A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686
July 5, 2017 updated by: GlaxoSmithKline
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
A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers
Study Overview
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Middlesex
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Harrow, Middlesex, United Kingdom, HA1 3UJ
- GSK Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Part A
Single dose escalation
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Safety and tolerability dose escalation in normal human volunteers
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Other: Part B
14 day repeat dose escalation
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Safety and tolerability dose escalation in normal human volunteers
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Other: Part C
Fixed dose food effect
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Safety and tolerability dose escalation in normal human volunteers
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What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: 72 hours and 14 days
|
72 hours and 14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PK parameters per protocol
Time Frame: 72 hours and 14 days
|
72 hours and 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2008
Primary Completion (Actual)
May 27, 2009
Study Completion (Actual)
May 27, 2009
Study Registration Dates
First Submitted
July 22, 2008
First Submitted That Met QC Criteria
July 23, 2008
First Posted (Estimate)
July 24, 2008
Study Record Updates
Last Update Posted (Actual)
July 7, 2017
Last Update Submitted That Met QC Criteria
July 5, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Clinical Study Report
Information identifier: 111406Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 111406Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 111406Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 111406Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 111406Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 111406Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 111406Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.