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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-25

Study Completion Date

2009-05-27

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

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Part A

Single dose escalation

Group Type OTHER

GSK1399686

Intervention Type DRUG

Safety and tolerability dose escalation in normal human volunteers

Part B

14 day repeat dose escalation

Group Type OTHER

GSK1399686

Intervention Type DRUG

Safety and tolerability dose escalation in normal human volunteers

Part C

Fixed dose food effect

Group Type OTHER

GSK1399686

Intervention Type DRUG

Safety and tolerability dose escalation in normal human volunteers

Interventions

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GSK1399686

Safety and tolerability dose escalation in normal human volunteers

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Harrow, Middlesex, United Kingdom

Site Status

Countries

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United Kingdom

Study Documents

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