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

NCT01827631 | Completed Phase 1

• 1 other identifier: 116416
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn's Disease

Keywords

healthy; GSK1605786; CCR9 receptor antagonist; Chinese subjects; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Cmax

  maximum concentration after single dose and repeat dose

  up to 72 hour post dose

• AUC(0-τ)

  area under the concentration time curve during steady state

  up to 24 hour post last dose

Secondary Outcomes (3)

• adverse events (AEs)

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

• vital signs

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

• lab assessment

  Day 17 prior to leaving the clinic

Study Arms (2)

GSK1605786 500 mg once daily

EXPERIMENTAL

GSK1605786 500 mg is given once daily in the morning

Drug: GSK1605786 capsule

GSK1605786 500 mg twice daily

EXPERIMENTAL

GSK1605786 500 mg is given twice daily in the morning and in the evening

Drug: GSK1605786 capsule

Interventions

GSK1605786 capsule DRUG

Swedish Orange, size 0, hard gelatine capsules

GSK1605786 500 mg once daily; GSK1605786 500 mg twice daily

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Shanghai, 200025, China

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 116416 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 9, 2013
• Study Start: May 27, 2013
• Primary Completion: June 14, 2013
• Study Completion: June 25, 2013
• Last Updated: June 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)