Phase I Study of GW642444M in Healthy Japanese Male Subjects

NCT00964249 | Completed Phase 1

• 1 other identifier: 112017
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Safety：adverse events, vital sign, ECGs, and clinical laboratory test

• PK：Cmax, tmax and AUC(0-t)

Secondary Outcomes (1)

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

Study Arms (2)

LABA

EXPERIMENTAL

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

Drug: GW642444

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

GW642444 DRUG

Long acting Beta 2 agonist

LABA

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Body weight ≥ 50kg and BMI within the range 18.5-25.0kg/m2 inclusive.
• 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))
• Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).
• Clinical laboratory tests data obtained at screening meet the following:
• AST(GOT), ALT(GPT), total-bilirubin: below the upper limit of the normal ranges
• Serum potassium and glucose within normal range at screening
• Normal 12-lead EGC finding at screening; QTc interval \<450msec
• A mean heart rate within the range 40-90 beats per minute (bpm) inclusive at screening.
• A mean blood pressure lower than 140/90mmHg at screening.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Capable of using the novel dry powder inhaler.

You may not qualify if:

• 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.
• The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
• A history of breathing problems (i.e. history of asthmatic symptomatology, asthma in childhood).
• The subject has an allergy for any drug or idiosyncrasy
• The subject has a known allergy or hypersensitivity to milk protein or the excipients lactose monohydrate and magnesium stearate.
• The subject has a history or current conditions of drug abuse or alcoholism.
• 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.
• The subject is positive for urine drug screening.
• 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.
• The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
• The subject has donated a unit of blood "\>400mL" within the previous 4 months or "\>200mL" within the previous 1 month.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fukuoka, 812-0025, Japan

Location

Related Publications (1)

• 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.

  PMID: 23735179 BACKGROUND

Related Links

• Results for study 112017 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 24, 2009
• Study Start: September 20, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)