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

NCT00721812 | Completed Phase 1

• 1 other identifier: 111406
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Diseases

Keywords

pharmacokinetics; Phase 1; first time in humans; IBD; safety; human volunteers

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (1)

• PK parameters per protocol

  72 hours and 14 days

Study Arms (3)

Part A

OTHER

Single dose escalation

Drug: GSK1399686

Part B

OTHER

14 day repeat dose escalation

Drug: GSK1399686

Part C

OTHER

Fixed dose food effect

Drug: GSK1399686

Interventions

GSK1399686 DRUG

Safety and tolerability dose escalation in normal human volunteers

Part A; Part B; Part C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy as determined by a responsible physician
• Male, or only for the RDF cohort female of non-childbearing potential, between 18 and 65 years of age.
• Body weight greater than 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 (inclusive).
• QTcB or QTcF \< 450 msec
• Capable of giving written informed consent

You may not qualify if:

• The subject has a positive pre-study drug/alcohol screen
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units
• Urinary cotinine levels indicative of active smoking or regular use of tobacco
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
• A positive test for HIV antibody
• The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives of the investigational product
• Exposure to more than four new chemical entities within 12 months
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days
• Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices within 7 days
• Subject is receiving hormone replacement therapy
• History of sensitivity to any of the study medications
• History of sensitivity to heparin or heparin-induced thrombocytopenia

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

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 111406 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: September 25, 2008
• Primary Completion: May 27, 2009
• Study Completion: May 27, 2009
• Last Updated: July 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)