A Study of GSK573719 in Healthy Japanese Male Subjects

Phase I Study of GSK573719 -A Randomized, Double Blind, Placebo Controlled, Dose Ascending, Single and Repeat Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled Dose of GSK573719 From a Novel Dry Powder Device in Healthy Japanese Male Subjects

This is a single centre, randomized, double blind, placebo controlled, single and repeat dose study to investigate the safety, tolerability, and pharmacokinetics of inhaled dose of GSK573719 with lactose and containing magnesium stearate by a novel dry powder device in healthy Japanese male subjects.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: GSK573719 250 μg; Drug: GSK573719 500 μg; Drug: GSK573719 1000 μg; Drug: GSK573719 matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kagoshima, Japan, 890-0081
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests.
2. Body weight ≥ 50kg and BMI within the range 18.5-25.0kg/m2 inclusive.
3. Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked))
4. Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).

5. Clinical laboratory tests data obtained at screening meet the following:

   AST(GOT), ALT(GPT), total-bilirubin: below the upper limit of the normal ranges

6. Normal 12-lead EGC finding at screening; QTc(B) interval <450msec
7. A mean blood pressure lower than 140/90mmHg at screening.
8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
9. Capable of using the novel dry powder inhaler.

Exclusion Criteria:

1. The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
2. The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
3. The subject is positive for urine drug screening.
4. The subject has an allergy for any drug or idiosyncrasy
5. The subject has a history of breathing problems (i.e. history of asthmatic symptomatology).
6. The subject has a history of cardiovascular disease.
7. The subject has a significant clinical history or current conditions of glaucoma.
8. The subject has a significant clinical history or current conditions of prostatic hypertrophy.
9. The subject has a history of drug abuse or alcoholism.
10. The subject has a history of cholecystectomy or biliary tract disease.
11. History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 month of screening.
12. Use of prescription or non-prescription drugs, including CYP3A/PGP inhibitor, vitamins, herbal and dietary supplements (including St John'sWort) within 14 days prior to the first dose of study medication.
13. The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
14. The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
15. The subject has an allergy for any drug hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate.
16. The subject has donated a unit of blood ">400 mL" within the previous 4 months or ">200 mL" within the previous 1 month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSK573719 250 microgram (μg) arm; Each subject will receive the first dose of GSK573719 250 μg on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler.	Drug: GSK573719 250 μg; Strip 1 of the dry powder inhaler will contain GSK573719 250 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.
Experimental: GSK573719 500 μg arm; Each subject will receive the first dose of GSK573719 500 μg on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler.	Drug: GSK573719 500 μg; Strip 1 of the dry powder inhaler will contain GSK573719 500 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.
Experimental: GSK573719 1000 μg arm; Each subject will receive the first dose of GSK573719 1000 μg on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler.	Drug: GSK573719 1000 μg; Strips 1 and 2 of the dry powder inhaler will contain 500 μg each of GSK573719 micronized drug with lactose along with magnesium stearate. It will be available as dry off white powder for inhalation.
Placebo Comparator: Placebo; Each subject will receive GSK573719 matching placebo on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler.	Drug: GSK573719 matching Placebo; Strip 1 and 2 of the dry powder inhaler will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
PK: Cmax, tmax and AUC(0-t)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2009
• Primary Completion (Actual): December 18, 2009
• Study Completion (Actual): December 18, 2009

Study Registration Dates

• First Submitted: November 12, 2009
• First Submitted That Met QC Criteria: November 12, 2009
• First Posted (Estimate): November 16, 2009

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 113377

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

1. Dataset Specification
   Information identifier: 113377
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 113377
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 113377
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Annotated Case Report Form
   Information identifier: 113377
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 113377
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 113377
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: 113377
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register