Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: The purpose of this study is to evaluate the safety of an IV infusion of GW856553 in healthy volunteers.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
General safety and tolerability endpoints include changes in clinical laboratory assessments, spontaneous AE reporting, ECGs, vital signs and nursing/physician observations.
Timeframe: Up to 15 days post IV infusion.
Secondary outcomes:
pHSP27 measurements
Timeframe: Up to 24 hours post dose.
hsCRP measurements
Timeframe: Up to 24 hours post dose.
Maximum Plasma Concentration [Cmax]
Timeframe: Up to 24 hours post dose
Area Under the Curve [AUC]
Timeframe: Up to 24 hours post dose
Time of maximum plasma concentation [Tmax]
Timeframe: Up to 24 hours post dose
Half life [T1/2]
Timeframe: Up to 24 hours post dose
Interventions:
Drug: losmapimod 1 mg
Drug: losmapimod
Drug: losmapimod 15 mg
Enrollment:
16
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
April Barbour, Lea Sarov-Blat, Gengqian Cai, Michael Fossler, Dennis Sprecher, Joann Graggaber, Adam McGeoch, Jo Maison, Joseph Cheriyan. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Losmapimod following a Single Intravenous or Oral Dose in Healthy Volunteers. Br J Clin Pharmacol. 2012;ePub ahead of print ahead of print:
Barbour A, Sarov-Blat L, Cai G, Fossler M, Sprecher D, Graggaber J, McGeoch A, 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;76(1):99-106
Medical condition
Cardiovascular Disease
Product
losmapimod
Collaborators
Not applicable
Study date(s)
February 2010 to April 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
Yes
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin
- >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
- result within 3 months of screening
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- 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 location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-15-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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