A Study to Examine the Absorption of GSK561679 in Healthy Male Volunteers

NCT00539136 | Completed Phase 1

• 1 other identifier: CRS-110300
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted in healthy volunteers to investigate the absorption of GSK561679 using Gamma Scintigraphy, PillCam™ SB capsule and the acoustic vest.

Conditions

Healthy Subjects

Keywords

GSK561679,; Pharmacokinetic,; healthy volunteers,; Gamma Scintigraphy,; PillCam™,; acoustic vest

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic scope of GSK561679 after application in a solution and in a new tablet formula per treatment phase Complete gastric emptying of radioactive marker after application of GSK561679 Complete tablet breakdown per treatment phase

Secondary Outcomes (3)

• AUC(0-24h), AUC(0-t), AUC(0-∞) of GSK561679 after administration of GSK561679 in a solution (fasted) and in a new "optimized" tablet formulation (fasted and fed).

• lambda_Z (and t1/2), tlag, Ka, the time to absorb the 25, 50 and 90% of the total absorbed dose

• •Other pharmacokinetic parameters of GSK561679 per treatment phase •Safety and tolerability parameters, including adverse events, clinical laboratory,vital signs and 12-lead ECGs measured at each dosing period and throughout the study

Interventions

GSK561679 tablet or solution DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males aged 18-55 years, inclusive.
• Healthy subjects, defined as individuals who are free from clinically significant illness or disease (including peptic ulcer disease and psychiatric illness) as determined by their medical and psychiatric history (including family), physical examination, laboratory studies, and other tests.
• Body weight \>/= 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 inclusive
• Demonstrates no evidence of active disease, physical or mental impairment.
• Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.
• Non-smoker (abstinence from smoking for at least 6 months before the start of the study).
• Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG).
• Agree to remain in the clinic for the time defined in the protocol.
• Signed and dated written informed consent prior to admission to the study.
• The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

You may not qualify if:

• As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations, the physician responsible considers the subject unfit for the study.
• History of clinically significant psychiatric illness.
• Any history of suicidal attempts or behavior.
• Any history of an endocrine disorder including, but not limited to, diabetes or disorders of the hypothalamus, pituitary, adrenal, or thyroid glands, or gonadal disorder or dysfunction of the reproductive organs.
• History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
• Current or recent (within one year) gastrointestinal disease; a history of malabsorption, oesophageal reflux, irritable bowel syndrome or intestinal obstruction; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
• History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
• LFTs elevated \>1.5 times above the reference range at pre-study screening that remain elevated with a repeat LFT (to be discussed with the sponsor, if necessary).
• Any other clinically significant laboratory abnormality.
• The subject has a screening ECG with values outside ranges specified in protocol.
• A semi-supine systolic blood pressure less than 90 mmHg or greater than 140 mmHg or a semi-supine diastolic blood pressure of less than 60 mmHg or greater than 90mmHg; or a radial pulse rate less than 40 bpm or more than 90 bpm.
• A positive pre-study HIV 1, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of the start of the study. Subjects with a negative Hepatitis B, C and HIV test in last 3 months will not be required to repeat the tests.
• The subject has a positive pre-study urine drug/alcohol screen. .
• History of regular alcohol consumption averaging 21 drinks/week within 6 months of screening.
• Average daily caffeine intake equivalent to \> 4 cups of coffee or \> 6 cups of tea.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Lexington, Kentucky, 40503, United States

Location

MeSH Terms

Interventions

NBI 77860; Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 4, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 19, 2010

Record last verified: 2010-10

Locations

US (1)