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Trial details imported from ClinicalTrials.gov
Ethics application status
Single Dose Safety Study for Compound to Treat Post-Operative Nausea and Vomiting (PONV)
A Phase I, Randomized, Placebo-Controlled, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of the Captisol™ Formulation of Vestipitant (GW597599) in Healthy Adult Subjects
Universal Trial Number (UTN)
Post-Operative Nausea and Vomiting (PONV)
Oral and Gastrointestinal
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Description of intervention(s) / exposure
Treatment: Drugs - GW597599
Treatment: Drugs - Placebo
Experimental: Active Drug -
Placebo Comparator: Placebo -
Treatment: Drugs: GW597599
Single dose IV infusion
Treatment: Drugs: Placebo
Single dose IV infusion
Intervention code 
Comparator / control treatment
Primary outcome 
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Key inclusion criteria
1. Healthy as determined by a responsible and experienced 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 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.
2. Male or female between 18 and 65 years of age inclusive, at the time of signing the
3. 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 amenorrhea [in questionable cases a blood sample with simultaneous
follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147
pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose
menopausal status is in doubt will be required to use one of the contraception
methods in Section 8.1 if they wish to continue their HRT during the study.
Otherwise, they must discontinue HRT to allow confirmation of post-menopausal
status prior to study enrollment. For most forms of HRT, at least 2-4 week will
elapse between the cessation of HRT and the blood draw; this interval depends on
the type and dosage of HRT. Following confirmation of their post-menopausal
status, they can resume use of HRT during the study without use of a
- Child-bearing potential and agrees to use one of the contraception methods listed
in Section 8.1 for an appropriate period of time (as determined by the product
label or investigator) prior to the start of dosing to sufficiently minimize the
risk of pregnancy at that point. Female subjects must agree to use contraception
until after the follow-up visit and completion of all follow-up assessments or at
least 7 days after study drug administration, whichever is longer.
4. Body weight greater than or equal to 50 kg and BMI less than or equal to 31 kg/m2.
5. Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
6. QTcB or QTcF < 450 msec; or QTcB or QTcF < 480 msec in subjects with Bundle Branch
7. AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN
(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. The subject has a positive pre-study drug screen. A minimum list of drugs that will be
screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and
2. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening.
3. A positive test for HIV antibody.
4. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
5. 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: a half-pint (~240 ml) of beer, 1 glass (125
ml) of wine or 1 (25 ml) measure of spirits.
6. Smoking or regular use of tobacco- or nicotine-containing products within 2 weeks
prior to screening.
7. 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
8. 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.
9. History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinic
uses heparin to maintain intravenous cannula patency).
10. Pregnant females as determined by positive serum or urine hCG test at screening or
prior to dosing.
11. Lactating females.
12. Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
13. Unwillingness or inability to follow the procedures outlined in the protocol.
14. Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or
pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior
to the first dose of study medication.
15. 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).
16. Exposure to more than four new chemical entities within 12 months prior to the first
17. Subject is mentally or legally incapacitated.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Investigational Site - Melbourne
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
The purpose of this study is to describe the safety and tolerability and pharmacokinetics of
a single intravenous administration of the new, Sulfobutyl Ether-7-Beta-Cyclodextrin
(Captisol™) based, formulation in Healthy Adult Subjects.
Trial related presentations / publications