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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00721812

First received: July 22, 2008

Last updated: March 17, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 22, 2008

Last Updated Date

March 17, 2010

Start Date ^ICMJE

September 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

• 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 [ Time Frame: 72 hours and 14 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00721812 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PK parameters per protocol [ Time Frame: 72 hours and 14 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

GSK1399686 PK parameters AUC Cmax elimination and absorption rate constants terminal phase half life accumulation index and Cmax over 14 days

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Inflammatory Bowel Disease

Intervention ^ICMJE

Drug: GSK1399686

Safety and tolerability dose escalation in normal human volunteers

Study Arm (s)

Part C
Fixed dose food effect

Intervention: Drug: GSK1399686
Part A
Single dose escalation

Intervention: Drug: GSK1399686
Part B
14 day repeat dose escalation

Intervention: Drug: GSK1399686

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00721812

Other Study ID Numbers ^ICMJE

111406

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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