Succinate Salt Version of GSK961081 for Healthy Volunteers

NCT00550225 | Completed Phase 1

• 1 other identifier: MAB108115
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Salt Bridging study for GSK961081

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

succinate; anti-muscarinic; b-agonist

Outcome Measures

Primary Outcomes (2)

• FEV1 at intervals

  during the 10 week study

• Cardiac monitoring at intervals

  during the 10 week study

Secondary Outcomes (2)

• Plasma concentrations of GSK961081 at intervals

  during the 10 week study

• PK parameters at intervals

  during the 10week study

Study Arms (8)

Sequence 1

EXPERIMENTAL

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.

Drug: GSK961081; Drug: GSK961081 matching placebo

Sequence 2

EXPERIMENTAL

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.

Drug: GSK961081; Drug: GSK961081 matching placebo

Sequence 3

EXPERIMENTAL

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.

Drug: GSK961081; Drug: GSK961081 matching placebo

Sequence 4

EXPERIMENTAL

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.

Drug: GSK961081; Drug: GSK961081 matching placebo

Sequence 5

EXPERIMENTAL

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.

Drug: GSK961081; Drug: GSK961081 matching placebo

Sequence 6

EXPERIMENTAL

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.

Drug: GSK961081; Drug: GSK961081 matching placebo

Sequence 7

EXPERIMENTAL

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.

Drug: GSK961081; Drug: GSK961081 matching placebo

Sequence 8

EXPERIMENTAL

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.

Drug: GSK961081; Drug: GSK961081 matching placebo

Interventions

GSK961081 DRUG

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.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6; Sequence 7; Sequence 8

GSK961081 matching placebo DRUG

GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6; Sequence 7; Sequence 8

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Theravance Biopharma: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

GSK Investigational Site

London, NW10 7NS, United Kingdom

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study MAB108115 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

batefenterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 29, 2007
• Study Start: November 29, 2007
• Primary Completion: January 8, 2008
• Study Completion: January 8, 2008
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)