GSK962040 Drug-drug Interaction Study With Ketoconazole

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01039974
• Date of registration: 23/12/2009
• Primary sponsor: GlaxoSmithKline
• Public title: GSK962040 Drug-drug Interaction Study With Ketoconazole
• Scientific title: An Open-label, Randomized, Single Sequence, Two Period Study to Assess the Effect of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of GSK962040 in Healthy Volunteers
• Date of first enrolment: September 2009
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01039974
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.
In any case, liver function tests must be strictly within the normal range at
screening.

- Male or female between 18 and 65 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
amenorrhea [in questionable cases a blood sample with simultaneous follicle
stimulating hormone (FSH) > 40 MlU/mL and estradiol < 40 pg/mL (<140 pmol/L) is
confirmatory].

- 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 for at
least 5 days following the last dose of study medication. GSK962040 and
ketoconazole are defined as study medications.

- Male subjects must agree to use one of the contraception methods listed in Section
8.1. This criterion must be followed from the time of the first dose of study
medication through at least 5 days following the last dose of study medication.
GSK962040 and ketoconazole are defined as study medications.

- Body weight > or = 50 kg and BMI within the range 18.5-29.9 kg/m2 (inclusive).

- Capable of giving written informed consent

- QTcB or QTcF < 450 msec or QTc<480msec in subjects with Bundle Branch Block based on
single or average QTc value of triplicate values obtained over a brief recording
period.

- Normal physical examination (physical exam demonstrates no evidence of clinically
active disease or physical or mental impairment). A subject with a clinical
abnormality may be included only if the Principal Investigator or physician designee
considers that the abnormality will not introduce additional risk factors and will
not interfere with the study procedures. Consultation with the GSK medical monitor is
required before such subjects may be included.

Exclusion Criteria:

- History of major gastrointestinal surgical procedure.

- History of cholecystectomy or biliary tract disease.

- A history or presence of recreational drug abuse or dependence or current abuse as
evidenced by positive pre-study drug/alcohol screen. A minimum list of drugs that
will be screened for include amphetamines, barbiturates, cocaine, opiates,
cannabinoids and benzodiazepines.

- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening.

- History of regular alcohol consumption within 6 months of the study defined as:

- An average weekly intake of >14 drinks for males or >7 drinks for females. One drink
is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of
wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.

- 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).

- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.

- 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.

- 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.

- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.

- Pregnant females as determined by positive serum or urine hCG test (from the first
urine of the day) at screening or prior to dosing.

- Lactating or pregnant females.

- Unwillingness or inability to follow the procedures outlined in the protocol.

- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and
pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior
to the first dose of study medication.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Gastroparesis

Healthy Volunteer

Intervention(s)

Drug: GSK962040

Drug: Ketoconazole

Primary Outcome(s)

Pharmacokinetic parameters (AUC(0-inf), and Cmax) of GSK962040 [Time Frame: Duration of dosing]

Secondary Outcome(s)

Additional pharmacokinetic parameters of GSK962040, i.e., tmax, t1/2, AUC(0-t) [Time Frame: Duration of dosing]

Safety and tolerability assessments, consisting of AEs, ECGs, vital signs, clinical laboratory tests. [Time Frame: Duration of dosing]

To characterize the nature of the GSK962040-related material in plasma, 24-hour urine, and bile. [Time Frame: 24 h]

Secondary ID(s)

112648

Source(s) of Monetary Support

Please refer to primary and secondary sponsors