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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00427141
Other study ID # OPS106400
Secondary ID
Status Completed
Phase Phase 1
First received January 24, 2007
Last updated May 31, 2012
Start date October 2006

Study information

Verified date February 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion criteria:

- Healthy as determined by a physician

- Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)

- Body weight > = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)

Exclusion criteria:

- Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening

- Male and female subjects not willing to follow study specified contraceptive methods

- Subjects taking any recreational drugs

- Regular use of tobacco- or nicotine-containing products within 6 months prior to screening

- Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug

- Has exposed to more than 4 new chemical entities within 12 months before the first dosing day

- Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug

- Use of St. John's Wort within 28 days before the first dose of study drug

- Subjects not willing to follow study specified life style restrictions

- Blood donation in excess of 500 mL within a 56 days period

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment


Intervention

Drug:
GSK580416


Locations

Country Name City State
Australia GSK Investigational Site Randwick, Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study. during the study
Secondary Blood samples to determine drug levels in the body will be collected during the study. during the study
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