Single Dose Escalation First Time in Human PK Study - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00828867

Purpose

This is a first time in human (FTIH) study of single escalating doses of investigational study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects

Condition	Intervention	Phase
Healthy Subjects	Drug: 2000 mg GSK investigational drug Drug: selected dose fed GSK investigational drug Drug: 800 mg GSK investigational drug Drug: 200 mg GSK investigational drug Drug: 100 mg GSK investigational drug Drug: 1500 mg GSK investigational drug Drug: 400 mg GSK investigational drug	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Safety Study
Official Title:	A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single Dose Escalation First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Investigational Study Drug in Healthy Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram intervals, and ECG rhythm. [ Time Frame: Eighteen days ] [ Designated as safety issue: Yes ]
Pharmacokinetic parameters following single dose administration: area under the plasma concentration curve AUC 0 to inf, AUC 0 to t, AUC 0 to 24, maximum observed concentration , time to maximum observed concentration , terminal half life . [ Time Frame: Two days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

AUC 0 to inf and Cmax following single dose administration for the assessment of dose proportionality [ Time Frame: Two days ] [ Designated as safety issue: Yes ]
Amount excreted of unchanged study drug and renal clearance [ Time Frame: Two days ] [ Designated as safety issue: Yes ]
AUC 0 to inf, AUC 0 to t, AUC 0 to 24, Cmax, tmax and tlag if deemed appropriate with and without high fat calorie meal [ Time Frame: Two days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	41
Study Start Date:	November 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 4: Experimental	Drug: 800 mg GSK investigational drug NA
Cohort 1: Experimental	Drug: 100 mg GSK investigational drug NA
Cohort 6: Experimental	Drug: 2000 mg GSK investigational drug NA
Cohort 2: Experimental	Drug: 200 mg GSK investigational drug NA
Cohort 3: Experimental	Drug: 400 mg GSK investigational drug NA
Cohort 5: Experimental	Drug: 1500 mg GSK investigational drug NA
Cohort 7: Experimental	Drug: selected dose fed GSK investigational drug NA

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy
male
non-childbearling potential females
Body weight greater than or equal to 50 kg (110 lbs) for men and greater than or equal to 45 kg (99 lbs) for women. Body mass index (BMI) between 18.5-29.9 kg/m2 inclusive.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block on Screening ECG

Exclusion Criteria:

The subject has a 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.
A positive test for HIV antibody.
History of regular alcohol consumption within 6 months of the study defined as:

an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). A standard unit is defined as 10g ethanol which is equivalent to 100mL wine, 250mL full strength beer, 470mL light beer, 30mL spirits

The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the 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 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] human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Lactating females.
Subjects who have asthma or a history of asthma within the past 6 months.
History of smoking or history of regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pummelos, satsuma, ugli, tangerine, and tangelo, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828867

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Australia, New South Wales
GSK Investigational Site	Recruiting
Randwick, New South Wales, Australia, 2031

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111341
Study First Received:	December 8, 2008
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00828867 History of Changes
Health Authority:	Australia: Medicines Australia

Keywords provided by GlaxoSmithKline:

FTIH, single dose, food effect, healthy subjects, double-blind

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 10, 2009