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NCT Number: NCT01827631

Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects

This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Shanghai, 200025, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG
  • Male or female between 18 and 45 years of age
  • Body weight 50 kg (110lbs) for men and women, and body mass index (BMI) within the range 19 24 kg/m2

Exclusion criteria

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • Current or chronic history of liver disease, or known hepatic or biliary
  • A positive test for HIV antibody at screening
  • Known coeliac disease and positive serologic testing for anti-tTG antibodies
  • A positive pre-study drug/alcohol screen
  • Lactating females

Treatment and study plan

GSK1605786 capsule

Drug

Swedish Orange, size 0, hard gelatine capsules

Primary outcomes

  1. Cmax

    Time frame: up to 72 hour post dose

    maximum concentration after single dose and repeat dose

  2. AUC(0-τ)

    Time frame: up to 24 hour post last dose

    area under the concentration time curve during steady state

Secondary outcomes

  1. adverse events (AEs)

    Time frame: up to 21 days, from the first dose until the follow-up visit

    AEs occur during the study

  2. vital signs

    Time frame: before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic

    blood pressure, pulse rate, respiratory rate and temperature

  3. lab assessment

    Time frame: Day 17 prior to leaving the clinic

    Hematology/Clinical Chemistry/Urinalysis test

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 9, 2013
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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