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OpenTrials
Completed

NCT Number: NCT00550225

Succinate Salt Version of GSK961081 for Healthy Volunteers

Salt Bridging study for GSK961081

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

London, NW10 7NS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. FEV1 at intervals

    Time frame: during the 10 week study

  2. Cardiac monitoring at intervals

    Time frame: during the 10 week study

Secondary outcomes

  1. Plasma concentrations of GSK961081 at intervals

    Time frame: during the 10 week study

  2. PK parameters at intervals

    Time frame: during the 10week study

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 29, 2007
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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