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

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

Official Title
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A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers Using a Dose-Escalating, Randomized, Placebo-Controlled Study Design

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Drug: GSK1399686


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Part A<br>Single dose escalation | Drug: GSK1399686<br>* Safety and tolerability dose escalation in normal human volunteers<br>|
| Other: Part B<br>14 day repeat dose escalation | Drug: GSK1399686<br>* Safety and tolerability dose escalation in normal human volunteers<br>|
| Other: Part C<br>Fixed dose food effect | Drug: GSK1399686<br>* Safety and tolerability dose escalation in normal human volunteers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters per protocol |  | 72 hours and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, Phase 1, first time in humans, IBD, safety, human volunteers