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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01290133




Registration number
NCT01290133
Ethics application status
Date submitted
1/02/2011
Date registered
4/02/2011
Date last updated
13/10/2011

Titles & IDs
Public title
Single Dose Safety Study for Compound to Treat Post-Operative Nausea and Vomiting (PONV)
Scientific title
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
Secondary ID [1] 0 0
VNK114995
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Operative Nausea and Vomiting (PONV) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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 [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timepoint [1] 0 0
up to 5 weeks

Eligibility
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
informed consent.

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
contraceptive method.

- 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
Block.

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
bilirubin <35%).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
benzodiazepines.

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
subject safety.

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
dosing day.

17. Subject is mentally or legally incapacitated.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Accenture
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01290133
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01290133