PK Study of IV Formulation of GW856553

NCT01039961 | Completed Phase 1

• 1 other identifier: 113022
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of an IV infusion of GW856553 in healthy volunteers.

Conditions

Cardiovascular Disease

Keywords

healthy volunteers; IV formulation study

Outcome Measures

Primary Outcomes (1)

• General safety and tolerability endpoints include changes in clinical laboratory assessments, spontaneous AE reporting, ECGs, vital signs and nursing/physician observations.

  Up to 15 days post IV infusion.

Secondary Outcomes (6)

• pHSP27 measurements

  Up to 24 hours post dose.

• hsCRP measurements

  Up to 24 hours post dose.

• Maximum Plasma Concentration [Cmax]

  Up to 24 hours post dose

• Area Under the Curve [AUC]

  Up to 24 hours post dose

• Time of maximum plasma concentation [Tmax]

  Up to 24 hours post dose

Study Arms (3)

1 mg IV

EXPERIMENTAL

Unit Dose Strength: 0.4 mg/mL

Drug: losmapimod 1 mg

?mg IV

EXPERIMENTAL

dose to be determined based on PK of first IV dose

Drug: losmapimod

15 mg (oral)

EXPERIMENTAL

two 7.5 mg tablets

Drug: losmapimod 15 mg

Interventions

losmapimod 1 mg DRUG

IV infusion

1 mg IV

losmapimod DRUG

IV infusion (dose to be determined based on PK from first dose)

?mg IV

losmapimod 15 mg DRUG

oral, two 7.5 mg tablets

15 mg (oral)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, CB2 2GG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23215699 BACKGROUND

Related Links

• Results for study 113022 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

6-(5-((cyclopropylamino)carbonyl)-3-fluoro-2-methylphenyl)-N-(2,2-dimethylprpyl)-3-pyridinecarboxamide

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: February 2, 2010
• Primary Completion: April 15, 2010
• Study Completion: April 15, 2010
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)