Phase I Study of GW642444M in Healthy Japanese Male Subjects

Phase I Study of GW642444M- A Randomized, Double Blind, Placebo Controlled, Parallel-group, 7 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Dose of GW642444M From a Novel Dry Powder Device in Healthy Japanese Male Subjects -

This is a randomized, double blind, placebo controlled, parallel-group, 7 day repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose of GW642444M from a novel dry powder device in healthy Japanese male subjects.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Placebo; Drug: GW642444

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• 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. Serum potassium and glucose within normal range at screening
7. Normal 12-lead EGC finding at screening; QTc interval <450msec
8. A mean heart rate within the range 40-90 beats per minute (bpm) inclusive at screening.
9. A mean blood pressure lower than 140/90mmHg at screening.
10. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
11. 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 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.
3. The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
4. A history of breathing problems (i.e. history of asthmatic symptomatology, asthma in childhood).
5. The subject has an allergy for any drug or idiosyncrasy
6. The subject has a known allergy or hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate.
7. The subject has a history or current conditions of drug abuse or alcoholism.
8. History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink=5 ounces (150mL) of wine or 350mL of beer or 1.5 ounces (45mL) of 80 proof distilled spirits) within 6 month of screening.
9. The subject is positive for urine drug screening.
10. 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.
11. The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
12. The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" within the previous 1 month.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; After randomization subjects will inhale placebo once daily for 7 days.	Drug: Placebo; Matching placebo
Experimental: LABA; After randomization subject will inhale either 12.5 microgram or 25 microgram GW642444M once daily for 7 days.	Drug: GW642444; Long acting Beta 2 agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety：adverse events, vital sign, ECGs, and clinical laboratory test
PK：Cmax, tmax and AUC(0-t)

Secondary Outcome Measures

Outcome Measure
Pharmacodynamics parameters of the systemic β-adrenergic effect (heart rate, blood pressure, QTc, glucose and potassium)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Nakahara N, Wakamatsu A, Kempsford R, Allen A, Yamada M, Nohda S, Hirama T. The safety, pharmacokinetics and pharmacodynamics of a combination of fluticasone furoate and vilanterol in healthy Japanese subjects. Int J Clin Pharmacol Ther. 2013 Aug;51(8):660-71. doi: 10.5414/CP201822.

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): September 20, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 13, 2009
• First Submitted That Met QC Criteria: August 20, 2009
• First Posted (Estimate): August 24, 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: 112017

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. Annotated Case Report Form
   Information identifier: 112017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: 112017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 112017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 112017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: 112017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register