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Succinate Salt Version of GSK961081 for Healthy Volunteers

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GSK961081
GSK961081 matching placebo
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring succinate, anti-muscarinic, b-agonist

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adult males or female aged between 18 and 50 years.
  • Body mass index within the range 19-29.9 kilograms/metre2
  • Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7
  • Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.

Exclusion criteria:

  • Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
  • History of respiratory disease
  • Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec
  • Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
  • Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
  • Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
  • Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months
  • Infected with the Hepatitis B, Hepatitis C, or HIV virus
  • Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Sequence 7

Sequence 8

Arm Description

In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.

In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.

In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.

In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.

In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.

In session 1, subjects will receive placebo followed by 900 micrograms of GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.

In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.

In session 1, subjects will receive placebo followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.

Outcomes

Primary Outcome Measures

FEV1 at intervals
Cardiac monitoring at intervals

Secondary Outcome Measures

Plasma concentrations of GSK961081 at intervals
PK parameters at intervals

Full Information

First Posted
October 26, 2007
Last Updated
September 28, 2021
Sponsor
Theravance Biopharma
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00550225
Brief Title
Succinate Salt Version of GSK961081 for Healthy Volunteers
Official Title
A Randomised, Double-blind, Dose Escalating Study in Healthy Volunteers to Assess the Safety, Tolerability, Extra Pulmonary Pharmacodynamics and Pharmacokinetics of Single Doses of GSK961081 (Succinate Salt)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2007 (Actual)
Primary Completion Date
January 8, 2008 (Actual)
Study Completion Date
January 8, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Salt Bridging study for GSK961081

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
succinate, anti-muscarinic, b-agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
In session 1, subjects will receive placebo followed by 900 micrograms of GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
Arm Title
Sequence 7
Arm Type
Experimental
Arm Description
In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
Arm Title
Sequence 8
Arm Type
Experimental
Arm Description
In session 1, subjects will receive placebo followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
Intervention Type
Drug
Intervention Name(s)
GSK961081
Intervention Description
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
Intervention Type
Drug
Intervention Name(s)
GSK961081 matching placebo
Intervention Description
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Primary Outcome Measure Information:
Title
FEV1 at intervals
Time Frame
during the 10 week study
Title
Cardiac monitoring at intervals
Time Frame
during the 10 week study
Secondary Outcome Measure Information:
Title
Plasma concentrations of GSK961081 at intervals
Time Frame
during the 10 week study
Title
PK parameters at intervals
Time Frame
during the 10week study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult males or female aged between 18 and 50 years. Body mass index within the range 19-29.9 kilograms/metre2 Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7 Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years. Exclusion criteria: Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject History of respiratory disease Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening. Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort. Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months Infected with the Hepatitis B, Hepatitis C, or HIV virus Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
NW10 7NS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MAB108115
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MAB108115
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MAB108115
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MAB108115
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MAB108115
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MAB108115
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
MAB108115
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Succinate Salt Version of GSK961081 for Healthy Volunteers

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