dose.
hsCRP measurements
Time frame: Up to 24 hours post dose.
Maximum Plasma Concentration [Cmax]
Time frame: Up to 24 hours post dose
Area Under the Curve [AUC]
Time frame: Up to 24 hours post dose
Time of maximum plasma concentation [Tmax]
Time frame: Up to 24 hours post dose
Half life [T1/2]
Time frame: Up to 24 hours post 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 14 Jun 2017.
- Background: PubMed 23215699Barbour AM, Sarov-Blat L, Cai G, Fossler MJ, Sprecher DL, Graggaber J, McGeoch AT, Maison J, Cheriyan J. Safety, tolerability, pharmacokinetics and pharmacodynamics of losmapimod following a single intravenous or oral dose in healthy volunteers. Br J Clin Pharmacol. 2013 Jul;76(1):99-106. doi: 10.1111/bcp.12063.
- Results for study 113022 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 losmapimod 1 mg, losmapimod and losmapimod 15 mg in people with Cardiovascular Disease, 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 8 inclusion and 13 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 14 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. 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?
General safety and tolerability endpoints include changes in clinical laboratory assessments, spontaneous AE reporting, ECGs, vital signs and nursing/physician observations. (time frame: Up to 15 days post IV infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039961, which also lists 1 linked publication.
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 14 Jun 2017.