Inflammatory Bowel Diseases
Conditions
Keywords
pharmacokinetics, Phase 1, first time in humans, IBD, safety, human volunteers
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
Interventions
DRUGGSK1399686
Safety and tolerability dose escalation in normal human volunteers
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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
| Measure | Time frame |
|---|---|
| PK parameters per protocol | 72 hours and 14 days |
Countries
United Kingdom
Outcome results
None listed