A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686

Phase 1

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: GSK1399686

• Registration Number: NCT00721812
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-24
• Study Start: 2008-09-25
• Primary Completion: 2009-05-27
• Study Completion: 2009-05-27
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A	GSK1399686	Single dose escalation
Part B	GSK1399686	14 day repeat dose escalation
Part C	GSK1399686	Fixed dose food effect

Primary Outcome Measures

Name	Time	Method
• Safety and tolerability as determined by AE reporting and treatment effects on vital signs, ECG findings, haematology, clinical chemistry and urinalysis parameters, as well as 24-hour plasma cortisol profiles	72 hours and 14 days

Secondary Outcome Measures

Name	Time	Method
PK parameters per protocol	72 hours and 14 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Harrow, Middlesex, United Kingdom