Study To Examine Safety, Tolerability And Pharmacokinetic... | NCT00500461

Studies
Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705

NCT00500461

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Aug 7, 2017Actual

Enrollment

9Actual

Phase

Phase 1

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK233705

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2007Actual

Primary Completion Date

Jul 1, 2007Actual

Completion Date

Jul 25, 2007Actual

First Submitted Date

Jul 10, 2007

First Submission Date that Met QC Criteria

Jul 10, 2007

First Posted Date

Jul 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2017

Last Update Posted Date

Aug 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is to confirm an IV and oral dose for a definitive human radiolabel metabolic study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects receiving GSK233705	Experimental	Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points.	Drug: GSK233705

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK233705	Drug	GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.	Subjects receiving GSK233705

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,		out to 8 hours post dose
measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and		out to 24 hours
review of adverse events ongoing through out study.		through out study.

Secondary Outcomes

Measure	Description	Time Frame
Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose.		out to 48 hours post dose.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subjects;
Between the ages of 18-55 years, inclusive
Body mass index within the range 18.0 to 30.0 kg/m2.
Non-smokers
Adequate venous access for intermittent cannulation
A signed and dated written informed consent is obtained from the subject
The subject is capable of giving informed consent
Available to complete the study

Exclusion Criteria:

Any clinically important abnormality identified in the following: at the screening medical assessment
A mean QTc(B) value at screening >450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
A mean heart rate outside the range of 40-90 bpm at screening.
History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening.
The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
The subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort.
The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study.
The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing.
The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		London		NW10 7NS	United Kingdom

PubMed Identifier	Type	Citation	Retractions
	Background	This study has not been published in the scientific literature.

Label	URL
Results for study AC2106213 can be found on the GSK Clinical Study Register.	View source

ID	Type	URL	Comment
AC2106213	Dataset Specification	View IPD

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease