Phase I Study of GW642444M in Healthy Japanese Male Subjects

NCT ID: NCT00964249

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-20
• Study Completion Date: 2008-12-01

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

LABA

After randomization subject will inhale either 12.5 microgram or 25 microgram GW642444M once daily for 7 days.

Group Type: EXPERIMENTAL

GW642444

Intervention Type: DRUG

Long acting Beta 2 agonist

Placebo

After randomization subjects will inhale placebo once daily for 7 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

GW642444

Long acting Beta 2 agonist

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Fukuoka, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 23735179 (View on PubMed)

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

112017

Identifier Type: -

Identifier Source: org_study_id

NCT00753701

Identifier Type: -

Identifier Source: nct_alias